JenaValve Initiates Enrollment for Early Feasibility Study in the United States
August 3, 2018—JenaValve Technology, Inc. announced initiation of patient enrollment in the early feasibility study (EFS) of the next-generation JenaValve pericardial transcatheter aortic valve replacement (TAVR) system. The first patients were enrolled at NewYork-Presbyterian/Columbia University Medical Center in New York, New York, and MedStar Washington Hospital Center in Washington, DC. Martin Leon, MD, who is Director of the Center for Interventional Vascular Therapy and Professor of Medicine at Columbia, serves as Executive Chair of the JenaValve Clinical Development Program.
According to the company, the EFS is a prospective, single-arm study investigating the JenaValve pericardial TAVR system for the minimally invasive treatment of patients with symptomatic, severe aortic stenosis and symptomatic, severe aortic regurgitation who are at extreme or high risk for open surgery.
The JenaValve pericardial TAVR system uses the company's Everdur transcatheter heart valve, which is designed with locator-based technology to enable anatomically correct, predictable implantation using the new 18-F–equivalent Coronatix transfemoral delivery catheter. The JenaValve pericardial TAVR system is an investigational device in the United States and internationally.
The study is being conducted at several centers of excellence in the United States under an FDA-approved 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. Enrollment has been completed for the aortic stenosis CE Mark clinical program and is ongoing for the aortic regurgitation CE Mark clinical program.
Additionally, the company is seeking FDA approval for expanded IDE access to patients at the top clinical centers in the United States.