If ever there was a company in the spine industry that has resembled a roller coaster, Amedica may be the poster child for the ups and downs of the world of spine. After raising north of $100 million to bring Silicon Nitride by storm into the industry, after making poor choices in leadership, after a failed attempt at taking the company public, could this be the defining moment that finally gives Amedica hope? As Clint Eastwood would say, "are you feeling lucky, of course to an empty chair."
On September 13th, Amedica issued two press releases announcing an expansion of its claims that their Silicon Nitride material has superior osteointegration and anti-infective capabilites when compared to the current state-of-the art. For years, PEEK has been considered the gold standard in inter-body due to its modulus of elasticity and versatility as a biomaterial. When comparing Silicon Nitride to PEEK the question must be asked, "will the expanded labeling of this product shift the standard of care for patients that need lumbar fusion?"
Amedica was quick to take advantage of these articles that were published in Acta Biomaterialia and the International Journal of Nanomedicine, which demonstrated that when comparing Silicon Nitride to PEEK or Titanium (is anyone actually using titanium interbody devices anymore?) there was superior bone formation, osteointegration, as well as anti-infective properties. Once again, questions abound whether surgeons are unhappy with the results when using PEEK and whatever magic dust is infused into an affected vertebral segment? Could these recent findings shift current market dynamics? As the government seeks to place a premium on evidence based medicine, will these findings improve patient outcomes? Is this much ado about nothing? Could this be another Hail Mary? Doug Flutie where are you? One of the most important statements in this press release focuses on the potential for higher reimbursements for surgeons and hospitals. A strategically placed statement? You be the judge. Does PEEK actually contribute to the colonization of bacteria which may reduce fusion rates? What are the infections rate in lumbar spine fusions?
Yet, before our readers go any further, we would like to know the relationship between Amedica and the surgeons involved in making statements regarding product efficacy (Skidmore) and findings regarding bacterial infections (Webster), a nano of transparency assuages everyones trepidation when reading these PR statements. TSB is not being a skeptic, TSB is asking the questions so that the court of public opinion can determine whether Amedica's claims are legitimate or as stated earlier much ado about nothing? Hey Amedica are you feeling lucky? To be? Or not to be? That is the question.
For years, I have heard anecdotal testimonials of better fusion rates with silicon nitride. Every time a distributor mentioned it to me, I would ask, "Let me see peer reviewed data and I may consder it." Well, I have read the abstracts and if the data is accurate, silicon nitride does, in fact, demonstrate vastly superior bone attachment when compared to PEEK. That one determination is something every serious, thoughtful spine surgeon should consider. But I was fascinated with the antimicrobial properties of silicon nitride. The data also show that silicon nitride is antibacterial. According to the study, after three months, there was no discernible presence of bacteria on the implant or anywhere in the surgical site. PEEK, on the other hand, was swimming in it.
ReplyDeleteI don't know if Obamacare will become the law of the land or not, but my hospitals are both focused on readmission rates and infection rates because every hospital that receives federal dollars is going to be graded on these items. If the hospitals don't have passing readmission or infection rates, their reimbursement dollars will disappear.
If silicon nitride demonstrates superior osteointegration AND antibacterial properties, I can't see how silicon nitride doesn't become the new gold standard of care in interbody fusion devices.
Kudos Amedica!
"PEEK, on the other hand, was swimming in it."
DeleteThat's a bold statement AMEDICA! If that is the case, then PEEK sterilization studies submitted to the FDA with each 510 (k)must be questioned? Oh yeah, AMEDICA sells PEEK products, too...! Hmmmmm!!!???
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DeleteDo you care about radiolucency?
DeleteTSB, are you serious? You write an entire blog post about a couple of obscure white papers published about Silicon Nitrade, but you say nothing about NuVasive's NeuroVision lawsuit being overturned by an appeals court? If my memory serves me correctly, you wrote a lengthy blog post about NuVasive when the initial $60M judgement was handed down. Now that it has been overturned, you write nothing. I have been reading your blog for quite some time now, and I have watched as you slowly but surely lost your integrity. It is obvious by now to everyone who reads your blog regularly that you have an agenda and that's sad. We used to respect you for your courage, but now we see that you are no different than the rest of the scum that infects our once proud industry.
ReplyDelete12:25 for someone whom doesn't pay a subscription rate to read a blog you do have a sense of entitlement. The people involved with TSB have the option to write whatever they want, don't like it, don't read it, besides this case isn't over it will be retried. Round 2 Score it in favor of Nuvasive, Round 3 TBD. Lawyers love our industry.
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Delete8:53am (aka MSM),
DeleteYour comment further proves my point.
12:25am
12:25 MSM here, I do have a life outside of TSB you should get one, if I have something to say I use my own moniker
DeleteBetter... let's blame MSM for all the problems in our screwed up healthcare system. The truth is (and I don't kow how he does it), MSM seems to know a lot about a lot BEFORE it happens. He provides little know and in many cases uncirculated information, asks provocative questions and let's the rest of us hash it out for ourselves in a public (albeit often times irreverent) forum. I have learned a thing or two on here and appreciate MSM's time and effort. If you want to hype NuVasive's great achievement of getting its legal case thrown out on a technicality, go start your own blog. Let the rest of us focus on cutting edge technologies in our industry.
Deletebull crap......MSM hasnt been right about half of his dire predictions. his correct predictions usually deal with companies my 10 year old could tell you are messed up....he is a bloviating punk that likes to call people names and stir up rumors. MSM knows a few people, been around a while......like the managers we have all said "Yea, i know Dr. Cocktoasten really well." during his interviews....but couldnt find his office to save.his life and never been in a case....Dr......really
DeleteTalk about a bloviator 9:46 you have everyone beat
DeleteBull Crap 9:46 go back into the archives, the rest is history
DeleteDo you all go onto every blog and complain when they blogger posts something you don't care about? I know I HATE it when my dinner recipe blogs post recipes that should only be for lunch, and man are they going to hear about it from me in the comments. And jeeze, when travel blogs post about places that I think aren't fun to visit, you know I'm going to be in those comments telling everyone that those places suck and nobody should visit.
DeleteIt's called the internet, quit complaining.
What ever happened with the Betamax?
ReplyDeleteBetamax (developed by Sony) offered much better resolution and superior technology when compared to VHS. It was just never presented or sold well, so VHS won the battle in the marketplace. Maybe that's why silicon nitride has never caught on... poorly managed commercialization efforts for three years and poorly marketed in spite of being superior technology. Will Amedica end up like Sony?
DeleteExcept that it isn't superior to PEEK or Titanium. It is unique, but doesn't really offer sufficient biological performance to make up for its poor mechanical suitability and xray performance.
DeleteI heard that K2M is using Amedica's silicon nitride in Europe. Any truth to this?
ReplyDeleteThat would be amazing validation of silicon nitride and Amedica IF it is true. Why would we be learning about this on a blog?!?!?! Nice try, though!
DeleteYup, TRUE.
DeleteWait til 4WEB introduces it's titanium cage at NASS this year. The animal studies and histology regarding complete osteointegration through the implant as well as it's structural support characteristics will blow you away. Likewise, it has osteoinductive properties due to it's unique configuration being a strut/triangle form beveled on it's edges like a cushion cut diamond. There IS innovation in the spine market today, this product will be well received and has huge use potential in orthopedics in general.
ReplyDeleteYou must be in the Texas market. Do you sell it?
DeleteTrabecular metal is far more outstanding than this "new" product in more ways than one. And definitely has not been as well received and game changing as you would think. Don't drink that kool-aid mister....
