JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced initiation of patient enrollment and implantations associated with the CE Mark study of its next generation JenaValve Pericardial TAVR System using the Coronatix Transfemoral Delivery Catheter for the percutaneous treatment of patients with symptomatic, severe aortic regurgitation (AR). The JenaValve Pericardial TAVR System is an investigational device in the United States and internationally.

The CE Mark study is an international, prospective, non-randomized, single-arm trial of the JenaValve Pericardial TAVR System for the treatment of AR in patients who are at increased risk for conventional surgical valve replacement.

The JenaValve system is proprietary and differentiated from currently available TAVR devices due to the Everdur™ locator-based technology, designed for more predictable implantation using the new 18-Fr equivalent Coronatix Transfemoral Delivery Catheter. The optimized TAVR system has now been used to treat several AR patients in Germany.

The national Principal Investigator, Prof. Dr. med. Stephan Baldus (Heart Center of the University of Cologne), said, “There is currently no TAVR treatment for severe aortic regurgitation cleared by regulators. These patients do not typically develop calcification at the implant site, so other TAVR valves that rely on this narrowing to anchor their devices are at risk of migration. The JenaValve transcatheter valve may address this issue by securing the device with three novel locators that grasp the native valve leaflets. We have just begun study enrollment and treatment with this innovative transcatheter heart valve which has demonstrated low pressure gradients, no new pacemaker implantations and no paravalvular leak.”

“Our goal is to enable the treatment of patients with severe aortic regurgitation while avoiding many of the sideeffects with off-label use of other TAVR devices in this patient population,” said JenaValve Chief Executive Officer Victoria Carr-Brendel, PhD. “We are excited to initiate this trial and look forward to expanding enrollment across multiple sites, building on this positive initial experience with our partners at the Heart Center of the University of Cologne.”

The Company expects to complete patient enrollment by the end of 2018 at clinical sites in Germany, The Netherlands, New Zealand and the United States. The Company anticipates CE Mark approval for treating patients with severe aortic regurgitation by the second half of 2019. The Company completed patient enrollment in a CE Mark study of the JenaValve Pericardial TAVR System for the percutaneous treatment of severe aortic stenosis and expects approval before the end of 2018.

 

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