Monday, September 20, 2010
Is There Anything New and Innovative In Spine?
With the impending Second Annual Spine Technology Awards, its that time again. Albeit, this venue is a step down from San Francisco. There'll be no red carpets. No Hollywood Starlets, it seems Lindsay Lohan will be unavailable by this Friday. TSB wants to know what our readers think is a new and innovative technology? Is there anything new and worthwhile to spend another few hours commiserating with some of the high powered rollers in the industry? Will there be a new emcee, or will we hear the same old same old. For these prices, the least Robin could do is perform a soft shoe. Will Robin kiss Hansen's ring? Genuflect when Hochshuler (aka Hyman Roth) enters the room? Tell us for the 99th time about his good friend Tony V? Who knows maybe Nucky Thompson will make a guest appearance. At least if Nucky appears, he could address the audience like we are all at a temperance meeting. Log on to the OTW website and get your tickets while the last. And remember what Nucky said, "never let the truth get in the way of a good story." TSB wants to know who's in and who's out?
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Baxano..... no
ReplyDeletesilicon nitride
ReplyDeleteFACETFUSE ROCKS!!! Booyah
ReplyDeleteMedtronic's Solera Pedicle Screw
ReplyDelete2nd Generation ISP devices.
ReplyDeletechipotle came out with a new type of burrito that's pretty good.
ReplyDeleteBiologics. Pure and Simple
ReplyDeleteI am for the burrito!
ReplyDeleteSecond the motion: Silicon Nitride. Bony on-growth. Game over.
ReplyDeleteI don't get why people think this silicon nitride stuff is so revolutionary. Bony on-growth? Big deal! Zimmer's trabecular metal allows for bony on-growth. That wasn't a game changer, and your beloved pipe-dream, Silicon Nitride, won't be either. How about some TRUE INNOVATION? Come on people!!
ReplyDeleteBTW morons - when referencing silicon nitride it's bony IN growth ... bony ON growth refers to HA coatings but I agree that the silicon nitride implants from Amedica are way too stiff. The only docs I see using them are getting paid or were fellows in Utah.
ReplyDeletesilicon nitride is a different material compared to trabecular metal especially in imaging.
ReplyDeletestryker came out with new golf memberships didn't they ? that's not innovative but dangerously effective.
Actually, moron, "bony on-growth" and "bony in-growth" are both industry manufactured terms so it's a moot point. Nice try though!
ReplyDeleteAnyway, back to the point...where's the innovation?? Robo-spine anyone?
-The Rationalist
1) how about bony attachment vs. fiberous encapulation...
ReplyDelete2) Zimmer's is like trying to access fusion with a CT/MRI that looks like Haley's Comet
3) SiN allows for assessment of fusion w/out scatter/artifact/halo, etc.
4) Apparently you have lost business to Amedica and are making up stuff to bolster your ego. To which, I say, whatever.
Silicon Nitride is a questionable material in my opinion. There is one characteristic that everyone seems to be forgetting.....it's very brittle. If it were impacted at the slightest angle, and with an instrument without a nylon tip to absorb the impact energy, it is definitely subject to cracking and overall damage to its structural integrity. This information can be found in several studies which address the mechanical properties of Silicon Nitride.
ReplyDeleteI heard one of their company reps state one time that you could stack 14 Toyotas on top of a single interbody spacer. That may be true, but it does not address the sudden impact of a surgical mallet whacking on a tamp that could be off-center. My bet is that there will be some problems with breakage.
Anonymous 8:44,
ReplyDeleteLost business to Amedica? Haha...who is losing business to peanut-brittle nitride? Furthermore, what makes you think that I am even a rep? Can we please get back to the post? Who's got something innovative? What's the next "big thing"?
Yeah anonymous 8:44, shut-up about your sh*tty silicon nitride. Nobody has lost any business to you. We're just tired of hearing about it.
ReplyDeleteIts official, Amedica has acquired US Spine.
ReplyDeletehttp://www.amedicacorp.com/company/news/09.20.10.pdf
Good thing their booths are right next to each other at NASS...
What about this Trinity Evolution stem cell product? Is this truly innovative or a spin on something old??
ReplyDeleteI heard that US Spine's entire location is going to be closed. What did Amedica actually buy? The press release says screws, and facets, but Distribution?
ReplyDeleteHey, 8:44... You wrote that Silicon Nitride is brittle? Are you an idiot? The US Army and Marines use SiN in body armor to STOP BULLETS! NASA uses SiN ball bearings in thr shuttle program. SiN doesn't fracture or splinter and it certainly isn't brittle! Every Amedica SiN device is torqued, proofed and stress tested to a level that would crush all the bone around the device and the material still won't break.
