Corvia Atrial Shunt Receives CE Mark Certification Under EU MDR

January 10, 2025—Corvia Medical, Inc. recently announced that it has achieved CE Mark certification for the Corvia atrial shunt system under the European Union Medical Device Regulations—EU MDR 2017/745. The company stated that the device is a catheter-based cardiac implant designed to reduce heart failure (HF) symptoms by lowering pressures in the heart and lungs.

According to the company, the Corvia atrial shunt is designed to alleviate elevated left atrial pressure by creating a controlled passage between the left and right atria.

Approximately 70 sites worldwide are currently participating in the RESPONDER-HF confirmatory randomized clinical trial, which is enrolling HF patients without latent pulmonary vascular disease or pacemakers, who have been shown in previous Corvia trials to experience substantial clinical benefit from shunting, advised Corvia Medical.