Researchers will test Sapien 3 on up to 1,000 intermediate-risk patients with severe symptomatic aortic stenosis, following the FDA's decision to grant an Investigational Device Exemption for a single-arm nonrandomized clinical trial. The latest study follows the completion of an earlier U.S. trial focused on patients with the same condition deemed inoperable or at high risk for surgery.
This next-generation device isn't available yet, but executives expect a CE mark "in the near future," according to the study announcement. Sapien 3 is pitched as a big advancement over the previous models, with improvements such as a change that helps address paravalvular leak. It's designed to be implanted using a transfemoral approach through a leg incision and by other means. The target U.S. approval date: by 2016.
Edwards, of course, has international approval for Sapien as well as a U.S. monopoly. It is working hard to keep up the momentum, with expectations to win FDA approval for its lower-profile Sapien XT in the first half of 2014.
Edwards upset investors in 2013 when it posted less-than-impressive sales increases for Sapien and didn't exactly offer a stellar future forecast. But it has worked hard to protect the sizable market it has generated and convince investors that Sapien will deliver. For example, Edwards has had some success beating back archrival Medtronic ($MDT) in a long-running patent fight. A German court issued a (now overturned) injunction on CoreValve sales, and in the U.S., the Supreme Court rejected Medtronic's efforts to overturn a patent verdict that cost it $83.6 million. CoreValve's U.S. approval is expected this year. (Expect more legal moves from Edwards when that happens.) Boston Scientific ($BSX) won a CE mark for its Lotus valve in October, and St. Jude Medical ($STJ) gained CE mark status for a larger size of its Portico transcatheter aortic heart valve just in December.
Edwards said in December that it expected Sapien to generate between $700 million and $820 million in revenue in 2014, well below analysts' estimates. Increased competition plays a large part in that, which makes Sapien 3's trial success all the more crucial in the months ahead.
- read the release
Editor's note: This story has been updated to reflect that a German court subsequently overturned an injunction on Medtronic's CoreValve sales.