DeleteAt 11:01. My advice to you is to read the data on the 4WEB implant. Trabecular metal doesn't have bone grow through it, only up against it, while the 4 WEB implant has complete osteointegration/consolidation, and bone remodeling. In addition it acts like rebar in concrete. Your ignorance about the superiority of trabecular metal shows...
DeleteYou obviously do not have access or have read the data on trabecular metal. It's actually YOUR ignorance that's showing....
DeleteHow important is a large footprint in a TLIF? I know docs use XLIF of DLIF for the footprint, but what about in a TLIF? One of the docs in my territory is using a modular TLIF cage that he says gives him coverage from endplate to endplate and great results. Has anyone else seen this and how do you position against it? Looks difficult to assemble and time consuming, I can't find much clinical data on it.
ReplyDeleteWhat is the statuus of Spinal USA in Huntsville, Al? Is the story over? Surgeons manufacture implants. WSJ does expose. WSJ article is not printed locally in Huntsville. Physicians sell company. Life goes on?
ReplyDeletePEEK isn't as good for bone growth because it is hydrophobic, yet you get to easily assess fusion.
ReplyDeleteTitanium is better for bown growth but is harder to assess fusion. There is a surprisingly large group of guys using titanium out there.
This all sounds nice, did not see much mention of strength...
There are still dudes using bone....
Spinal USA - Did they sell the company or is it somehow affiliated with Spinal USA Inc. in Delaware? Didn't someone mention investigations earlier on this blog?
ReplyDeleteYou should look into who owns the AL-MS Group, LLC. Check out who Spinal USA and Precision lease their buildings from.
How do you get information on who they lease their buildings from? If you know, please enlighten us.
ReplyDeleteIt wouldn't matter if they discovered magic spine dust that cures all spine ailments non-invasively. The management team they have in place there is not capable of properly commercializing it.
ReplyDeleteThey have assembled the most unintelligent management team in spine. And that's saying something.
LMAO-
DeleteTo use a song anology as so often is the case with TSB: "Never gonna get it, never gonna get, never gonna get it... whoa-ooh ooh- ah"
Silicon nitride may sound a little sexy, but wait until you have to bang on it a little bit to get the cage into place... Shatter city. Very brittle.
ReplyDeleteAlso agree w/ comment regarding management.
Shatter city, i LOL'd.
DeleteSilicon nitride is used in industrial and commercial applications because of its toughness, strength and durability. The plates in our brave soldiers' bullet-proof body armor in Afghanistan are made out silicon nitride. Critical bearing components in aerospace and high performance race cars are made out of silicon nitride. To suggest that this material is brittle and would shatter when being manipulated and implanted during a surgery is about the most ridiculous thing I have heard all year. Nice try, though.
DeleteSilicon Nitride can shatter if point loaded. Call any material scientist familiar with the it and they will confirm this.
DeleteI've seen it shatter a number of times and watched the surgeon pull out the shards. I've also seen peek break(not shatter) and bone shatter. Does Silicon Nitride have superior oseointergration to allograft or autograft?
DeleteI've also seen all the materials spit out of the disc space and need to be revised.
How do you know you have all of the shards?
DeleteWhen that small and being radiolucent??
Good luck explaining that to your neural leaking patient! But, you know, at least you've got that b.s. petri dish study talking nonsense about baceteria working for you- you know, if you're into that sort of thing. lol
Silicon nitride is about 30 or more times more rigid than bone, so it shields stress and may cause implant migration into the vertebral body.
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DeleteSpinal USA sold to Precision Spine. They owner financed the deal. Now the original surgeon owners get interest on top of their other profits. Winning!!!!
ReplyDeleteWho's heading up sales at Lanx? Looks like there have been some changes.
ReplyDeleteDr. Andy Cappuccino, and I don't think anyone from Lanx would deny it
ReplyDeleteWhat a joke!
DeleteI haven't looked at Amedica for years... since they hired that scumbag Ben Schappley. I didn't realize they blew him out. For the first time in two years, I am going to revisit Amedica. Maybe they are getting their act together.
ReplyDeleteAmedica is getting much better and actually have some really good products and a few good guys in the management spot. They have the only triple lead screw on the market, and i think this silicon nitride could be a sweet new product. i think itll be very big especially in the knee/hip market eventually. ben shappley is gone and the new guy running the company seems to have his act together. we will see
ReplyDeleteTriple lead screws... no thanks. I'm holding out for the quadruple lead ones. What's the ETA?
DeleteEminent Spine has triple lead screws, according to their incredibly old website.
Delete"He seems to have his act together." Those self-evaluations are really in vogue right now, Eric. Good job.
DeleteJerry Summers will be VP of Sales very very soon....
DeleteJerry Summers? This guy is the biggest moron that ever lived. He doesn't know his head from his ass and was fired from every job he has had. On that subject, he should go back to
Deleteselling microscopes and power instruments because he has no business being in spine. Talk about a dishonest weasel, douche bag...Jerry Summers.
Eminent Spine's triple lead DiamondBack pedicle screw is the hottest on the market. Once a surgeon uses the DiamondBack triple lead screw, they won't go back. It is not just another screw, use it and you will know. Some do not understand the math behind leads. ES has always offer triple leads, even when most did not know what it was. Single and double leads are old school. ES is expected to launch the "Texas DiamondBack" at NASS, in Dallas, Texas.
DeleteHey 7:49 Eminent Spine employee, you should tell your customer relations people that your website is bad and you should feel bad.
DeleteEminent aka unEthical Spine? They truly ared bad to the bone and their products are even worse. Is Kortney still banging that whore Kimberly Williams or has Freehill moved on to tap that ass? This company is a joke.
DeleteAmedica? Sendro of Blackstone fame is the sales vp there. Not sure he would qualify as one of the few good guys in management
ReplyDeleteThe ceramic spacer is harder than bone...so is peek. If either subsides into the vertebra then you are not preserving enough of the endplate.
ReplyDeletethank you 8::20.....you could stick a diamond shaped implant in there and it would be the same thing as any other implant.....hold open the space until bone healing takes place.....if the endplates havent been shaved too thin....they only startr at 2-3 milimeters.....the rotatingscrapers are the worst ones
DeleteTo your question MSM
ReplyDeleteTwo papers in two journals that are essentially the same study and same group of patients.
But heres comes the rub;
DISCLOSURE B Sonny Bal is advisory surgeon to Amedica, developer of synthetic silicon nitride for orthopedic applications, and serves on the Board of Directors of Amedica, Salt Lake City, UT.
there ain't no science like sponsored science...!
bingo! Webster's research was also sponsored. The "patients" in the research are rats...
Delete"Dr. Bal is an Associate Professor of Orthopaedic Surgery at the University of Missouri, Columbia, specializing in hip and knee replacement surgery. He also is an Adjunct Professor of Material Sciences at the University of Missouri "
DeleteOrthopedic Surgeon, Professor of Material Sciences, over 100 publications...yeah, he doesn't sound qualified at all to be involved in this study...(rolls eyes)
How many (human) patients has Dr. Bal implanted Silicon Nitride into and tracked outcomes? I read the links and both studies said rats were used.
DeleteI think Amedica should report on clinical human outcomes. Maybe, Skidmore will publish???
Dr. Bal has NEVER implanted a spacer EVER. He is a total joint guy that invested mucho dinero many years ago and surely is wanting to get his money back.
DeleteAmedica's SiN was never intended for spine but for total joints due to the hardness and intended "40 year joint" Spine was an after thought due to the FDA slam dunking them on the 510k for joints. The "squeaked" in on a VBR for spine.
