Corvia Medical, Inc., a company dedicated to transforming heart failure treatment, recently announced that it has obtained certification under the latest European Union Medical Device Regulation (EU MDR 2017/745).CE Certification of the Corvia® Atrial Shunt System. The Corvia atrial shunt is a catheter-based cardiac implant designed to reduce heart failure symptoms by lowering pressure in the heart and lungs.

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

Corvia Atrial Shunt Procedure Aims to Relieve Elevated Left Atrial Pressure (LAP) – a Primary Driver of HF Symptoms – by Creating a Controlled Channel Between the Left and Right Atria. Globally, Approximately 70 Research Sites 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 Derive Significant Clinical Benefits from the Shunt.

"According to the MDR, obtaining the CE mark for implantable therapeutic cardiac devices with the strictest requirements is a significant milestone for Corvia Medical," said Kate Stohlman, Vice President of Quality and Regulatory Affairs at Corvia Medical. "This approval reflects our entire global team's dedication, commitment, and effort toward the highest levels of device safety and clinical performance, continuously meeting the demands of regulatory authorities."

About Corvia Medical, Inc.

Corvia Medical, