We expect the Supreme Court to act, at least once it commits to a case. The FDA, that’s another thing. But the FDA has been on a relative tear this month with nearly back-to-back approvals of two different transcatheter aortic valve replacement (TAVR) systems.
I don’t mean to diminish the significance of the justices’ decision in support of subsidies nationwide for health insurance exchanges. This second challenge to the Patient Protection and Affordable Care Act would have created mayhem in the 34 states that relied on federal subsidies had the High Court ruled against them. More than 6 million people would have been affected.
On June 17, Edwards Lifesciences announced that the FDA had granted it approval for marketing the balloon-expandable Sapien 3 TAVR valve, its third-generation device. The approval covers patients with severe aortic stenosis who are at high surgical risk. Sapien 3 has a smaller profile than its predecessors with a skirt that is designed to reduce paravalvular leak.
Less than a week later, the FDA opened the doors for another TAVR valve, this time Medtronic’s Evolut R system. The approval allows physicians to implant the self-expanding Evolut R in extreme- and high-risk patients. The Evolut is the first valve available in the U.S. that can be recaptured and repositioned. It, too, has a smaller profile than the previous-generation CoreValve devices and the 26 mm and 29 mm sizes include a sealing skirt.
Contrast that with the pace of approvals that made TAVR available in the U.S. The first Sapien valve received the FDA’s blessing in inoperable patients in late 2011. The agency gave the nod for high-risk patients about a year later. The second-generation Sapien XT was approved for both patient groups in 2014.
CoreValve for extreme-risk patients entered the U.S market in January 2014 and for high-risk patients five months later. Earlier this year, the FDA approve CoreValve for valve-in-valve procedures, too.
The FDA’s springing to action has been a plus for patients. These newest TAVR devices have advantages over the first round of valves, and that is translating into better outcomes.
Right now Edwards and Medtronic share the U.S. market and have no incentive to lower the $30,000 or more cost of a valve. Most interventional cardiologists and surgeons predict that competition will drive prices down, and Boston Scientific, Direct Flow Medical and now-back-in-the game St. Jude Medical are poised to test the hypothesis. Other companies also have TAVR valves in development.
Let’s hope this momentum continues.
Editor, Cardiovascular Business