All the original surgeon investors, (nearly 450) are general orthopedist. NOT SPINE.
Don't believe this hype!
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DeleteNot to be... Silicon Nitride is too stiff to enable Wolff's law of fusion due to stress shielding. It does not allow the clear assessment of fusion under x-ray because it is too dense. And, it doesn't have the biological attributes of titanium. Why not use PEEK because it is better under x-ray and stiffness? Or why not use titanium because it is better for osteogenesis?
ReplyDeleteWhat is Wolff's Law of Fusion? Sounds like someone with a small bit of knowledge......
ReplyDeleteReally???
DeleteLook it up!
DeleteStress shielding? With that kind of thinking Ti, PEEK and Silicon Nitride are all too "stiff". More appropriate, all are harder than bone. That is not the point of Amedica's new claims. The new claims detail the superiority of Silicon Nitride over PEEK and Ti in regards to osteointegration (celluar attachment), as well as the anti-infective properties. Cells do not attach to plastic or PEEK. Cells may attach to Ti particularly if the surface has been manipulated or roughned. But to try and refer to Wolff's law, stiffness, hardness or modulous of elasticity as a downfall of SiNi then the same is true of PEEK and Ti. All are too hard. Proper endplate preparation is key to the structural integrity of the interbody space. The size of the opening in these spacers should be considered (i.e. more graft contacting the endplate the better). Maintaining the height of the interbody space, all the cages are same. What Amedica is claiming now is their actual material is superior to plastic and Ti. 7:55 give up on the "stiffness" argument.
ReplyDeleteAmedica is trying to "split hairs" with their argument. Titan Spine has a much better story to tell with regard to bone integration into the ssurface of their implant. PEEK..not so good either.
Delete1:40PM - PEEK has a modulus between that of cortical and cancellous bone, so it is perfect.
DeleteThat argument was establish by good old MSD. Why?? They were the only one's that initially had PEEK. True is..it's not that important. Stp drinking the Kool Aid!
DeleteWhen discussing different inter body options on this site, a reoccurring theme seems to prevail. Endplate prep. Seems there should be a focus on solutions to achieve this beyond the usual curettes and especially paddle scrapers which are way too aggressive and violate endplates. What technologies are out there that can get to bleeding bone without being too aggressive and can safely clean entire endplate. Seems like better money spent than the "new" implant. After all, if the endplate isn't prepped properly, it doesn't matter which implant you use. If it is prepped properly, it also doesn't matter which implant you use. In other words, quit wasting money on fancy implants and designer biologics. Spend the money on disc prep technologies. Better outcomes and lower costs.
Delete9:49 PM - You are wrong. Medtronic was not the first ones with PEEK. JNJ was the first with carbon fiber PEEK interbody devices, which has a compressive modulus between cortical and cancellous bone similar to plain PEEK. Medtronic was with the rest of the pack (with cement restrictors by the way), not ahead of it. You have obviously been drinking the Kool Aid from Amedica. IMO ceramic doesn't present a valid advantage over PEEK or titanium. It's not terrible, but not as good as PEEK or titanium. PEEK is superior to ceramic for stiffness and radiolucentcy. Titanium is superior to ceramic for osteoinductive performance.
DeleteTo be more accurate CFRP (Carbon Fiber Reinforced Polymer) came from John Brannigan MD of Acromed fame, later acquired by DePuy and again and ultimately by J&J in 1998. To claim CFRP or PEEK or any plastic cages fall between cortical and cancellous bone is foolish. “Bone” is not quantifiable as an absolute; everyone’s density is different. To say plastic is closer in modulous to bone than say ceramic or Ti is technically accurate but not clinically significant (analogous to saying S.Carolina is closer to the South Pole than N.Carolina...again, makes no difference clinically). All the cages are harder than the diseased surfaces where they are being placed and all will subside as others have said if the endplate is not prepped properly or maybe already damaged beyond support.
DeleteThe key to Amedica’s claim is that the material itself is more friendly to the success in healing and overall outcome. I have not seen any evidence showing where PEEK or plastic, as a material, aids in bio-ongrowth, cellular attachment and has an anti-infective property. Plastic inherently resists cellular attachment and the human body seems to try and reject the material (particularly in the lumbar spine where forces, both compressive, torsional and shear are greater). It is in this environment where having an implant made of a material that is more friendly to the outcome and in fact may aid in the healing is interesting.
I believe the data on Ti, especially when the surface has been roughened, show a similar bio-friendly response. I do believe that Amedica and Titan (and any other companies with Ti cages) are on to something and PEEK spacers in the current form have become a less desirable option.
10:19 AM - Facts just don't support your position on the mechanical properties of the materials. You are correct about the Brannigan cage (although others claim to have done most of the work). Cortical bone in the spine has a stiffness of 17 GPa. Cancellous is 0.1 to 2 GPa. PEEK is 4, Titanium is 100, and Silicon Nitride is 310. PEEK is certainly between cortical and cancellous bone, while Ti is nearly 6 times more rigid, and SiN is nearly 18 times more rigid than cortical bone. No matter what you say, Ti out performs SiN for modulus, radiolucentcy, and bioactivity. PEEK out performs Ti and SiN on modulus and radiolucentcy. And both Ti and SiN out perform PEEK on bioactivity. The best product would somehow have the radiolucentcy and modulus of PEEK with the bioactivity of Ti. 10:19 AM - Good luck trying to sell your SiN material, you'll certainly need it.
DeleteI have never heard of either of the journals of which their products were published.
DeleteI have heard of The Spine Journal. Titan Spine's surface technology was published in March 2012. Seems a hell of a lot more relevant than a geek mag and splitting hairs at that...
By the way, how does bone attach to a "moving" target, just curious.
There is a Indian gentlemen (Mr. L.) who is a scientist within ranks of Amedica. His own words are that "SiN is completely inert." Their regulatory guy is also an advocate of that word "inert" as that is how it was cleared with the FDA.
Deleteooops!
I wonder how the FDA will respond now knowing that these "peer reviewed" articles are showing bio-activity and cellular repulsion of bacteria. Sounds like they will need to be pulled and do some more (real) studies, eh boys?!
Yep, you done stepped in your own pile of B.S. LOL!
Somebody please make the call.
The entire stiffness debate PEEK vs. SiN vs. Ti vs. cancellous vs. cortical bone is seriously flawed as it's missing one important aspect: You don't implant a massive block of either material (besides bone graft).
DeleteDue to the central and circumferential openings a cage becomes much weaker. The axial stiffness gets reduced and is at least as dependent on the design as it is on the material.
The "stiffness similar to bone" argument Invibio came up to promote PEEK is nice as it's so easy to swallow and "makes so much sense"...but in reality it is pure marketing nonsense in both, theory and practice.
Define splitting hairs? What is the titan story? Can you see bone through Ti?
ReplyDeleteAmedica's impant material does not make much of a difference from PEEK. Of course you can't "see" through Ti. You can "see" through open parts of the implant to assess fusion. Take some time to go on their website and learn weed hopper.
DeleteI encourage you to go through both booth's at NASS- or websites for that matter.
DeleteThe difference in assessment of fusion will be massive.
Amedica SiN is like viewing FOG through a FOG. I think I see some fusion after 6/12 months.
Titan is a wide open massive window, like a convertible on a sunny day. There is no comparison.
Different topic but a great read from Fortune on the Synthes-Norian debacle.
ReplyDeletehttp://features.blogs.fortune.cnn.com/2012/09/18/synthes-norian-criminal/
As a former SUSA employee I can confirm a number of the points within the article. Glad to be out of that hornets nest
DeleteWhat a nisrable story.
