TSB thought that Dynesys was rounding third and heading home as a device that could have stand-alone use. Much to our chagrin and in the spirit of the sixth game of the World Series, Dynesys was thrown out at the plate!
In closing the FDA declared that the device holds promise. TSB must ask our readers, what does that mean? How vague can the FDA get?
The FDA panel just said that the IDE/PMA process is irrelevant. It doesnt matter what data means if the device doesnt make optical sense that is all that matters. Compnaies now are told to invest 15-50 million on an IDE clinical trial and that there are no rules or regulations. If not apparent my opinion is that the current PMA process is criminal to industry and that the FDA has no competency in understanding the concepts of business.
ReplyDelete"Home"....well put! There is the theory that goes if Advil didn't exist today, it would cost half a billion to test clinically, and the FDA would still not approve it for market.
ReplyDeleteI believe in a reasonable governing body protecting consumers and making sure medical technology is safe and effective. But they are beginning to border on Draconian. I fear that onces new healthcare legislation passes, it will only cement that culture of hyper-protectionism at the FDA, without any concept or understanding the business of medical device development.
With millions being added to insurance coverage, will FDA's logic be that they have to apply even more scrutiny to devices since they have the potential to be implanted in millions more Americans over the next decades? And with a 5-1 vote, it shows that a more than a majority at FDA feel this way.
A concerning descision for our industry....
SpineSearch, agreed, except one point. That 5-1 vote isn't of FDA employees, but consultants to FDA, such as surgeons and biostaticians. But that's part of the problem. The panelists are brought in at the very end, and just start second guessing the trial design. The panelists are given so much leeway, and by and large FDA goes along with their vote. It's a silly part of a silly system, which has the impact, right or wrong, of killing all but the most mind-bogglingly innovative devices.
ReplyDeleteSpine Search, I don't disagree that even aspirin today would not stand a snow ball's chance in hell to get approved. However, what is it that Dynesys is trying to do? Here are two sentences from the patient information web page, just one paragraph apart:
ReplyDelete"It offers a unique approach to stabilization and mobilization of the spine and pain relief"
"The Dynesys System can be used in skeletally mature patients to provide immobilization and stabilization of spinal segments."
Confused? You bet as a lay person I would be!
Back in 1990 it was already demonstrated that even a rigid plate system like VSP (Variable Screw Placement, Art Steffee)still let 80% of the compressive loads pass through the anterior column. So, what is Dynesys trying to be and do, other than being something visibly different from the rest?
Cerevertebral: No need to say any more! Great Comment!
ReplyDeleteI just want to know why the Prophet CEO Damien McDonald allowed corrupted data to be submitted to the FDA. Mr. McDonald was supposed to be the leader of a new Zimmer spine that was no longer going to participate in questionable practices. I guess this one got by Damien’s Firewall… Kudos to the FDA panel for taking a stand, Damien as the phrase goes “garbage in – garbage out”. Mr. McDonald’s tenure at Zimmer Spine is going to make for a great HBR case study on the “things not to do” as a CEO of a Spine company.
ReplyDeleteOrangeman: It's evident that these publicly traded companies love to elevate people that use a lot of words and never say anything! There's an art to bs'ing the public and the FDA!
ReplyDelete(From a different David) The implications of this decision are fascinating. Of course, FDA can still buck the panel- e.g. X-Stop. They have the choice of either disregarding the study data that certainly suggests equivalence (or better) or disregarding their own panel. They are in a tough position but its bound to happen when you have such an 'independent' panel brought in at the last minute.
ReplyDeleteHow will this impact investment dollars going into the myriad of dynamic stabilization companies? The industry clearly needs better solutions and it would be a shame if investors decide to abandon the industry wholesale, rather than looking for truly innovative products.
One of users for Dynesys, I knew some shortcomings of Dynesys. But I have gotten excellent clinical outcome with non-fusion application. I believe that fusion is not needed in many degenerative spinal diseases and my results say. It just political decision for fusion companies.
ReplyDelete