JenaValve Technology has announced it has received CE mark approval from European regulators for its transapical TAVI system for the treatment of aortic insufficiency.
The JenaValve is now, according to the company, the only TAVI device worldwide approved for the treatment of high-risk or inoperable patients suffering from severe aortic insufficiency. The CE mark expansion, which is an addition to JenaValve’s initial September 2011 CE mark approval for the treatment of stenosed and calcified aortic valve diseases, enables JenaValve to market its product for aortic insufficiency to physicians and their patients throughout all countries who recognise the CE mark.
JenaValve CEO Helmut J Straubinger said: “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 aortic insufficiency. Today, open-heart valve replacement surgery is the standard procedure for aortic insufficiency 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’s competitive advantage for aortic insufficiency is attributable to its patented clip-mechanism that allows for “active fixation” on the diseased valve leaflets and requires no calcification of the native valve to be implanted and effective. The JenaValve TAVI system is clipped and fixed on the native valve leaflets in a manner similar to a paper clip.
Hendrik Treede, director of Minimally Invasive Cardiac Surgery at the University Heart Center Hamburg, Germany, said: “Severe aortic regurgitation is an indication for surgical aortic valve repair or replacement in the majority of patients. Nevertheless there is a need for interventional catheter based aortic valve implantation in patients at high surgical risk or with 2 contraindications for surgery.
The JenaValve TAVI system, the company states, has proven safety and efficacy in catheter-based treatment of pure aortic regurgitation in sufficient numbers of patients. The clip mechanism fixes the native leaflets to the stent thereby achieving anatomically correct implantation and full coverage of the native annulus without the need for extensive oversizing and without paravalvular leak. Transapical JenaValve implantation has become the treatment of choice for patients with pure or predominant aortic regurgitation at high risk for surgery at the University Heart Center Hamburg.