DeleteThank you for posting that, it was a very good read.
DeleteI would love to see a large scale study (more than 35 "patients")of the infection rate for spine fusion and how it relates to the inter body material. There are way to many factors involved to narrow it down to which material is used. That would seem the only way to prove it has any relevance. As far as bony on or ingrowth, what happens in a petri dish or rat study doesn't necessarily indicate human performance. The lumen in interrbody devices is there to allow the auto or allograft to incorporate to the endplates through the spacer. Does SiNi incorporate faster than bone?
ReplyDeleteSiNi does not "incorporate faster than bone". That is not the claim. The claim is that there is boney attachment to the material itself unlike plastic which resists attachment. SiNi participates in the fusion vs. resisting the fusion. Bone grows through the opening of a SiNi cage at the same rate as it does through the opening of a plastic cage. The difference being the portion of the cage which touches the endplates also attaches. Thereby, you have less cage migration, cage loosening, back out, etc. The material itself is bone friendly. The SiNi spacer becomes the fusion. You can disagree but understand the argument.
DeleteIf you walked through a heavy rain storm wearing a plastic Gore-Tex jacket and then again wearing a heavy cotton flannel shirt...in which situation would you attract more water?
Lastly, I agree. I too would like to see a larger scale study regarding the infection claim.
Dr. Boriani presented similar data which suggests greater cellular adhesion with carbon composite implants as compared to PEEK implants:
DeleteCARBON FIBRE RENFORCED POLYMER (CFRP) CAGE INDUCES BETTER CELLS ADHESION,
SPREADING AND PROLIFERATION THAN POLI-ETERE-ETRE-KETONE (PEEK) CAGE.
ANALYSIS BY A NEW CELLULAR MODEL FOR IN VITRO STUDY OF ORTHOPAEDIC BIOMATERIALS
1G. Barbanti Bròdano, 2C. Morelli, 1A. Gasbarrini, 2C. Di Bona, 2M. Tognon , 1S. Boriani
1Ortopedia e Traumatologia – Chirurgia del Rachide, Ospedale Maggiore “C.A. Pizzardi”,AUSL Bologna, Italy
2Department of Morphology and Embryology, and Center of Biotechnology, University of Ferrara, Ferrara, Italy
those fiber splinters are great for the canal
Deletecarbon fibers are polymerized within the host plastic which ostensibly prevents this type of occurrence--unless you have some data that disputes that?
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DeleteInfections in ACDF are exceedingly rare.
ReplyDeleteThe most common complications were: wound infection (0.3%.
DeleteThe majority of studies document 95%-100% fusion rates when iliac crest autograft is utilized to perform single level ACDF (X-ray or CT confirmed at 6-12 postoperative months). Although many allograft studies similarly quote 90%-100% fusion rates (X-ray alone confirmed at 6-12 postoperative months), a recent "post hoc analysis of data from a prospective multicenter trial" (Riew KD et. al., CSRS Abstract Dec. 2011; unpublished) revealed a much higher delayed fusion rate using allografts at one year 55.7%, 2 years 87%, and four years 92%.
Conclusion: Iliac crest autograft utilized for single or multilevel ACDF is associated with the highest fusion, lowest complication rates, and significantly lower costs compared with allograft, cages, PEEK, or other grafts. As spinal surgeons and institutions become more cost conscious, we will have to account for the "value added" of these increasingly expensive graft constructs.
Yes, but unfortunately iliac crest autograft is also associated with a fairly substantial incidence of donor site pain. Hence the appetite for alternatives.
DeleteCommonly used in Europe which begs the question -- is it really associated with "substantial" incidence of pain or are there other reasons associated with the easiness of using bone substitute, cadaver bone, etc?
DeleteThank you MSM for this forum. It is clear that many of the people commenting on this subject have a stake in maintaining the status quo and PEEK's continued dominance in inter-body procedures. I have reviewed the white papers (which were indepentdently peer-reviewed) and I have no doubt that, if these claims are accurate, PEEK has seen its best days and its market position will decline. Yell at the moon, kick your dog or whistle past the graveyard... when all is said and done, silicon nitride appears to be a better mousetrap.
ReplyDeleteAgee with almost all you said. Titan impant is btter than both.
DeleteYou have to give Amedica credit. They are taking this thread seriously. Lot's of obvious Amedica employee rah-rahs on here. Must have been a memo circulated in SLC. So sales at Amedica will finally skyrocket. Riiiiiiiight.
ReplyDeleteThey are fighting for their lives after all. This ship has taken on too much water however.
Delete3:18am Fighting for their lives? Really? What planet are you living on?!?!? This little company is apparently now profitable, has millions of dollars in the bank and is the only company in the space who can make claims of superior bone attachment and anti-bacterial properties. Oh, yah, and the company has the intellectual property locked up and they are the only company who can sell silicon nitride medical devices. Yes, you have Amedica shaking in their boots.
DeleteAnybody know about this? http://www.prweb.com/releases/2012/8/prweb9757953.htm PEEK Ti combo implant.
Delete6:34, you really are embarrassing yourself and your company. Your post drips of that arrogance of "pending world domination" that has characterized Amedica, but has always been undermined by management's ineptitude. It's ten years and $100 million in blown investment into the game, dude, no one is buying it any more.
Delete9:09 AM - Amen.
DeleteProfitable? Millions in the bank? Basic spine business knowledge would suggest this is BS. Ameidca is making a last ditch effort to save the sinking ship and return something (even if pennies) to the hundreds of investors that have continued to been lied to and forked over 120-140 million over the years.
DeleteYoooo 6:34 - You stated that " you are the only company who can sell silicon nitride medical devices". One stupid question:
DeleteWHEN ARE YOU GOING TO ACTUALLY START DOING THAT????
Please... they are making a last ditch effort not to sink and to sell for pennies to Zimmer. They have a nice factory for SiN problem is no one wants it. There stuff is and always will be a missed opportunity for joints.
DeleteHence, Zimmer will sweep up the shards, I mean pieces, and finish out a PMA for the joint called the 40 Year Squeeker.
Hypothetical Legal Question… What happens if a distributor in the sunshine state representing a company anxL sets up a development deal with a company based in the Buckeye State based for a Spinous Process plate. The whole deal is spearheaded through the buckeye state spine companies VP and anxL trays are shipped to the buckeye state for “Development” What law has been broken? What liability do the VP and the Buckeye State Spine company share? What liability does the distributor in The Sunshine State have?
ReplyDeleteand how would you like to pay for this advice, sir
DeleteNow that's some funny stuff! Please keep us all posted when the court documents are filed.
DeleteHmmmm. Curious, Watson. Would X mark the spot in the Buckeye State?
DeleteSo Plasticine Jo is at it again!!! Trade secrets....Funny thing is that management at lanx entertained him as the director of sales . BTW did you see the picture of JOE Pryan in the followers section, he does look like Jenner.....
DeleteThe Dirk Kuyper path of destruction continues...he runs the SVP of HR out the door and after making another bad hire in the SVP of Marketing, that guy saw his last day today too. Nice work, when will we get some relief?
ReplyDeleteYou are owned by Healthpoint Capital, there is no relief in sight. Psychopaths and Sociopaths, a great combination. RIP Alpha Wreck
DeleteI thought Dirk was run out the door? Sorry, 6:06 PM. That place is just toxic. For ATEC to survive, they will have to remove most of the Sr. Management. They spew nasty, radioactive poison 24/7. All those around them become ill and then spread it too. You should just leave, or else you will catch this awful cancer and spread it to your friends and family. There are far, far better places to work.
