One of the first products to hit the market was TruFuse which was designed to address facet degeneration. TruFuse is a tapered dowel and when introduced caused a serious stir from the surgical community. VGI with VertiLoc was another design that claims the device resists rotation and can be locked in place after implantation. It seems that VerteLoc has done admirably in a volatile market. NuTECH came out with NuFix a allograft dowel manufactured out of the femur or tibia. Litigation! Litigation! Litigation! As of last week, another player debuted in this space, its name is Facet Fusion Technologies out of San Antonio, Texas. FFT's claim is that with a rectangular/wedged shaped design with simplistic instruments, this device can withstand shear forces much better than the aforementioned products. So in the spirit of democracy, and with due respect to some of the other facet technologies (US Spine, Spinal Elements and Facet Solutions) what do our readers think of these products, and if needed, would you have these products implanted in your own spine? TSB wants to know?
Tuesday, November 17, 2009
Is it NU and is it TRU does it LOC and does it FUSE?
As more and more entrants enter the race to sell their products for facet fusion, TSB would like to enlist our readers knowledge, and opinions, about some of these devices. Having an inquisitive personality has always been a short-coming of mine. Recently, we have been contacted by multiple companies regarding their facet fusion devices. In order to provide our readers, which does include patients, some positive feedback, TSB would like to know will some of these devices make a difference in alleviating associated back pain?
Subscribe to:
Post Comments (Atom)
Use one of these in my body? Nyet. It seems that everyone and their dog has a product in this area. Walking around the NASS floor last week, I saw the companies mentioned along with Bacterin (looking exactly like NuFix), Osteotech, Osprey (who are they anyways??), and I'm sure I missed 10 others. All I can imagine is going out for a quick 9 holes, bending over to tie the old shoes and POP.
ReplyDeleteDuke: Many of our readers communicate to me via e-mail and I must admit you are one helluva entertaining blogger! Thanks for your feedback, the Poll Continues!
ReplyDeleteI am intrigued by these products and have performed a lot of research. I visited just about all of them while at NASS. To limit motion of the facet joints, a product has to address the biomechanical forces placed upon them in all movements. There is only one system, in my opinion, that even has a chance, and that is Verteloc. Their engineer, who is a PhD in spine biomechanics, explained the system to me and it makes sense as all of the forces are placed at 90 degrees perpendicular to the implant's surface because of its design. This does not guarantee that it will not migrate, but it does mean that it has the least risk of migration. When speaking to representatives from the other companies, it was all about sales and not engineering, so I wasn't as impressed.
ReplyDeleteMy opinion is the Verteloc implant design could also be effectively used in other areas, such as small joints. I personally think this company is on to something that could be big with their multi-geometry implants. They also had another system for lateral interbody fusion which was based off of a similar design. I think they said it would be available sometime next year.
My question is, does anyone know if they have VC money or any other type of significant funding behind their efforts? If they have the resources I think everyone will see some real innovation for a change. I like companies like this that actually base their products off of real engineering and not just a calculated guess. Several companies that were based off of calculated guesses and me too products have already failed in '09 and I think there's more to follow.
Just my two cents........
Any impressions on the trans-facet compression screw from interventional spine? In the realm of facet fixation this product, in my opinion, makes the most biomechanical sense.
ReplyDeleteI think that facet motion preservation technologies are very different from facet fusion technology--and both have their place. In the area of facet motion preservation, there are many differences as well. Facet Solutions' products (they also own the IP from Archus) are designed to address stenosis. Facet Solutions' technology removes the facet joints and rebuilds them out of metal. Spinal Element's products are designed to address facet joint pain and are designed to be used earlier in the continuum of care. Interesting area...
ReplyDeleteThe trans-facet compression screw, from my understanding, could be used with an interbody fusion device where a facet fusion allograft product could not. However, if the disease indication is caught early, a facet fusion allograft device could be useful (if it fused) in the prevention or delay of additional surgical procedures. Each product has its distinct advantages.