ReplyDeleteSo, are you a disgruntled employee, a competitor or, simply, a moron?
Which ever you are, your agenda is transparent! Get a life!
Any other new technologies worth looking out for at NASS?
ReplyDeleteTrinity Evolution!?! Heh.
ReplyDeleteI second the Solera. What about iFuse??
If I were a surgeon that is exactly what I would want to use in the disc space. A material that is harder than everything that surrounds it. That way my patient comes back to me with implant subsidence and I get to do an adjacent segment. NOT!!!!
ReplyDeleteLet me lay it out for you in terms a 3 yr old could understand.
1. Place a Steel ball-bearing between two pieces of glass
2. Place axial load on that structure.
3. 7:04 Get back to me with the results.
This material will never gain widespread acceptance and that's all she wrote.
Someone posted 2nd Gen ISP Devices - like what? A better SP fusion plate? Yet another SP spacer?
ReplyDelete8:05 you are a complete moron, how did you get into this industry? Clearly, you don't have a clue. you should go back to high school and take physics, chemistry, and bio all over again. you sound like an idiot.
ReplyDeleteAnyways, can we talk about someone else?!? Amedica reps- your docs aren't reading this site.
So Synthes is skipping NASS?? what about their gamechanging technology called Matrix--
hahahahaaaaaaaa synthes is a joke.
Amedica's cage is hydrophyllic....another feature PEEK doesn't have.
ReplyDeleteFace it. Goodbye to PEEK.
The only surgeons that won't jump all over this technology are the ones getting paid by other companies....
And you though innovation was slowed down by technology.
Not new, but maybe a positive iteration on the existing - what about Cortoss from Orthovita???
ReplyDeleteand Hydrophilicity is a feature because...?
ReplyDeletemaybe these cages dissolve...!
Any insight on stem cell products???
ReplyDeleteTwenty-nine comments in and I think I need some help here.
ReplyDeleteSpecifically, what is the current definition of 'innovative' in spine technology? The comments thus far, while humorous, are largely uninspired.
Below are a few jumping off points to rekindle the mosh-pit commentary I have so learned to love:
1. Makes meaningful, clinically proven impact on the treatment of spinal pathology and assists surgeons to provide better outcomes and quality of life for their patients.
2. Is approvable.
3. Is reimbursable.
4. Allows me to continue to generate commissions and comp that rival attorneys, doctors and lower tier professional athletes.
5. All of the above (?)
What is so innovative about Solera? Smaller rod, but nearly the same sized screw head. RFID tags, ummm BFD. OsteoGrip thread pattern looks OK but I haven't seen anything that actually proves better pull out strength. I don't get it. The trays are really nice though!
ReplyDeleteThere is some promise in stem celss, I think. The problem with some products is they are harvested from cadavers so you have no way to know if the cells are viable. Generally speaking, most donors are old (not with all tissue banks) and stem cell counts dwindle as you age. The cells are then stored at -80C and have a 5 year shelf life. True cryopreservation requires close to -200C to "suspend" the cells, at -80 they still have some activity and will degrade fairly rapidly. Osteocel and Trinity deliver a large number of cells, but they don't claim they are all stem cells, and they don't claim they are all viable, so what are you really getting.
ReplyDeleteStem cell products from healthy living donors, collected in a controlled fashion and cryopreserved is the only way to know you are getting viable cells in the OR.
The goal of all bone grafting is to get mature osteoblasts laying down new bone. Stem cells are he most direct way to get those, but you still need a signal (BMP, but not an atomic bomb of a signal like Infuse) and a scaffold (anything probably works including cancellous bone or DBM)
There are some coming out, keep your eyes peeled.
4. Allows me to continue to generate commissions and comp that rival attorneys, doctors and lower tier professional athletes.
ReplyDelete--- This is what makes a product new and innovative!? Was that just a red herring, or something to spark further comment?
I love the constant drill down into the minutae of the "stem cell" technologies on the assumption that they're magically useful!
ReplyDeleteAre more cells better?
Which are the right cells?
Who are the right donors, and shouldn't they be crossmatched to recipient?
I sure as Hell don't want someone else's living cells in me, why is it that so many people seem to think this is a good idea?
Where is there even a speck of evidence that these "products" provide a clinical benefit, or that they're safe?