DeleteDoes SL take any of the blame for sales?
DeleteOh no, not the SVP of HR!! Where will you run to for extra sick days and the early excuse slips to leave work when you have menstrual cramps?
DeleteAnyone here work with the NE VP? BDR??
DeleteJP your day is a coming!!!! Save up kiddo.
ReplyDeleteShame on you. JP Timm is the best product guy in the business. Brilliant and innovative, Alphatec should keep him forever and ever. In fact, they should make him the new CEO so he can bring his genius to the whole organization.
Delete8:23
DeleteYour kidding right? Puff puff give. Perhaps Jens is descent at licensing but far from best product guy.
Doesn't it make sense that they pull their PEEK cages off the market then. I mean, what with this amazing product they have why don't they convert their surgeons over to SiN.
ReplyDeleteUm, yeah... lmao
Smoke and mirrors... buy us for our IP but don't look at how much of our sales come from that... that's no matter!
Keep moving keep moving... have you seen our factory?
Plastic is dead. Use it only when you need to respond to RFPs at $1000 a cage. When you want someone to heal reach for silicon nitride. This stuff is the real deal. Amedica has been a good company to work with. NASS will be real interesting.
ReplyDeleteYou guys are pathetic. SiNi is not nearly as good as PEEK or Titanium. SiNi has no future as an interbody material. I would bet your sales are far less than even the smallest spine companies. You guys should try to make something from the US Spine products you bought. SiNi is BS. Seriously.
DeleteAmedica folks are incorrigible.
DeleteAmedica a good company to work with??? Really??? I was a distributor, and they arrogantly broke my contract. They will step on anyone to make a dollar. They are very desperate!
Delete3:04 if you were canned it was because you were an underperforming distributor. Learn to sell something and keep a job. And by the way don't call yourself a distributor if you are the only person in your company. You are a Rep who wants to be over paid with no intention of being a good business partner and investing in your business. Jerk.
Delete3:04 sounds like a manager talking..correct? I have a few friend let go by Amedica. Granted, some for non-performance, but let's be fair..the manger must accept some responsibility for that failure too. Manger's are quick to want to accept praise when things go well in their area, but must also accept blame when things do not. A few distributors were let go due to the merger with US Spine. Amedica was in a spot where they had two contracts with distributors for the same geography, but made a decision to not honor one of those agreements.
DeleteI'd suggest some professionalism training for you. Clearly, 3:04 was expressing their opinion based on how Amedica treated them. You on the other hand are making a bunch of assumptions that they were under performing, and that they are not, or do not know how to run a distributorship. Take a long look at yourself as you are not in main stream sales..you are a manger of some type. I'd surmise you are the Jerk my friend. Spinal Implant Sales 101 should be available for you. Good luck with your training.
Incorrect Pansy. Not a manager at all but rather a rep who works in a fantastic distributor organization. I agree under performing reps, distributors and corp. managers must all be accountable for results. If you had a "few friends" fired by Amedica it is because they stunk as salesman. I have never known a company to get rid of producers. If some formerly worked for US Spine and were not retained at the acquisition it is because they stunk (not selling enough facet staple guns I guess…). And it was an acquisition not a "merger". Amedica bought US Spine.
Delete"Clearly, 304 was expressing...treated them." What? 304 was not a producer. The spine business is not a welfare industry. It is not always the other guys fault. Be accountable. Get results and survive. 304 needed to hear some direct analysis of his situation. Maybe he will toughen up and learn from his mistakes or maybe not. But the bottom line is this; I wish more reps like 304 existed in my territory so I could eat his lunch.
PS- I took Spine 101 when you were still trying to get date to the Sadie Hawkins Dance in Middle School. Pansy
7:32 - I've been in this industry for 14 years now. Your comments although not very well thought out..are funny! I love guys like you.."know it all's". You're quick to spount off, but you could be missing the larger, behind the scenes dealings that go on. I was corporate with SD then becoming MSD, and you'd be shocked how decisions are made. Amedica is no different. They do what is best for the company, and are less concerned with any sales rep, or distributor. Your comments come off as immature at best. Lighten up Francis!
DeleteYou expect NASS to mean anything? Let me picture it... Surgeons stampeding Amedica's oversized booth to gawk at implants based on 2 small studies done in petri dishes and rats showing anti-bacterial properties?? The claims of faster fusion on your website are a stretch given you still have not published any clinical papers to support this statement. Do you really expect surgeons to be this gullible??
ReplyDeleteZimmer is on the move!!!!
ReplyDeleteZimmer on the move..chasing their tails..again. Zimmer is a joke!
DeleteYeah - moving down again!
DeleteIf anybody can do it, Paul can. Great leader and SYK crumbled after he left. Just wondering why he likes the repair jobs.
ReplyDeleteThat's why the company is imploding around him and laying off people left and right. How did his hand picked AVP for the West work out? That's right, he was let go for falsifying expenses just like at Stryker. He has run the company into the ground and they have screwed the pooch on the last 2 acquisitions. What makes anyone think they will turn it around? Zimmer is DOA and that is why every recruiter will tell you they have a desk full of Zimmer resumes.
DeleteThanks Paul? Stryker crumbled after he left? you are funny LOL Haven't seen weezy walk on water yet
ReplyDeleteHe turned a cowpie into a respectable name with 2nd rate implants, sort of what Zimmer needs.
ReplyDeleteZimmer will have to make an acquisition to modernize their product line, otherwise even Paul G can't save them. The products in the pipeline will launch obsolete, because they are just responding (very lately) to the perceptions of their sales leadership team. Instead of leading, they are following very, very slowly. Great folks, just a risk adverse culture. Most of the large companies have this disease, and will have to acquire to thrive.
ReplyDeleteThis comment has been removed by a blog administrator.
ReplyDeleteNice of them to offer internet access at your psychiatric facility
ReplyDeleteThis comment has been removed by a blog administrator.
DeleteSorry Bally, 4:42 PM is right. 2:11 PM is wrong about most of it, and seems to be smoking something quite powerful. Kind of kumbaya... And you sir, 5:35 PM: You must shop at the same head shop. Try oil and gas for fines. They are fined more in a few days than the entire med device market since the beginning of time. Duh...
DeleteThis comment has been removed by a blog administrator.
DeleteWe should all fold up our tents and go home. Bally is the ONLY person who lives an ethical and moral life. We should all emulate her existence. Too bad we all were not born in to a family of wealth and provided an ultra liberal left wing education and a secured job in the family business when we got out.
ReplyDeleteLiberals love to tell everyone else how to live!
Liberalism, ideas so good they have to be mandatory!
DeleteJust look at Wisconsin, give the people a choice and more than half of them walk away (from mandatory union fees).
Is this the best you CONS can do?
DeleteYour industry is the most fined, most sued and the most investigated of any industry ever. That's the truth and all you jokers have are insults. Kill the messenger if you don't like the message?
Ballywho?September 23, 2012 1:07 PM Said,"Too bad we all were not born in to a family of wealth and provided an ultra liberal left wing education and a secured job in the family business when we got out."
Sounds like you are talking about Mitt Romney?
This is not about left or right. Chuck Grassely a Republican Senator has investigated your industry. If you guys were an ethical and law abiding industry there would not be so many lawsuits, fines and investigations. You are defending the indefensible and you are doing a lousy job of it.
Can you name another industry besides big pharma that is as corrupt as your industry?