ReplyDeleteFacet screws work. BUT, as with everything, patient selection is key. I have seen these used on patients with a multitude of pathologies; this is a bad candidate. Bone dowels in the facets DO NOT work. This is a pain management procedure attempting main stream medicine. This procedures creates additional surgical candidates, to this extent it may be "good" for the market in promoting it. Duke was accurate, they pop out. In some instances these are seeing 100% revision rate. Pain guys will bill this as a fusion for patients where a cortisone injection would have done better.
ReplyDeleteFacet arthroplasty, is not a good idea. VC's are moving away from this.
I have sold 2 of the above Allograft fixation products and my surgeons have had good to great results! Using them as part of a multilevel lumbar lami decompression, adjunct to an ALIF, and on the contralateral side of an MIS TLIF. I have seen several revisions and backouts with Trufuse but knock on wood none with the the better engineered dowels. I have no pain mgmt guys using the products so I can't speak to that side of the story. Some guys think its quackery but everyone that has tried the procedure is still using the facet fusion products on the right patient with good results. When doing the procedures MIS it is especially important to make sure you are in the facet joint, which isn't always easy or the products are sure to come out. I look forward to some good literature coming out showing the benefits of facet fixation~
ReplyDeleteMedical Device Ventures, you don't know what the heck you're talking about! It is evident that you have no clear understanding of biomechanical forces of the spinal column OR how to address them.
ReplyDeleteI honestly think we will see facet fusion procedures grow in popularity with surgeons over the next 24 months. I also think that the first company to release some real clinical data on these products will be the winner. I have a friend that's selling Verteloc and his surgeons love it AND he states that the post-op CTs look good. He previously sold the round dowel-type products.
I'd place my bet on the company that DOESN'T produce a round dowel type of implant. Round rolls, just like a wheel.
Just wait and see, as I am confident that I will have the opportunity to say.......I TOLD YOU SO!
I totally agree with the last comment. The only allograft implants that "pop out" are the ones that are incorrectly designed! The only allograft implants that "don't work are the ones that are incorrectly designed, and we all know who fits both of these profiles. To say that this is a pain mgt procedure shows a total lack of understanding about what allograft facet implants are supposed to address. They are simply an adjunct to fusion whatever the primary fusion methodology is. Facet screws are for fixation MDV!! your confusing two different procedures.
ReplyDeleteThe comment above is absolutely correct, place your bet on the implant that is NOT round.
The Verteloc or the Osteo Facet Wedge will rise to the top over the next several months.
For one who really understands biomechanical forces, the Osteo Facet Wedge poses an inferior design rationale. Here's why. The implant, by its design alone, would be weak in addressing forces in flexion / extension, lateral bending and torsion. The edges being at 90 degrees will have greater forces placed upon them, which could potentially lead to failure.
ReplyDeleteVarious sources say that the company is actually owned by a surgeon from Texas who used to use both the round dowel products. Wow, let's take an implant designed like a 'wood splitting' wedge and drive it into the facet joint, as that should clearly stop the motion. I don't think so.
From an engineering standpoint, there is only one company in this market space that has designed an implant that could possibly work, and that's VGI.
I'll take that bait just for fun as I do enjoy the debate. It's obvious you're with VGI and that's fine. I've checked out your product as well as the others and most recently the Osteo Facet Wedge at NASS as I believe it is the newest entry into this "family" Your Biomechanical explanation is so full of holes as to be swiss cheese. For short the OFW would be no more susceptible to flexion/extension issues than the other designs. I would argue that it is probably far LESS susceptible as it is the only implant I am aware of that has angled anti backout teeth. The fact that it is rectangular also gives it more surface contact than a round design. That's just a common sense conclusion that a layman would come to.
ReplyDeleteYou bring up the 90* issue which again your totally missing the advantage there in my opinion. I think this is a great idea on their part, a rectangle in the joint provides 4 points of 90* angle to the joint. A right angle is necessary to resist shear whereas a round design simply has no resistive force.
A round design cannot resist shear forces compared to a right angle.
You need to bone up on your understanding of engineering principles if you think otherwise.
FYI I checked this out and the company is owned by a distributor/manufacturer in San Antonio, TX. I am curious what that would have to do with the performance of the implant as that was what the debate was about.
You sound very threatened???
One nugget that does tend to sway me toward the OFW is the fact that this is not somebody that spun out of TruFuse with a stolen idea.
