JenaValve CEO Helmut J. Straubinger will present for JenaValve on Tuesday, November 30, 10:30 a.m. ET, in room Kennedy 1 - 4th floor, at The New York Palace Hotel.
JenaValve has commenced a multicenter CE-mark pivotal study to evaluate the safety and effectiveness of its transapical TAVI system. The primary endpoint of the trial is the 30-day mortality rate; secondary endpoints are procedural success, valve performance and safety.
JenaValve has designed two TAVI systems for treating high-risk patients: a transapical (TA) platform for heart surgeons, and a transfemoral (TF) platform for cardiologists. Each of these systems is comprised of three state-of-the-art components: (1) a catheter delivery system; (2) a unique, self-expanding nitinol stent; and (3) a heart valve-the TAprosthesis uses a porcine root valve, while the TF prosthesis is a pericardial tissue construct, allowing for a small catheter diameter. JenaValve expects to enter the European market with its transapical TAVIsystem in early 2011.
Aortic stenosis, the most prevalent heart valve disease in Western countries, is increasing steadily with an aging population. The decision to surgically replace a diseased aortic valve is problematic in elderly patients due to associated high mortality and morbidity risks. In fact, elderly patients with severe aortic disease symptoms are not often considered candidates for surgery. JenaValve's advanced TAVI systems are designed for this type of patient. JenaValve's next-generation TAVIsystems also are designed to enable correct positioning, re-positioning and retrievability for patient safety, and ease-of-handling in order to reduce the long learning curve associated with TAVIdevices now used by physicians.
About JenaValve Technology
JenaValve Technology is a medical device company focused on developing transcatheter valve implantation systems to treat patients suffering from aortic valve disease. The company has transcatheter aortic valve implantation (TAVI) systems for both transapical and transfemoral approaches to address the needs of the cardiac surgeon and cardiologist, respectively.
JenaValve and JenaClip are trademarks of JenaValve Technology GmbH. The JenaValve products are protected by pending and granted patent, design and utility model rights.
