JenaValve Technology, Inc., a privately-held, venture-backed developer, manufacturer and marketer of transcatheter aortic valve implantation (TAVI) systems for the treatment of aortic valve disease, announced today that it has been named to the FierceMedicalDevices “Fierce 15” list, designating it as one of the most promising private companies in the medical device industry in 2013. JenaValve was chosen as one of the Fierce 15 based, in part, on the innovation and promise of the JenaValve TAVI System.

“JenaValve and the other Fierce 15 companies we chose represent some of the best and brightest in the device and diagnostic industries today,” FierceMedicalDevices Editor Damian Garde said. “They’ll be producing big things in the months ahead.” 

The global market for TAVI systems is expected to grow to more than $3 billion in 2016. 

Last month, the JenaValve TAVI System was granted CE (Conformité Européenne) Mark approval from European regulators for its transapical TAVI system for the treatment of aortic insufficiency (AI), a condition also known as aortic regurgitation in which the native aortic valve does not close properly, allowing blood to leak back into the left ventricle of the heart. The JenaValve is now approved for the entire range of aortic valve disease - from severely calcified to not calcified at all – and is the only TAVI device worldwide approved for the treatment of high-risk or inoperable patients suffering from severe aortic insufficiency. 

“We are encouraged that medical device editors in the US are recognizing the value of the JenaValve TAVI System, and even more important, the large and growing patient population that can now benefit from our proprietary devices,” said JenaValve CEO Helmut J. Straubinger. “Our unique technology and the design of our valve are our competitive advantages. We are looking forward to expanding our commercial footprint in new geographies around the world.”