JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced initiation of patient enrollment in the Early Feasibility Study (EFS) of its next generation JenaValve Pericardial TAVR System using the Everdur™ transcatheter heart valve (THV) and CoronatixTM Transfemoral Delivery Catheter at NewYork-Presbyterian/ Columbia University Medical Center (CUMC), New York City, and MedStar Washington Hospital Center, Washington, DC. The EFS is investigating the JenaValve Pericardial TAVR System for the minimally invasive treatment of patients with symptomatic, severe aortic stenosis (AS) and symptomatic, severe aortic regurgitation (AR) for whom open surgery is an extreme or high risk. The JenaValve Pericardial TAVR System is an investigational device in the United States and internationally.
The EFS is a prospective, single-arm study of the JenaValve Pericardial TAVR System being conducted at several centers of excellence in the United States under an FDAapproved investigation device exemption (IDE). It is part of a larger, ongoing CE Mark clinical program investigating the JenaValve Pericardial TAVR System for the same indications at centers in Europe and New Zealand.
The JenaValve system is proprietary and differentiated from currently available TAVR devices due to the Everdur THV locator-based technology, designed to enable anatomically-correct, predictable implantation using the new 18-Fr equivalent Coronatix Transfemoral Delivery Catheter. Enrollment has been completed for the AS CE Mark clinical program and is ongoing for the AR CE Mark clinical program.
The Executive Chair of the JenaValve Clinical Development Program Dr. Martin Leon (Director of the Center for Interventional Vascular Therapy and Professor of Medicine at CUMC) said, “Both myself and my CUMC colleagues, Dr. Susheel Kodali and Dr. Torsten Vahl, are extremely pleased to be the first U.S. physicians to treat patients with the new JenaValve TAVR system. The first procedures for both AS and AR patients demonstrated the system’s ease of use and potential that the Everdur valve may be an important addition to the transcatheter valve products. In particular, the JenaValve TAVR technology enables TAVR treatment for patients with severe AR who are at increased surgical risk that until now have not had a suitable transcatheter option in the U.S. We look forward to continuing our work with the JenaValve clinical and product development teams to expand the study of its TAVR technology in the U.S.”
“It has been our goal since the early development of our next generation TAVR System to bring this novel technology into the United States,” said JenaValve Chief Executive Officer Victoria Carr-Brendel, PhD. “We are greatly encouraged to initiate enrollment at these prestigious centers under the direction of these physicians, and thank them for their efforts. We will continue to work tirelessly with our clinical partners to expand patient enrollment at new clinical sites in the United States.”
The Company is seeking FDA approval for expanded IDE access to patients at the top clinical centers in the U.S.