Edwards ($EW) won the FDA's conditional go-ahead to begin a clinical trial involving as many as 500 patients for a new iteration of its Sapien transcatheter aortic heart valve implant. The U.S. approval process for cardiac implant trials typically has dragged on much longer in the past, and the company, in an unusual move, thanked regulators for moving so quickly.
"We appreciate the FDA's efforts to allow initiation of this trial in a timely way," Larry Wood, Edwards' corporate vice president for transcatheter heart valves, said in a statement.
Only Edwards' first-generation Sapien transcatheter aortic heart valve (TAVI) has FDA approval. And many more Sapien models have been available for years overseas. As Reuters has previously noted, U.S. cardiologists have become frustrated because they have far fewer transcatheter aortic valve replacement options than are available in Europe. Companies, in turn, have relied on generating revenue by seeking European approval first, but the U.S. is also a robust market, so those delays hurt. To address concerns, the FDA debuted its new modular approval program earlier this year, in which data can be reported incrementally to allow clinical trials to move more quickly.
For Edwards, which pursued a regular IDE process, the FDA granted a conditional investigational device exemption to test Sapien 3 in patients with severe symptomatic aortic stenosis who are otherwise ineligible for surgery. Up to 500 patients will take part. And researchers will pursue three different kinds of implantation: through an incision in the leg, the transapical option between the ribs and transaortically by way of a small incision in the chest and aorta. Expectations are that Edwards will use a one-year composite endpoint versus previous Sapien valves.
Edwards bills Sapien 3 as an improvement, in part because of its "lower profile" and advances such as a fabric cuff designed to reduce paravalvular leaks.
The other thing that matters here is Sapien itself. In the 2013 second quarter, Sapien generated almost half of Edwards' $182 million in revenue. And the company has remained a fierce protector of its Sapien patents, pursuing aggressive legal action against rival Medtronic ($MDT), for example. And so a more efficient regulatory process with the FDA may be a crucial ingredient to keep the Sapien train running smoothly.
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