I see this as simply an unfortunate regulatory loophole separating fools from their money. The fact that that those fools money comes from my escalating insurance premiums pisses me off!
Anonymous 11:14 - Red Herring.
ReplyDeleteThough if it proves a favorite it will have served as an insightful litmus of the reader's 'values'.
Amedica has EVEN LOWER SALES than US Spine had. They have virtually no penetration with SiN in interbody spacers. SiN is too stiff leading to stress shielding and poor fusion quality. Who cares that bone doesn't grow on PEEK? The fusion rates are awesome, and the quality of the fusion from PEEK must be superior due to the stress shielding characteristics of SiN. Remember, they used to use Titanium in spacers, but stopped due to stress shielding.
ReplyDeleteAmedica's SiN IFD is a "pig in a poke." The reality is that their technology for interbody spacers is worthless. As a wear material SiN is great in joints, but as a interbody spacer...not so much.
Who cares if their sales were lower than U.S. Spine! They've got the money in the bank! Also, go to their site and type in "modulus" under search. Think that paper may debunk your idea that the material is too stiff. Please provide your study and source for why it causes stress shielding and poor fusion quality. Why would you care about bone not growing into PEEK? Fibrous tissue growth around peek causes weaker fusion. There are plenty of studies regarding that. We're talking fusion quality added with quantity.
ReplyDeleteAnyone that says they have a 100% fusion rate is probably lying, plus how well does it fuse? I can tag 100 chicks, but I probably won't tell you how many are ugly, fat or just dirty. Sorry Anonymous PEEK guy that's threatened by new technology, get use to being disappointed! Think silicon nitride could be compared to bagging 99 hot chicks, plus your wife. Tell her I said hi!
I agree with 11:34, but what is a pig in a poke? The fact that Amedica's sales are so low means that their technology is not being adopted. Amedica will need to purchase better product technologies and a stronger portfolio than US Spine to avoid the same outcome as IST. SiN may be innovative, but it is not clinically relevant.
ReplyDeleteThere have been many millions of fusions with PEEK in hundreds of configurations over more than a decade. Modulus is clearly more critical than whether bone grows to the material. SiN is nearly 100 times more stiff than bone, or anything in the body. How many fusions have been done with SiN? Several hundred? Over what period of time? A couple of years? SiN as a interbody spacer doesn't make any sense. They would be better served to focus on hips and knees.
Whatever with Amedica... I think the Aspen by Lanx is pretty cool. StaLif was cool in it's day, and there are many copies. I think the new TLIF from Custom Spine is unique. Has anybody seen the protective neurovascular stent at Spinal Elements? That patent issued this summer. What about the Shrill Drill by joimax? What about CareFusion's Avamax?
ReplyDeleteBut is there a difference between being cool, rather than providing better clinical outcomes, besides the technologies you just named have been around for over a year, that immediately disqualifies them as being new and innovative.
ReplyDeleteDude, wake up, it's 2010! The docs already told you that Aspen is going to raise questions coding it as a "fusion" and custom spine's TLIF? Cool back in 2007 when price meant nothing. Love to see how that product has been accepted. Wait, this previous post has got to be a joke, right?
ReplyDeleteThe Emerging Technologies in Spine meeting is the brainchild of Dr. Youseff. Dr. Youssef just released a white paper regarding SiN. He had great results, no subsidence and had positive things to say about the material and bony on-growth.
ReplyDeleteWhile SiN was technically released in 2009 it's clearly getting the cool buzz these days.
Regards
...
Didn't he do a study where he took two sheets of glass
ReplyDelete1.)put a hard headed MSD rep in between,
2.)then put an axial load on it....
3.)Finally, sprayed some Windex to clean away the arrogance.
Just a little something any three year old could understand. People, make sure you keep reading emerging studies, some of the past comments are tainted with ignorance. The science appears to make sense, don't think anyone can say Youseff isn't a straight shooter.
hey amedica guys, quit giving your competition reasons why you think your product rocks,,,their going to run with it and bad mouth it no matter what... seriously you are wasting way too much time giving them info....
ReplyDeletestop...everyone knows whats about to happen to PEEK...silicon nitride is the future... everyone knows that....
soon these mdt reps will probably be repping it when they buy you out...
anyways. GLIF seems interesting.
I KNOW OF NOT ONE SURGEON THAT HAS USED THIS WITH ANY REGULARITY IN SOUTHERN CALIFORNIA. IF YOU HAVE A NAME. GIVE IT TO ME.
