There’s a lot to be said for gatherings like TCT. It brings device makers, doctors, and FDA together in a way that seems formulaic, but there’s nothing like face time to help people with sharply opposing views to hash out their differences without wanting to sling the phone through a window. Still, there are stories that remain untold, such as the following.
PMA and 510(k) may rhyme, but …
This year’s edition of TCT provided plenty of content about how well FDA and industry are getting along these days, and it does appear the agency wants to make the PMA path a bit less constipated.
TCT is all about those high-risk PMA devices, though, so you don’t hear about the 510(k) program. That’s understandable, but after the hubbub dies down you may still hear some grumbling by makers of moderate-risk devices – some of whom are also in the high-risk end of the business – that FDA is still adding drag to class II device filings.
Among the gripes is that the agency is using the newly-expanded de novo program to force some would-be 510(k)s into a regulatory channel industry believes is needlessly burdensome. Given that 510(k)s account for more than 90% of all device applications, this less conspicuous wrestling match might have more to say about aggregate future investment in the U.S. than anything going on in the world of PMAs.
CoreValve v. Sapien: Patent clash of titans or thundering dud?
The face-off between Edwards Lifesciences and Medtronic over market share for TAVR continues, and unlike TCT 2010, CoreValve is the darling of this year’s gathering. Still, there’s the matter of patent lawsuits hanging over Medtronic’s head, both in Europe and in the U.S.
Medtronic seems unruffled by the predicament. The company indicated in an investor’s conference call that matters in the European Patent Office are not irretrievably out of control, and no one on the call mentioned the U.S. patent suit at all. The U.S. Supreme Court recently declined to hear the suit after CAFC found some parts of the CoreValve patent to be infringing, but the matter of injunction appears to be headed back to a lower court. You would never know there’s a problem in the U.S. to hear Medtronic (not) talk about the situation.
It’s easy for a layperson to infer from the language of the ruling at CAFC that the case for injunction is weak – the decision describes the conditions under which injunction is more remedy than indicated – but there’s that nagging question of why Medtronic tried to get cert at the Supreme Court if this is nothing but noise.
Medtronic is so blasé about the whole thing that one has to conclude that either they’re bluffing (a dangerous gambit in a world of investor activism) or they don’t believe Edwards is going to gain any traction on injunction. That doesn’t necessarily mean Edwards is out of ammo where the U.S. patent fight is concerned, but I’m still struggling to reconcile Medtronic’s deeds with its zipped lips.
So my default position is that only time will tell which side will find that the silence over the U.S. patent fight is truly golden.