Corvia Medical Achieves CE Certification for Atrial Shunt Under New EU MDR Standards

TEWKSBURY, Mass., Dec. 20, 2024 /PRNewswire/ -- Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure, announced today that it has achieved CE certification for the Corvia® Atrial Shunt System under the latest EU Medical Device Regulations (EU MDR 2017/745).

The Corvia Atrial Shunt is a catheter-based cardiac implant designed to reduce heart failure symptoms by lowering pressures in the heart and lungs.

Heart failure (HF) affects over 26 million people worldwide, with more than half experiencing heart failure with preserved ejection fraction (HFpEF), a condition in which patients are comfortable at rest but become immediately breathless with any exertion. Treatment options are limited.

The Corvia Atrial Shunt is designed to alleviate elevated left atrial pressure (LAP) — a primary driver of HF symptoms — by creating a controlled passage between the left and right atria. Some 70 study sites worldwide are currently participating in RESPONDER-HF, a confirmatory, randomized clinical trial 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.

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