JenaValve has announced initiation of patient enrolment in its early feasibility study (EFS) of its next-generation JenaValve pericardial transcatheter aortic valve implantation (TAVI) system using the Everdur device and Coronatix transfemoral delivery catheter at NewYork-Presbyterian/ Columbia University Medical Center (CUMC), New York City, and MedStar Washington Hospital Center, Washington, DC (both USA).
A press release reports that the study is investigating the JenaValve system for the minimally invasive treatment of patients with symptomatic, severe aortic stenosis and symptomatic, severe aortic regurgitation for whom open surgery is an extreme or high risk. The feasibility study is a prospective, single-arm study of the system being conducted at several centres of excellence in the USA under an FDA-approved investigation device exemption (IDE). It is part of a larger, ongoing CE Mark clinical program investigating the system for the same indications at centres in Europe and New Zealand.
According to the press release, the JenaValve system is proprietary and differentiated from currently available TAVI devices due to the Everdur valve locator-based technology—designed to enable anatomically-correct, predictable implantation using the new 18Fr equivalent Coronatix transfemoral delivery catheter. Enrolment has been completed for the aortic stenosis CE mark clinical programme and is ongoing for the aortic regurgitation CE mark clinical programme.
The executive chair of the JenaValve clinical development programme Martin Leon (CUMC, New York, USA) says: “Both myself and my CUMC colleagues, Susheel Kodali and Torsten Vahl, are extremely pleased to be the first US physicians to treat patients with the new JenaValve TAVI system. The first procedures for both aortic stenosis and aortic regurgitation 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 TAVI technology enables TAVI treatment for patients with severe aortic regurgitation who are at increased surgical risk that until now have not had a suitable transcatheter option in the USA. We look forward to continuing our work with the JenaValve clinical and product development teams to expand the study of its TAVI technology in the USA.”
JenaValve chief executive officer Victoria Carr-Brendel, comments: “It has been our goal since the early development of our next generation TAVI system to bring this novel technology into the USA. We are greatly encouraged to initiate enrolment at these prestigious centres 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 enrolment at new clinical sites in the USA.”