ReplyDeleteIT IS DOA! PEEK WITH CARBON HAS A BETTER CHANCE
Jeez,man,quit yelling. Please leave your name and sure they can send you some names. Agreed, GLIF does look interesting, curious to see how that turns out. Heard that amniotic tissue will soon be making it's way into spinal procedures, any input or information on that or is that the Alphatec stem cell product?
ReplyDeleteThe Emerging Technologies in Spine meeting is called another meeting where you "ski for free" or have a nice write-off. Surgeons love starting these meetings for themselves and their buddies with company/exhibitor assistance that returns squat to most companies. Their is minimal interaction with any exhibits and most docs return late or not at all for later sessions. We showcased once and it was a complete waste of time.
ReplyDeleteAfter reading 46 comments, it seems the consensus is "same old same old". Except, of course for the few on here that keep pitching their products. If you have to justify what you're selling to us, maybe you're the one who has doubt about your product, and simply feel you have to defend it. It's pathetic....
ReplyDeleteYoussef has his paws in a ton of things attached to his newly created "ski meeting". At least half the exhibits at the meeting were companies he consults for, works with, or has a piece of.
ReplyDeleteSyndicom - http://www.youtube.com/watch?v=c1-_dIqeU54
Alphatec will not be around much longer. They will either get acquired or go under; probably go under. Less than $2/share? When have they ever shown a profit?
ReplyDeleteAfter 51 comments its quite evident that it is the same old story line. As for SiN, time will tell, and you know what TSB says, $30 mil buys you a lot of time, if you don't buy million dollar sculptures for the foyer, lease offices for $15k per month and don't top load everyone's salaries. TSB believes that there is a place for this material in recon, but another interbody device? If it doesn't improve the outcomes who cares. So put your money where your mouth is (or your investors money) and prove it.
ReplyDeleteATEC has it's Puregen stem cell product from healthy living donors, collected in a controlled fashion and cryopreserved is the only way to know you are getting viable cells in the OR.
ReplyDeleteAmniotic tissue has already made it to spine. ATEC has a product named Aminoshield.
ReplyDeletemuscle milk has a new type of protein shake.
ReplyDeleteFirst there were innovators, then there were imitators, then there were idiots
ReplyDeleteThe most innovative thing for spine surgery this year is the "Double Down" Sandwich from Kentucky Fried Chicken...In all honesty Navigation continues to be the greatest technology for surgeon's and will continue to grow. Medtronic is light years ahead of everyone, we will see if they continue to leverage this technology.
ReplyDeleteIf you want to slow your case down to a crawl it is great technology.
ReplyDeleteYou don't need an MBA from Wharton to know that when a fanatic group of industry insiders like the TSB readers can't define innovation let alone give coherent and convincing examples, there might be a problem. Instead one of the more prolific string of commentaries on this blog reads a little like the hardware equivalent to 'Less Filling...Tastes Great'.
ReplyDeleteThe fact is, in 2010 the spine industry is starting to look like an extravagant game of musical chairs, and the lack of verifiable, marketable innovation means the music is speeding up and the chairs are going away. Many companies will survive, less will thrive and the constriction will force firms to start defining and creating real value again, aka real innovation. But my prognostication is that in the process many will be forced to find new callings outside of spine.
The markets giveth and the markets taketh.
Amen Brother. You know what Hank Williams sang;
ReplyDeleteI saw the light, I saw the light,
no more darkness, no more night
Now I'm so happy, no sorrow in sight
Praise the Lord I saw the light
Amen 7:04! I don't work for MSD but come on Amedica you have less than one percent of the market share. I am a distributor for a relatively small spine company and I cover three states. I have heard of two Neurosurgeons that have tried your product. In short I got veins in my dick bigger than you so pipe down! Your innovative offers no better reimbursement, is not faster for the surgeon to put in and offers no studies that demonstrate superior results. Good luck with that taking off.
ReplyDeleteIntrerventional Spine just released their perc. Posterior cervical system. This is the company Amedica should have bought!
ReplyDeleteTSB per 7:32PM.....
ReplyDeletewhat do you think of a perc. posterior cervical facet screw?
Interventional has some nice niche offerings, too bad their facet set is sold as a set. Hey, 7:24! You've got veins that large in your genitalia? Lay off the Cialis, Valtrex, HGHs and whatever else it is, made me laugh, though. Just what I expect from you, though.
ReplyDeleteSynthes isn't skipping NASS. You'll see them down there. They tried to put the money they normally put in the booths and instead give it to the societies to use. Good thought on the surface but not substantial enough to matter. The societies like see booths so Synthes will have booths after NASS. Matrix...we'll see.
