Edwards Lifesciences' ($EW) Sapien transcatheter heart valve has already performed well for the company since it gained an initial FDA approval in November to treat patients with limited classes of stenosis who can't have surgery. But executives want to expand its use to another class of patients with severe, symptomatic aortic stenosis that could handle surgery. At stake is a $2.5 billion transcathether valve market in the U.S. alone, according to a Canaccord Adams estimate cited by Bloomberg.
All of that starts coming to a head on June 13, when the company gets to make its case for expanded approval before the FDA's Circulatory System Devices Panel, which will recommend whether or not regulators should use the valve as an alternative to surgery. Regulators don't have to follow the panel's decision, but they almost always do.
In advance of the hearing, FDA scientists have pointed to at least one area of concern. According to Bloomberg, they believe the way the company chose patients and categorized them for a clinical trial included some bias. As a result, they argue, deciding whether the device can serve as a viable alternative to surgery may not be easy.
Another point of concern, as Bloomberg points out: FDA staff noted that patients treated with Sapien faced twice the stroke risk in the initial month after the implant procedure, compared to patients who had open-heart surgery instead.
The FDA wants the company to commit to a long-term follow up, post-approval study that tracks patients for at least 5 years to address its concerns. Edwards appears to be on the same page, having proposed a post-approval study that would follow patients from its pivotal trial, as well as a new patient registry, according to the story.