JenaValve TAVI System Receives Extended CE Mark Approval

September 19, 2013 – JenaValve Technology Inc. has received CE (Conformite Europeenne) mark approval from European regulators for its transapical TAVI system for the treatment of aortic insufficiency (AI), also known as aortic regurgitation, in which the native aortic valve does not close properly and allows blood to leak back into the left ventricle of the heart.

The JenaValve is now 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 AI to physicians and their patients throughout all countries recognizing the CE mark. The JenaValve is now approved for the entire range of aortic valve disease — from severely calcified to not calcified at all.

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 percent 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 percent. For these patients, the JenaValve now provides a beneficial alternative treatment opportunity."

JenaValve's competitive advantage for AI 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. Other competing TAVI products 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, there is significant risk that these other devices will migrate into the aortic arch causing risk to the patient. Clinical studies performed with competitor devices in patients with pure AI revealed unsatisfying results with a high number of residual paravalvular leaks requiring second interventions. [1]

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."

For more information: www.jenavalve.com

1. Roy DA, Schaefer U, Guetta V, Hildick-Smith D, Möllmann H, Dumonteil N, Modine T, Bosmans J, Petronio AS, Moat N, Linke A, Moris C, Champagnac D, Parma R, Ochala A, Medvedofsky D, Patterson T, Woitek F, Jahangiri M, Laborde JC, Brecker SJ. Transcatheter Aortic Valve Implantation for Pure Severe Native Aortic Valve Regurgitation. J Am Coll Cardiol. 2013 Feb 14