FDA Approves Early Feasibility Study for Anteris Heart Valve System

The FDA has conditionally approved Anteris Technologies’s investigational device exemption (IDE) application for its DurAVR transcatheter heart valve system, opening the door for the company to begin an early feasibility study to treat symptomatic severe native aortic stenosis (AS).

The DurAVR system is a 3D single-piece aortic valve shaped to mimic the human valve. The study will evaluate the safety and efficacy of the system for patients with severe AS, a condition in which the valve between the lower left heart chamber and the aorta is narrowed, reducing or blocking blood flow from the heart. Symptoms of AS include chest pain, fatigue and shortness of breath.

An early feasibility study allows for a limited clinical investigation of a device early in development to support device innovation.