I guess when truth and logic fail the shills they will try to make it about politics to change the subject. How about we bring religion into it next?
Try the eight commandment on for size. "Thou shall not steal."
The fringe right, Santorum telling everyone how they should behave in their own bedroom, what God they should worship, abortion should be illegal, planned parenthood is a communist organization, etc., oh and by the way, that I should believe in false gods, tell me who's telling who just how they should live. Less government by the right only pertains to people of entitlement, do you people understand how ridiculous you sound, telling your own voters that Obama and the liberals are elite intellectuals, so aren't you implying that the people you are speaking to are sheep? Keep drinking the kool aid. We'll see who wins on election day, that's why they play the game. Talk is cheap. When serving your country becomes mandatory, like in Israel, then we will really find out how the hawkish right really feels. When you tee it up this afternoon, remember who takes care of your golf course.
ReplyDeleteSo you just lumped the fringe right into the entire right? Talk IS cheap and your El presidente has filled all of us with enough of it to last through our grand kids life time. I don't golf but have worked my way up from being a caddie. Liberlas are a blight on our nation!
ReplyDeleteSantoum is fringe? If Romeny had not cheated in the primaries or if Ron Paul were not running Santorum would be your man. At least Rick Santorum has a core.
DeleteSantorum is scary. He would like to take America back to the Middle Ages, when the white man still had to appear on the scene. Please keep Sanctimonious contained.
DeleteSantorum is a flake but he had a ton of support.
DeleteSo the Fall show season is upon us,, Any good gossip or rumors come out of SMISS this past weekend?
ReplyDeleteBuzz wuz the Fortune Mag article on Norian. And how Synthes sales representatives mocked Spine surgeons skills
DeleteThe spine industry is just full of classy characters. Maybe American surgeons would be better if they weren't under the lash and greedy influence of the industry. There are probably many many American surgeons who would love to have the tools and training that European surgeons have.
DeleteI guess it is easier to blame the surgeon when the tools they are given are junk.
Your uncle Ted Kaczynski would be especially proud of your psychotic, bitter anti-establishment paranoia.
ReplyDeleteDo you have a manifesto too? TSB might be a good venue for publication. Go ahead, humor us punk.
Here is my manifesto:
DeleteHippocratic Oath: Modern Version
I swear to fulfill, to the best of my ability and judgment, this covenant:
I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.
I will apply, for the benefit of the sick, all measures [that] are required, avoiding those twin traps of overtreatment and therapeutic nihilism.
I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon's knife or the chemist's drug.
I will not be ashamed to say "I know not," nor will I fail to call in my colleagues when the skills of another are needed for a patient's recovery.
I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God.
I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person's family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick.
I will prevent disease whenever I can, for prevention is preferable to cure.
I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.
If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.
Maybe you industry shills should read it. Radical huh? Hippocrates the father of medicine must have been a real left wing loon. I guess the idea of putting patients before obscene profits is also a radical socialist idea.
Just one question that you won't answer. What price do you shills put in the lives and safety of patients?
You shills cannot defend what your industry does so you toss out insults. That's all you have. When you salesman get laid off because your company screws up I am sure you will figure out a way to blame the president and the Affordable Care Act and you may have a point because more and more industry fraud is being uncovered and that mean less money for the industry and their errand boys.
Do any of you care about patients even a little?
Oh, so you're a physician then right?
ReplyDeleteAnonymousSeptember 24, 2012 9:19 PM Said "Oh, so you're a physician then right?"
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Why would you ask that?
BTW, what do you think of the Hippocratic Oath? Do you think it would be a good guide for the now unethical device industry?
"Bally"-
DeleteYou. Have. A. Mental. Disease.
Time at last for you to face it.
Do yourself a favor a recognize it. Start TODAY. Make the changes that are needed. Recognition is the first step in the process. Start helping yourself, by stopping posting here and other places.
"Obsessive compulsive personality disorder - there is excessive concern with perfectionism and work at the expense of close personal relationships. The individual is INFLEXIBLE and feels an overwhelming need to be in CONTROL. Concerns about rules and efficiency undermine the individual's ability to relax. Others may see them as SANCTIMONIOUs, uncooperative, OBSTINATE, and miserly.
People with an obsessive compulsive personality disorder are WORRIED about issues that appear out of control or messy. They are typically workaholics, are interested in lists and timetables, and have trouble completing tasks because they have to be so perfectly done. Opinions on lifestyle issues, such as ETHICS, morals and religion are usually extremely RIGID."
Its pretty obvious to everyone here.
DiFusion press release tonight. "Our clinical tests have shown repeatedly that we have a new biomaterial which eradicates MRSA bacterium 99.998%," says Joseph Crudden, PhD, Vice President of Research at DiFusion.
ReplyDeleteThis is the problem with these companies making these antimicrobial claims. You need big studies to support these claims. DiFusion is to be commended for doing a 10,000 patient *clinical* study and only seeing 2 infections. And that they did that type of study multiple times e.g. repeatedly. I'm really, really impressed that they did a study appropriately powered to make such a claim.
http://www.businesswire.com/news/home/20101007006503/en/DiFUSION-Technologies-Completes-Successful-Antimicrobial-Implant-Animal
DeleteIt's nice to hear some good news for a change. The next question is, will this ever reach the US market or will it get squelched for American use?
CleanFUZE is a good thing but it is not rocket science. It uses silver as its antimicrobial and it has been know for a very long time that silver kills most bacteria. Silver in colloidal form is a very good antibiotic and very safe.
ReplyDeleteAnd what is the infection rate in Spine surgery Bally? What is the morbidity/ mortality associated with infections?
DeleteYou clearly are in the tank! Did you know the company charges a premium for their product? So they can make profits Bally, money, greenbacks! Evil!
There are people who create and build in this world. That takes energy, positive energy. And then there are those who destroy and tear down because it is easy and takes less energy. That is you. A non contributor. Your Alma Mater would be proud.
Take the obvious time on your hands and go out and create something Bally instead of typing away in your Occupy tent. Build something and stop being such a whiny twit bashing everybody on this site. This is not your site btw.
Most of them are hard working people who raise families, pay taxes, donate money, volunteer and build up their communities.
btw...I just got home from seeing a patient who received a 2 level ACDF 3 months ago. She had tears in her eyes b/c she was so happy that her pain was gone. She can play with her grand kids again. Her life is better now.
Damn I am such a bastard!
AnonymousSeptember 25, 2012 3:17 PM Said
DeleteAnd what is the infection rate in Spine surgery Bally? What is the morbidity/ mortality associated with infections?
You clearly are in the tank! Did you know the company charges a premium for their product? So they can make profits Bally, money, greenbacks! Evil!
There are people who create and build in this world. That takes energy, positive energy. And then there are those who destroy and tear down because it is easy and takes less energy. That is you. A non contributor. Your Alma Mater would be proud.
Take the obvious time on your hands and go out and create something Bally instead of typing away in your Occupy tent. Build something and stop being such a whiny twit bashing everybody on this site. This is not your site btw.
Most of them are hard working people who raise families, pay taxes, donate money, volunteer and build up their communities.
btw...I just got home from seeing a patient who received a 2 level ACDF 3 months ago. She had tears in her eyes b/c she was so happy that her pain was gone. She can play with her grand kids again. Her life is better now.
Damn I am such a bastard!
