This article is more than 5 years old. Information may no longer be current.

Early feasibility study of next-generation pericardial TAVR system underway

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

An early feasibility study is underway to investigate use of a next-generation pericardial transcatheter aortic valve replacement system for treatment of patients with symptomatic, severe aortic stenosis and aortic regurgitation at extreme or high surgical risk, with the first successful U.S. implantations performed at NewYork-Presbyterian/Columbia University Medical Center and MedStar Washington Hospital Center.

The prospective, single-arm study is being conducted at several centers of excellence in the United States under an FDA-approved investigational device exemption (IDE). The early feasibility study is part of a larger, ongoing CE Mark clinical program that is investigating the system for the same indications at centers in Europe and New Zealand, according to a press release issued by JenaValve Technology, Inc.

“Both myself and my [Columbia University Medical Center] 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.,” Martin B. Leon, MD, professor of medicine at Columbia University Medical Center, director of the Center for Interventional Vascular Therapy, director of the cardiac catheterization laboratories and member of the executive board of the Columbia/NewYork-Presbyterian Heart Valve Center, and founder of the Cardiovascular Research Foundation, stated in the release.

The JenaValve Pericardial TAVR System consists of the Everdur transcatheter heart valve and the Coronatix transfemoral delivery catheter. The system features a self-expanding nitinol stent with a porcine pericardial valve. The 18F-equivalent delivery catheter is designed to deliver the bioprosthesis using a stepped approach with anatomic positioning over the native valve. The system is available in three sizes for aortic annulus diameters from 21 mm to 27 mm. A larger size is in development.

Disclosure: Cardiology Today’s Intervention could not confirm relevant financial disclosures.