First of all, you sir are the one that doesn't understand biomechanics. Edges of any implant, that are at 90 degrees, are weak points and cause greater stress issues, thus are acceptable to a higher level of breakage. Second, an implant that is not tapered would not need to have any type of forward or backward biting teeth to prevent it from migrating because the forces are placed equally across the entire body of it. Third, the OFW is a tapered device. Fourth, the surgeon rumored to be behind the device (and that is also rumored to really own the company), has previously used both TruFuse and Nufix. Fifth, VGI's device is not round, rather it is rectangular with rounded edges, so YOU need to become a little more educated on what are the shapes and characteristics of each implant prior to any commentary. Sixth, no I am not with VGI, but their design makes the most biomechanical sense. (At least VGI did have an engineer, who was a PhD, at their booth when I visited them at NASS. All the others just had sales persons.) And last, but not least, a wedge (by definition alone) has the ability to 'back out'........because it is simply a wedge (teeth or not). If it loosens up even .5mm, the purchase characteristics are greatly affected.
ReplyDeleteTo All: This blog is a joke. Those reading need to understand that MinSurg/TruFuse was the originator of this concept and both the presidents/owners of Nutech/NuFix and VGInnovations/Vertilok were employed by MinSurg. After employment at MinSURG they lifted the concept as did Bacterin from NuFix, the new player in Texas from Trufuse and NuFix.
ReplyDeleteIt is obvious that the "anonymus" from the start is Tov an engineer from VGI and many comments are from Dan Grayson the preseident of VGI. They are playing catch up with the two industry leaders Nufix and TruFuse. Together Nufix and truFuse have over 18,000 dowels that have been used by doctors nation wide and VGI has maybe a couple of hundred under their belt. So they must be the industry experts. 90 degree angles - show the non biased proof or be quiet.
The key is here that the industry has been greatly inhanced by them all. Many patients have been helped beyond belief by this procedure that had no other alternative with out metal implants. All of the players in the arena show it's importance and criticalness to facet pain and disease. I applaud all of the companies in continuing to develop this concept to the next level.
I think it is really sneaky for Tov the VGI engineer to come on as anonymus and act like a bystander at NASS. That's original?
Let's discuss the next generation and the way we can best help patients with facet disease.
I agree with this latest post. Wow it would appear to this interested bystander that the OFW has Tov on the run!
ReplyDeleteIt's easy for those that hide behind 'anonymous' posts to say things where they have no proof. So, let me now address their comments.
ReplyDeleteDr. Moni Stein actually developed the original concept of facet fusion using an allograft dowel in 1992. He won a Young Investigator Award in 1993 for his research. Here's a link offering proof of what I say: http://www.jvir.org/article/S1051-0443(93)71821-7/abstract
Now, who lifted what and when? You should get your information straight before you speak!
VGI launched a new and novel concept, using a dual geometric design implant, in 2008. The implant, known as VerteLoc, is totally different than any of the competitors and utilizes even a different method of preparation of the facet joint for implantation. To date, we have implanted over 2,000 implants, not a 'couple of hundred' as the 'anonymous poster claims. Yes, we have the data to back that up.
Neither Tov Vestgaarden or I have posted anonymous comments or have acted like 'a bystander at NASS', as the anonymous poster also falsely claims.
Instead, VGI is an open book. Anyone, and I mean anyone, that wants to speak with either of us regarding the biomechanics and design of our implant is free to do so. Here's our number, 336-760-2012.
The fact is, Mr. Anonymous Poster, we're taking market share from the competitors on a daily basis. And I am confident, with the information we are about to release in Q1 2010, that VGI will soon be the market leader in this segment.
I do applaud the fact that the anonymous poster has recognized that many patients could benefit from this type of procedure. However, in my opinion, companies in this market segment will be judged by the number of successful outcomes and NOT the number of implants used. For example, one could implant 20,000 screws, but if only a few worked then the product would be a failure. Thus , the company behind the screws could also fail.
