JenaValve Technology has started the recruitment of patients in the early feasibility study (EFS) of its next generation transcatheter aortic valve replacement (TAVR) system to treat severe aortic stenosis (AS) and severe aortic regurgitation (AR)
The firm is enrolling patients in the study of its JenaValve pericardial TAVR system by using the Everdur transcatheter heart valve (THV) and Coronatix transfemoral delivery catheter at NewYork-Presbyterian/ Columbia University Medical Center (CUMC), New York City, and MedStar Washington Hospital Center, Washington, DC.
JenaValve Pericardial TAVR System is an investigational device in the US and across the globe.
JenaValve pericardial TAVR system is being assessed for the minimally invasive treatment of patients with symptomatic and severe AS, as well as symptomatic and severe AR for whom open surgery is an extreme or high risk.
The EFS is a prospective and single-arm study of the next-generation TAVR System, which is being carried out under an FDA-approved investigation device exemption (IDE).
It is also a part of the ongoing CE mark clinical program studying the JenaValve pericardial TAVR system for the same indications at centers in Europe and New Zealand.
JenaValve CEO Dr Victoria Carr-Brendel said: “It has been our goal since the early development of our next generation TAVR System to bring this novel technology into the United States.
“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.”
JenaValve system features Everdur THV locator-based technology, which allows anatomically-correct and predictable implantation with the support of new 18-Fr equivalent Coronatix transfemoral delivery catheter.
The bioprosthesis includes self-expanding nitinol stent with a porcine pericardial valve produced by using advanced processing techniques.
Coronatix transfemoral delivery catheter will deliver the bioprosthesis by using a simple stepped approach with anatomic positioning over the native valve. It is provided in three sizes to support aortic annulus diameters from 21mm to 27mm.
JenaValve Technology is engaged in the development, manufacturing and marketing of advanced TAVR systems to treat patients suffering from aortic valve disease.