JenaValve Technology is continuing to make progress in bringing its transcatheter aortic valve replacement (TAVR) system to the U.S. market. The Irvine, CA-based company has initiated patient enrollment in an early feasibility study (EFS) of its next generation JenaValve Pericardial TAVR system.
The EFS is a prospective, single-arm study of the JenaValve Pericardial TAVR System being conducted at several centers U.S. under an FDA-approved 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.
“It has been our goal since the early development of our next generation TAVR System to bring this novel technology into the United States,” JenaValve CEO Victoria Carr-Brendel, PhD, said in a release. “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 U.S.”
The company is seeking FDA approval for expanded IDE access to patients at the top clinical centers in the U.S.
The JenaValve Pericardial TAVR System consists of the Everdur Pericardial Aortic Valve (manufactured at the JenaValve England facility) and the Transfemoral Delivery System. The bioprosthesis comprises a self-expanding nitinol stent with a porcine pericardial valve manufactured using tissue processing techniques.
The Coronatix transfemoral delivery catheter is designed to deliver the bioprosthesis using a simple stepped approach with anatomic positioning over the native valve. The System is available in three sizes intended for aortic annulus diameters from 21mm to 27mm. A larger bioprosthesis size is in development.
In June, JenaValve said it had implanted the initial patients in a CE mark study for the treatment of severe AR.
There are a growing number of players either emerging or making their mark in the TAVR space. One of the latest firms is Meril Lifesciences. The company is taking a different route than other TAVR companies and said in July it was initially focused on bringing its technology to emerging markets.
Edwards Lifesciences and Medtronic rule the TAVR roost, being the only two companies to have garnered FDA approval in the U.S.