ReplyDeleteVTI Interfuse...
ReplyDeleteTSB,
ReplyDeleteIf you are going to post song lyrics could you spice it up once in a while and pick some more contemporary tunes? Some of us readers are under the age of 100 and don't really get too excited about antiquated country music hits.
Note to readers: there is no difference in fusion rates among FDA approved materials (Titanium, PEEK, SiN...). As many of you know, the first fusion "devices" were stainless steel ball bearings. Guess what... they worked... and thus, the evolution of the fusion procedure into a multi-billion dollar industry. Titanium was next because it sounded sexier. Fusion rates? About the same. Then, some brilliant marketing guys picked up PEEK. Fusion rates? About the same. SiN fusion rates? About the same. Anyone with the slightest clue about the fusion procedure knows it's all about the "carpentry" - careful preperation of the disc space/end plates, yada, yada. All of the fancy marketing nonsense that has popped up (modulus elasticity, stress shielding, bony in/on growth, etc.)... it's all just that - marketing nonsense. Show me the clinical studies proving modulus elasticity means something to fusion rates. Show me the clinical studies addressing stress shielding. They don't exist.
ReplyDeleteI know this is old news to all my surgeon colleagues reading this blog (are there any others)? But, I thought I might try to help one or two of those young, independent thinking reps who have the misfortune of landing in our "industry of misinformation"...
Anonymous 9:10:
ReplyDeleteIt's my blog, and quite frankly if you're under the age of 100 you'll round out your sophisticated palate by not listening to Katy Perry (nice visual, no substance) or Lady Pastrami (I mean GaGa). These aren't one hit wonders, these are legends that I am quoting. Thanks for your humor, and one of these days I'll surprise you.
Youseff's paper should be taken with much skepticism. His data is not credible as he and his buddies, you know all the up-stating leading clinicians like Wang, Riew, Lieberman, Brodke to name a few, that often headline the NY Times have direct financial interest in Amedica. In fact many are investors in the company, or in some cases part owners. I am not surprised that they taut the wonders of SiN as they all stand to make a lot of cash if it gets taken out.
ReplyDeleteThe Emerging Spine Meeting, hum, lets see - it has a budget of $500,000 for a three day meeting that these guys above throw for themselves, their families, and their friends at top-notch ski resorts and pass the tab straight onto exhibitors. I wonder if Stryker, NuVasive, and Medtronic will continue their "Platinum $50,000" contribution this year...? To gain entry, the minimum exhibit fee is $15,000. Don't these guys know that America and the rest of the world are in the throws of a terrible recession. Oh by the way, guess who has a prominent position in the meeting... Surprise - it's AMEDICA!
One can only wonder how much business Stryker, Nuvasive, and Medtronic do with these guys annually?
MM 3:11am --- Nice!
ReplyDeleteAnon 4:18am --- So true. After 3 years with that love-in we are done. No return
Flexuspine?
ReplyDeleteHas there been one surgeon on this thread? It sounds like all sales.
ReplyDeleteSurgeons are overrated...5:34. They think what we tell them to.
ReplyDeleteShort answer...no.
ReplyDeleteBiologics are over-rated. It's about the carpentry, stupid.
If biologics and biomaterials are over rated how many surgeons are still chiseling a big chunk of bone from the hip or long bone of the patient to use as an interbody device? In the next 20 years there will be injectables and no fixation whatsoever
ReplyDelete11:22
ReplyDeleteIs that a fact, Nostradamus?
He's probably correct in stating that injectables will be a large part of the Tx for DDD.
ReplyDeleteTrauma, stenosis, spondy, deformity ( at least neuromuscular), etc. -- Fixation will still be needed.
I would be willing to bet at least 50% of people on this blog have no clue who Nostradamus is
ReplyDeleteLady GaGa's boyfriend?
ReplyDeleteThe most exciting (but possibly most fluff injected) technology about to emerge is the polymer-based scaffold made by Invivo Therapeutics for the repair of spinal cord tissue.
ReplyDeleteThe CEO has a questionable background, but overall their research seems pretty sturdy. I'm not even sure if they have been approved for clinical trials yet, but their research has shown no overwhelming benefit of stem cells being used to repair the dura.
what about expandable PEEK PLIF/TLIF cages...and I'm not talking about Spine Wave's Staxx, they have an uncanny knack on "spitting". SpineSource's WAVE cage is pretty solid.
ReplyDelete