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According to a variety of large published studies, post-operative surgical site infections (SSIs) occur in up to 20% of patients costing the U.S. health care system billions of dollars annually. In fact, a single SSI can cost up to $100,000 per incident and result in significant injury, disability or even death. Complicating the problem of SSIs is growth in the number of antibiotic resistant bacterial strains such as MRSA, which are associated with rising infection rates in hospitals. With few available treatment options hospitals, surgeons and payers have shifted their focus toward new methods of prevention as an essential tool to avoid SSIs.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC23141723/
Now you are trying to paint me as an anti capitalist. I most be an ultra liberal for believing that medical ethics is a good thing and greed is a bad thing.
There are people who create and build in this world but when they do within the Spine industry they can only sell their products outside the US. I have a ADR design. I have built many things.
ACDF has a 50% success rate so the act that you found a woman who was lucky enough to find a skilled US surgeon. Your industry does not deserve credit the surgeon does.
Once again all you CONS can do is ignore the facts. The fact is your industry stinks for the most part. There is little innovation and when a company gets creative and makes something remarkable you corporatist cons talk shit.
It looks to me that this industry hates innovation and competition. Companies like Amedica and DiFUSION are the movers and shakers and you guys who are selling obsolete hardware and other tinker toys are going to be left in the dust. Lean and mean companies are going to knock the corporate geezers out of the game. You don't want capitalism because when innovation and competition come along you fake conservatives cry for corporate socialism and corporate welfare ie the bank bailouts. There is a new sheriff in town and he's cracking down on the fraud and abuse. Now you CONS have another reason to hate Obama, he's making you corporate gangster play by the rules. COOL HUH?
Now when hospitals infect patients they don't get paid.
Hasn't titanium already been proven to be bio-friendly, anti-microbial as well as a material that encourages bone to grow around it, for years, clinically?!
ReplyDeleteAre these ridiculous two lab studies relevant at all!? Seems like to me they are as apt to be published in MAD comics as in any relevant medical journal.
In reading them it seems to have more to do with the micro roughended surface than with the chemistry of the implant. Again, couldn't PEEK or Ti be given a similar surface if in fact infections were actually a problem?
Amedica -less Sendro- are a joke.
The short answer is no. It's not a coating. Silver is infused into the PEEK material and it leaches out for 6 weeks. That is what kills the bacteria.
DeleteThe studies are for real and cleanFUZE will have the CE Mark by 2013 and FDA approval by 2014. It will make all other cages obsolete.
DiFusion will be using this technology in their other products to stop SSIs. it was 99.99% effective in animal studies.
Derrick Johns sounds like an ethical man who knows how to get things done. I think that we will be seeing some innovation and finally some real science.
Read this and weep.....
DiFUSION’s recently completed third party animal tests showed that after introducing Methicillin Resistant Staphylococcus Aureus (MRSA), a common, aggressive, multi-drug resistant bacterium, to rabbits implanted with DiFUSION’s proprietary CleanFUZE orthobiologic polymer, the animals showed little visible inflammation or infection. Microscopic analysis of the same samples showed CleanFUZE to be up to 99.99% effective in eradicating the active infection.
"This is the first time any potential biomaterial has shown, in an animal model, to significantly reduce the numbers of an infectious agent as well as the local tissue markers of actual infection,” said Matthew Geck, M.D., cofounder of DiFUSION. “This was done using a safe and tissue friendly, pharmacologic dosing of silver with our innovative and proprietary biomaterial that combines the structural properties of PEEK with the controlled elution of cationic silver. This biomaterial has the potential to be the base material for a whole range of spine and orthopedic implants."
According to a variety of large published studies, post-operative surgical site infections (SSIs) occur in up to 20% of patients costing the U.S. health care system billions of dollars annually. In fact, a single SSI can cost up to $100,000 per incident and result in significant injury, disability or even death. Complicating the problem of SSIs is growth in the number of antibiotic resistant bacterial strains such as MRSA, which are associated with rising infection rates in hospitals. With few available treatment options hospitals, surgeons and payers have shifted their focus toward new methods of prevention as an essential tool to avoid SSIs.
“The results from the in vivo animal testing are very encouraging,” remarked Gary Ghiselli, MD, chairman of the DiFUSION scientific advisory board. “They represent a big step towards establishing the ability of CleanFUZE to reduce, and possibly eliminate, the incidence of post-operative surgical infections. This has obvious wide-reaching potential in spinal surgery and in orthopedics in general, to reduce complications and improve patient outcomes.”
The incidence of infection is about 0.01%, so this is a waste of time is it not?
DeleteAnonymousSeptember 25, 2012 12:35 AM
DeleteHasn't titanium already been proven to be bio-friendly, anti-microbial as well as a material that encourages bone to grow around it, for years, clinically?!
Are these ridiculous two lab studies relevant at all!? Seems like to me they are as apt to be published in MAD comics as in any relevant medical journal.
In reading them it seems to have more to do with the micro roughended surface than with the chemistry of the implant. Again, couldn't PEEK or Ti be given a similar surface if in fact infections were actually a problem?
Amedica -less Sendro- are a joke.
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Titanium is toxic and 13 studies say so. http://health.consumercide.com/dent-toxtitanium.html
According to a variety of large published studies, post-operative surgical site infections (SSIs) occur in up to 20% of patients costing the U.S. health care system billions of dollars annually. In fact, a single SSI can cost up to $100,000 per incident and result in significant injury, disability or even death. Complicating the problem of SSIs is growth in the number of antibiotic resistant bacterial strains such as MRSA, which are associated with rising infection rates in hospitals. With few available treatment options hospitals, surgeons and payers have shifted their focus toward new methods of prevention as an essential tool to avoid SSIs.
http://www.businesswire.com/news/home/20101007006503/en/DiFUSION-Technologies-Completes-Successful-Antimicrobial-Implant-Animal
DiFUSION’s polymer is a blend of a cationic matrix which carries pure silver, an effective broad spectrum antimicrobial, and a PEEK polymer which are combined through a proprietary process to create CleanFUZE. The resulting material can be used to create a variety of orthopedic devices that release silver ions into the surrounding tissue, allowing for controlled, continual dosing over a four to six week timeframe, resulting in significantly increased efficacy.
“CleanFUZE orthobiologic PEEK is a self-sterilizing polymer which this study has shown to be up to 99.99% effective in eliminating post operative infection,” said John Kaelblein, President of DiFUSION. “CleanFUZE could have a real impact on patients and the healthcare system in general. These results represent a huge step toward bringing CleanFUZE to market."
More metal toxicity.... https://www.mja.com.au/journal/2011/194/12/cobalt-toxicity-emerging-clinical-problem-patients-metal-metal-hip-prostheses
Hey, I've got a great idea... let's create a PEEK interbody device that leaches toxic silver nanoparticles directly into the spine!!!
ReplyDeleteOOPS!
Aren't JNJ and the others reserving billions of dollars every quarter to settle lawsuits due to metallic nanoparticles? Oh, but you claim silver isn't toxic? Read:
Exposure to silver nanoparticles has been associated with "inflammatory, oxidative, genotoxic, and cytotoxic consequences"; the silver particulates primarily accumulate in the liver.[1] but have also been shown to be toxic in other organs including the brain.[2]
1.^ Johnston HJ, Hutchison G, Christensen FM, Peters S, Hankin S, Stone V (April 2010). "A review of the in vivo and in vitro toxicity of silver and gold particulates: particle attributes and biological mechanisms responsible for the observed toxicity". Crit. Rev. Toxicol. 40 (4): 328–46. doi:10.3109/10408440903453074. PMID 20128631.
2.^ Ahamed M, Alsalhi MS, Siddiqui MK (December 2010). "Silver nanoparticle applications and human health". Clin. Chim. Acta 411 (23–24): 1841–8. doi:10.1016/j.cca.2010.08.016. PMID 20719239.
