It's tough to know what's "normal" for the natural history of a medical device, but it appears the path to maturity for those first-of-a-kind, high-risk circulatory system devices is more drawn out than in times gone by. Now that TCT 2013 is upon us, we might reflect on a third anniversary of sorts of the Sapien valve, a member of a class of devices that may or may not be described as a mature technology.
The fanfare over the Sapien TAVR at TCT 2010 might seem a bit conspicuous now after the passage of 37 months. Edwards Lifesciences had unveiled data from the Partner trial that year, and the consensus seemed to be that the trial was a resounding success. Still, another year would pass before FDA approved the device, a stark reminder of the device lag American patients have faced for a number of years now.
Edwards purportedly invoked parallel FDA/CMS review, but it did not appear CMS got involved until Edwards had wrapped up its first regulatory filing, leading one to wonder about the meaning of “parallel.” CMS had proposed covering the device under coverage with evidence development with a mandate for post-approval studies intended to demonstrate superiority to the comparator, but doctors were quick to lambaste the superiority idea publicly, even if Edwards was mum in public on the notion.
Everyone still remembers the patent battles that have plagued coronary artery stents, so of course Edwards and Medtronic are embroiled in their own patent showdown over TAVR. The Supreme Court recently opted not to hear the case, but a lower court will still review the argument for injunction of the firm's CoreValve. Medtronic is not out of the woods just yet, and hence Edwards could have the U.S. market to itself for several more years.
Docs annoyed over both coverage and reimbursement
Another consideration in all this is that while CMS agreed in May 2012 to cover TAVR under CED, there has been a ton of grumbling over Medicare reimbursement for the device/procedure. Among their grievances is that payment is scattered across several diagnostic-related groups, and the payment level depends in part on whether the hospital provides indirect medical education. Of course, the Centers for Medicare & Medicaid Services made it clear early on it didn't want every Dr. Tom, Dick and Harry practicing the device as evidenced by the institutional experience and staffing mandates that are conditions of coverage. So we might safely assume these nagging reimbursement issues won't ease anytime soon.
One of the really interesting features of TCT 2013 is that the discussions of adverse events are picking up, including thrombosis. Don’t get me wrong, they’re not piling on the way electrophysiologists did on the St. Jude Riata. Still, docs are clearly not keen on repeating the roller-coaster ride provided by drug-eluting stents. If memory serves, the rates of thrombosis between DES and bare-metal stents evened out after two or three years, but there was a lot of whiplash for device makers, docs and FDA. None of them is in a hurry to revisit that experience, especially FDA, one of whose members characterized the episode as the “DES trauma.”
To summarize: We have the world's best market for devices served by a single manufacturer; a patent fight between that firm and the only competitor in a position to challenge anytime soon; coverage that requires financing a registry; reimbursement that leaves most interventional cardiologists with the blues; and a cadre of researchers intent on shining a light on every little blemish. Excuse me for invoking a cheap simile, but that sounds less like a device that's ready for prime time and more like a technology that still has a zit or two to clear up.