German-based JenaValve Technology has obtained CE Mark approval for its transapical transcatheter aortic valve implantation (TAVI) system, designed to treat aortic insufficiency (AI).
AI, also known as aortic regurgitation, is a condition where the native aortic valve will not close properly and leads to blood leakage into the left ventricle of the heart.
The TAVI device is reportedly the only device across the globe to receive approval for treating high-risk or inoperable patients with severe AI.
JenaValve Technology had obtained CE Mark approval in September 2011 for the treatment of stenosed and calcified aortic valve diseases and with the new CE Mark approval for the TAVI system, the company has now gained approvals for the entire range of aortic valve disease - from severely calcified to not calcified at all.
JenaValve Technology's competitive advantage for AI is attributable to its clip-mechanism, which enables active fixation on the diseased valve leaflets and does not require calcification of the native valve to be implanted and effective.
JenaValve Technology CEO Helmut J. Straubinger noted this new approval means the company's transapical TAVI system, compared to all other competitors, can now treat the broadest range of patients.
University Heart Center Hamburg director Minimally Invasive Cardiac Surgery Dr Hendrik Treede noted the JenaValve TAVI system has proven safety and efficacy in catheter-based treatment of pure aortic regurgitation in sufficient numbers of patients.
