neuro-modulation products, an artificial disc company, a fibrin sealant, a nitinol instrument to be used in conjunction with PMMA that provides a scaffold for VCFx, an annular repair device, a hemostatic agent, a synthetic cartilage, tissue engineering, and a bio-ceramic.
The appealing aspect of these placements is that investors are selectively choosing to invest in peripheral spinal companies. Hopefully this is a good sign for our future and a bad sign for companies that are intent on saturating the industry with additional "me too" products into a zero-sum market. So let's take our hats off to those that were able to be part of a growing trend, and hope that those that entered this industry with the irrational exuberance get the hint, the train left the station and you no longer are on the same track. Please ingratiate our followers and twitters with your thoughts, TSB wants to know what our readers think about some of these technologies?
I have seen half of these new technologies as they come through our center as part of their upcoming FDA IDE's. Definitely a refreshing new wave of goodies as opposed to just another disc replacement. However, some of these ideas have seemed a little desperate--as in all that venture capital sitting on the sidelines is looking desperately for a home--and I'm not sure how much application/practicality these products will have beyond the IDE.
ReplyDeleteSadly, the FDA only seems to know how to issue a 510k to a me-too device, lacking the wherewithal to understand the implications of something genuinely new. Ministers of Grace, defend us all...
ReplyDeleteI tried to search the blog about "annular closure devices" but did not find anything. I belong to the research community and I think one of this class of devices will solve at least a part of the problem for a good chunk of well-chosen patients.
ReplyDelete