Now THAT is what I want leaching into my spine!!!
Good luck with that, boys!!!
Look like another salesman is running scared and posting misinformation.
DeleteSilver is a safe antibiotic. There is also not enough silver in it to overdose anyone. Sliver is non toxic. We do know that cobalt and titanium are highly toxic and allergenic.
The amount of silver is tiny and it dissipates after 6 weeks. There can be no toxicity. People who where silver jewelry or have silver fillings absorb probably 100 times more silver.
Nice try but it won't do you any good. DiFUSION has a superior product that will eliminate nearly surgical site infections making every other PEEK cage obsolete. Don't feel too bad, maybe you can still sell screws, swivels and brackets at True Value Hardware.
Topical use only you mental midget.
DeleteBally Balldez,
Delete4:35 stated an objection and backed it up with white papers and data that are less than two years old saying that in fact silver nanoparticles are toxic and cause negative outcomes. Instead of spouting off and talking out of your ass, why don't you offer some data that refutes his/her claim? Maybe you need to get that GED, yourself!
This blog seems to be populated by Amedica and DiFusion reps! Improving patient outcomes and reducing infection rates are great ideas... Can't that be accomplished without toxic substances leaching into the human body?!?!?
ReplyDeleteNASS is upon us... Question: What is the coolest event or idea for a party a company could host to get distributors' attention and induce them and sales reps to attend?!?!?!?!?
In reply to your question regarding "what is the coolest event or idea for a party a company could host to get distributors' attention and induce them and sales reps to attend"......it's a simple answer!
DeleteAn exciting, innovative product that positively affects the spine community in a positive manner.
Not with this lot....it'll be money...offer them money
DeleteSilver is not toxic and you know it. Dental filling have been made from silver for maybe 100 years.
DeleteYou reps also know that because of DiFUSION'S innovation and superior product line a lot of you will be looking for work. Good luck with that. I hear that Walmart is hiring.
Now I am being accused of working for DiFUSION. LOL! Such paranoia. Don't worry peasants your masters will work hard to keep this out of the North American market. You will still be able to sell nuts and bolts, brackets, swivels, screws and glue at least for a while. It won't be in the US until 2014.
I have a question for the reps <:-( here. Why do your companies hire so many salesman who don't even have GEDs? Just askin.
http://www.nanowerk.com/news2/newsid=26798.php
Delete"Subsequent studies, however, demonstrated that at the concentrations required for killing bacteria, the silver ions also damaged fibroblasts to a significant degree.
“We hadn’t expected this to be the case, of course, given that silver is already widely used throughout medicine,” said Barcikowski, Chair of Technical Chemistry I at the UDE and editor-in-chief of the journal BioNanoMaterials.
“But further testing proved that it was the ions themselves that were damaging the cells and not, as we had at first suspected, the synthetic materials.”
When the scientists then mixed the samples with albumin, silver’s antibacterial effectiveness dropped, but the damaging effect on the cells remained the same.
The therapeutic margin is therefore extremely narrow in this case, making medical applications risky ("Therapeutic Window of Ligand-Free Silver Nanoparticles in Agar-Embedded and Colloidal State: In Vitro Bactericidal Effects and Cytotoxicity").
The silver is gone in 6 weeks so your point is moot even if there is some truth to it.
DeleteSubstances which inhibit cellular growth such as silver and most antibiotics will also inhibit osteoblasts and fusion. That's why this technology should never be used with fusion implants. Unfortunately this fact of cellular biology seems to be lost on these folks. Fortunately, most venture capitalists don't know cellular biology, so they are throwing money at this doomed idea.
ReplyDeleteAnonymousSeptember 25, 2012 5:06 AM said:
Delete"Substances which inhibit cellular growth such as silver and most antibiotics will also inhibit osteoblasts and fusion. That's why this technology should never be used with fusion implants. Unfortunately this fact of cellular biology seems to be lost on these folks. Fortunately, most venture capitalists don't know cellular biology, so they are throwing money at this doomed idea."
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It's Bill Ney the Science guy.
Sorry but silver does not inhibit bone growth. The research staff's credentials are impressive to say the least. What does inhibit bone growth are infections.
Keep dreaming and fooling yourself but let's say that your are correct and the tiny amount of silver can inhibit fusion. The silver is gone in 6 weeks.
Silver cures MRSA infections, purifies water, destroys candida and fights off chronic diseases like cancer, osteoporosis, mental disorders and more.
Now for the science... http://connection.ebscohost.com/c/articles/28652688/influence-elementary-silver-versus-titanium-osteoblasts-behaviour-vitro-using-human-osteosarcoma-cell-lines
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1920591/
DiFusion was not started by vulture capitalists. It was started by a war hero, scientists and doctors aka smart people with integrity.
So please go chew a fistful of dimes to cure the MRSA that is slowly chewing your brain into mush!
DeleteThis comment has been removed by a blog administrator.
Delete"Antibacterial effects occurred at Ag(+) concentrations that were 2-4 times higher than those inducing cytotoxic effects. Such adverse effects on OB and OC survival may have deleterious effects on the biocompatibility of orthopaedic implants."
DeleteDepartment of Clinical Research , Group for Bone Biology and Orthopedic Research, University of Bern, Bern , Switzerland.
Look it up, Bally Ballsucker!
I tried this product for two cases. On my second case, the back of the implant broke off where you clamp down on it. No way to remove or readjust it at that point.
ReplyDeleteAt least with PEEK, I could comfortably burr it out w/o having increased concerns about the particles.
It has been 10 days since this post has started. Did MSM go on vacation or is it that there simply is nothing "new" or worth talking about in spine?
ReplyDeleteAny updates on the DePuy Synthes Spine implant machines in substerile? How about Globus surgeons reaction to going public? Are they still using the crap? What's going on at Stryker? Is Nuvasive working with any "new" surgeons or is it just the same ole, same ole. Is K2M making a dent anywhere? What about the $200 Korean pedicle screw? Topics anyone??
Who here is sick and tired of hearing Bally Baldez thinking he/she/shit has to respond to every post and shit on our industry? Please stop the madness and STOP responding to his/her/sharts comments.
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DeleteBally Who? 4:35 stated an objection and backed it up with white papers and data that are less than two years old saying that in fact silver nanoparticles are toxic and cause negative outcomes. Instead of spouting off and talking out of your ass, why don't you offer some data that refutes his/her claim? Maybe you need to get that GED, yourself! DiFusion or ConFusion?
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DeleteYou are sick, face it. Go away, get help for your problem? Stop posting as the first step of your treatment.
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DeleteThis topic has received nearly twice as many comments as the average post on this blog, which tells me MSM has clearly touched a nerve. I'm not sure I understand why so many people want to throw Amedica under the bus, but it sure seems that if they're right, their technology will disrupt the status quo in dramatic fashion. What I don't understand is why Amedica doesn't follow Invibio's model and make silicon nitride for everyone. Why create a brand when, if you have the goods, you could make it for Stryker, Synthes, Zimmer and the rest and kick PEEK to the curb in about two years.
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DeleteGo away, "Bally".
ReplyDeleteYou're sick. Get help.
Really, go away. It'll be sooner that you'll get better, and the rest of us have better things to discuss than to feed your personal inadaquacies. Go away. Get help.
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Delete624 good point. Does anyone at America have comment?
ReplyDeleteInnovation? Phygen? Autolock...? Look at their website. Interesting...!
ReplyDeleteNo its not!
Delete199. Almost to 200.
ReplyDelete200 !!!
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