So, let me put an end to this by saying, we will put our VerteLoc implant up aaginst ANY of the competitors in biomechanical testing. Run? You've got to be kidding, as the only running we're doing is 'running up surgeon acceptance and sales' to higher levels each day. Man-up, 'Mr. Anonymous Poster', as we're not scared, so bring it on!
And, 'Mr. Anonymous Poster', if you have any B&^LS, then post your name on your next comments or either give us a call. My bet is you won't do either!
Been away for the holidays, hope everyone had a great Thanksgiving. Dan, your a knucklehead. There is obviously more than 1 anonymous poster your dealing with here.
ReplyDeleteLooks like somebody got their feelings hurt last week and had to go get Daddy to come out and take up for them!
Hmmmm...I think I'll stay anonymous ......
I would like to address the last comment made on November 29, by the anonymous poster. I have to agree with Grayson. You should post your name with your comments if you are going to call people names. It appears that you're the real knucklehead.
ReplyDeleteVerteLoc™ Surpasses 750 Procedures....VerteLX™ Prototypes To Be Unveiled at Upcoming CNS Meeting in New Orleans
ReplyDeleteThe VerteLoc™ Minimally Invasive Spine Stabilization system surpasses 750 surgical procedures across the United States. VGI will unveil its new VerteLX™ prototypes at the upcoming Congress of Neurological Surgeons meeting in New Orleans, October 26 - 28.
Our VerteLoc™, system continues to grow in popularity with forward-thinking surgeons
It is making a significant difference in the way back pain is being addressed, serving to add a new option for patients and surgeons in the continuum of spine care.
The growth of VGI in just 15 months is nothing short of phenomenal
exclaimed Tov Vestgaarden, PhD, Executive VP and CTO of VGI.
Winston-Salem, NC (PRWEB), October 20, 2009 -- VG Innovations, Inc (VGI),
This was sent out on Oct 20th. So who do we trust when it comes to volume, Dan Grayson or the VG release?
Hey 'anonymous', it's like I said before, you have no b&lls. If you did, you would post your name with your comments. To address your latest BS email, there are two facet joints at each level of the lumbar spine. So, it takes two implants per level. The average number of spinal levels affected during each procedure is 1.2. (Some patients receive 1 level and others 2 levels.) Now, let me do the math for you.....(750 patients x 2 implants per level) x (1.2 levels per procedure) = 1,800 implants at the time of the press release on October 20th.
ReplyDeleteSounds like you have a personal vendetta with me? As I said before, feel free to call me anytime. You have my personal invitation to meet with me any time. But we all know, you're just going to keep hiding like a child. Step to the plate or step out of the discussion.
This comment has been removed by a blog administrator.
ReplyDeleteThis comment has been removed by a blog administrator.
ReplyDeleteWow, you guys are professionals?
ReplyDeleteVery professional indeed. This subject brings a lot of passion from different viewpoints. I was a big doubter of this technology when it first came out for a couple of reasons. 1) I was a spine rep for one of the big box companies and we didn't have one, so naturally it had to bogus or I would have had one in my bag (I have since lost that arrogance since I no longer am being brainwashed by product managers) and 2)all of the adopting surgeons in my town were, in fact, coin operated docs doing this solely for the reimbursement aspect.
ReplyDeleteI have since started my own distributorship and I represent a small company with a tapered dowel but with novel instruments that prevent the dowel from backing out (none reported so far, maybe 1000 levels to date). I do not believe that every round implant is going to roll. If the joint is distracted and there is tension when the hole is drilled and the graft is placed, the graft will not roll. At the VGI booth, they demonstrate the concept of "roll" with a dowel in a sawbones which is a very poor representation of an in-vivo facet joint. I think the VGI graft will work well, maybe even better, but a round dowel or any other shape will prevent motion if the graft and the graft bed fit hand in glove and they are placed under compression. Nobody claims that threaded ALIF cages roll, thats because there is a pair of them and they are implanted with the vertebral bodies in significant distraction.
As it turns out, there is a place for facet fusion, mentioned by earlier posters and all of the big box companies are now coming out with their own versions. Not because it works, necessarily, but because there is a demand for it. The application I have seen the most is multi level laminectomy in older patients.
