JenaValve, fresh off of a $63 million funding round, said it won CE Mark approval in the European Union for its transapical replacement heart valve to treat aortic insufficiency, also known as aortic regurgitation.
The expanded approval makes JenaValve’s transcatheter aortic replacement valve implant the world’s only such device approved to treat high-risk or inoperable aortic insufficiency, according to a press release.
Wilmington, Del.- and Germany-based JenaValve won a CE Mark for the device in September 2011.
"The granting of a CE Mark expansion to cover the clinical indication of aortic insufficiency is testament to the unique design of our valve and will provide a new option for thousands of patients; more than 23% of all patients with native aortic valve diseases suffer from AI," CEO Helmut Straubinger said in prepared remarks. "Today, open-heart valve replacement surgery is the standard procedure for AI patients, high-risk patients or inoperable patients are treated conservatively with drugs. According to published clinical data, the yearly mortality rate of these conservatively treated patients is approximately 25%. For these patients, the JenaValve now provides a beneficial alternative treatment opportunity. This new approval means our transapical TAVI system, compared to all other competitors, can now treat the broadest range of patients."
JenaValve pulled in a $63 million Series C round in July. It’s 1 of several smaller players in the TAVI space hoping to challenge market leader Edwards Lifesciences (NYSE:EW), arch-rival Medtronic (NYSE:MDT) and other big device makers like St. Jude Medical (NYSE:STJ) and Boston Scientific (NYSE:BSX).
Although Medtronic was first to market with its CoreValve TAVI in 2007, Edwards wasn’t far behind, putting its Sapien TAVI in the EuroZone a few months later and beating CoreValve to the U.S. market late last year. St. Jude is next in line with its Portico TAVI device, which won CE Mark approval in November 2012 and has a U.S. investigational device exemption trial slated to start in 2014. Boston Scientific’s Lotus valve could win CE Mark approval by the end of this year, backed by data suggesting that it delivers lower rates of paravalvular leakage at 30 days compared with rival devices.
JenaValve is chasing Direct Flow Medical for the U.S. market. Earlier this month Direct Flow launched an investigational device exemption trial in the U.S. after winning FDA approval in June and CE Mark approval for its eponymous device in January. Then there’s Symetis, which has had a transapical TAVI on the market in Europe since 2011.
In February JenaValve lured John Migliazza, a 12-year veteran of Edwards Lifesciences (NYSE:EW) who most recently was Edwards’ senior director of engineering, to be its new COO.
