CE Mark for JenaValve TAVI System Extended to Cover Aortic Insufficiency

German Transcatheter valve company JenaValve Technology, Inc., has received CE 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.

Background

JenaValve Technology says its device is now the only TAVI device worldwide approved for the treatment of high-risk or inoperable patients suffering from severe AI. The CE Mark expands on JenaValve’s initial September 2011 CE Mark approval for the treatment of stenosed and calcified aortic valve diseases and means it is now approved for the entire range of aortic valve disease regardless of calcification.

Despite being up against some serious competition in the form of Edwards Lifesciences, Medtronic, St.Jude and even Direct Flow, JenaValve is sounding pretty punchy about its competitive advantage which it attributes to its patented clip-mechanism. This permits what the company calls  “active fixation” to the diseased valve leaflets and works regardless of the degree of valve calcification. The JenaValve TAVI system is clipped and fixed on the native valve leaflets in a manner similar to a paper clip.

JenaValve says its competitor valves are not suitable for AI because they require a certain amount of calcification in order to properly position and secure their valve prosthesis. Without calcification they say there is significant risk that these other devices will migrate into the aortic arch causing risk to the patient. And indeed we know that residual paravalvular leakage remains an issue for earlier scaffold-type devices.

Physician comments

Prof. Hendrik Treede, M.D., Director of Minimally Invasive Cardiac Surgery at the University Heart Center Hamburg, 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 contraindications for surgery. First generation TAVI devices require substantial oversizing in non-calcified annuli carrying the risk of paravalvular leakage, valve migration or further annulus dilatation. The JenaValve TAVI system has proven safety and efficacy in catheter-based treatment of pure aortic regurgitation in sufficient numbers of patients. The unique 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.”

Company comments

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 AI. 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.”

Source: JenaValve Technology, Inc.