Being a trufuse patient I will say I would never go through that again, the whole smoke show made sense when it was presented to us and how a full fusion was so talked down upon. After the surgery I did feel some only in the brace once the brace came off my symptoms got worse, I kept telling p/t and doc about problems finally they did a c/t scan only to find the dowels both of them came out and doc released me to permanent disable I am 28 yrs old, I just had a full fusion from an orthopedic surgeon on l4/l5 w/hardware 1 month after full fusion I am walking 1mile aday at 3mph with no brace and my back pain is getting better and I have no more leg pain.
ReplyDeleteIn late 2007, I under went bilateral posterior L5-S1 facet fusion using TruFUSE grafts. I endured intense pain and obvious instability for months following the procedure. The c/t scan showed that both of the dowels had moved out of place. I had to have a second fusion procedure and am still disabled. I was an ideal candidate for the procedure(slim, nonsmoker, no PECs, early 50's)and a compliant patient. I hope others have better outcomes than I did.
ReplyDeleteGood or bad outcomes with TruFUSE?
ReplyDeleteTerrible outcomes with trufuse as I posted before I had a trufuse last april and 4 1/2 months after surgery doc did not want to admit the surgery failed/ both dowels came out and he put me on permanent disablilty. Well being only 28 yrs old I didnt like that so I found a orthopedic surgeon and he did a full fusion through the stomach and 1 month after the fusion I was up walking 1 mile a day. The day after surger I did notice improve ment in leg pain I am 3 months out of that surgery and started p/t last month I would seriously stay away from trufuse. Also I did have that stupid brace on for 2 months So either the doc screwed up or it was flawed from the start.
ReplyDeleteSCARY. I HAD SURGERY ON 3/30/10. I HAD NO IDEA THAT THE SURGEON WAS GOING TO USE TRUFUSE. THE ONLY WAY I FOUND OUT WAS WHEN I CLEANED OUT MY SUITCASE I TOOK TO THE HOSPITAL & FOUND THE PAMPHLET. IT WAS TAGGED FOR MY SURGERY DAY, MY NAME MY ACCT# & THE BILLING CODE. THE DAY AFTER SURGERY I DID PT WITH A WALKER. HALF WAY THRU I EXPERIENCED SUCH SEVERE PAIN THAT I HAD TO USE A WHEELCHAIR TO GO BACK TO MY ROOM. THE DR ASKED ME WHAT I DID--- SEE HOW LONG THIS HAS BEEN & NOW I AM IN SEVERE PAIN ON MY ENTIRE RIGHT SIDE, CAN'T BEND, DRIVE, DO LAUNDRY, CLEANING & NEEDED TO PURCHASE A POWER CHAIR BECAUSE I CAN'T EVEN WALK AROUND. PLUS, I HAVE STARTED SEVERE ITCHING ALL OVER. I HAVE PSORIASIS ON MY ARMS & KNOW WHAT IT LOOKS LIKE. THIS IS NOT THE SAME. IT DOES NOT LEAVE A RASH, IT JUST DRIVES YOU INSANE WITH ITCHING THAT I GET VERY LITTLE SLEEP. I AM LOOKING FOR THE PHONE # TO CALL THE COMPANY. I WANT TO KNOW IF THE MATERIAL IT IS MADE OF CAN CAUSE SOME PEOPLE AN ALLERGIC REACTION. NOW I AM A LOT WORSE THAN BEFORE SURGERY. I DID HAVE PAIN CONTROLLED BY MEDICATION BUT I COULD DO ALL OF THE THINGS I CANNOT DO NOW. I BELIEVE THAT THIS OPTION SHOULD HAVE BEEN DISCUSSED WITH ME BEFORE SURGERY
ReplyDeleteDIANN
I had one placed in me in April, 2010... I am having severe neuro issues. I too swelled up two weeks after the implant. I had to go to a neurologist, vascular surgeon and now I beleive Im going to have to get this damn thing out of spine. My surgeon wouldn't tell me what he did at the time of surgery. I had to threaten to sue him to find out it was an Osteo facet wedge by Facet fusion technologies. There is nothing on the FDA site regarding this product. Why the secret?
ReplyDeleteIs it me or is dan grayson no longer the president and ceo of VG Innovations?
ReplyDelete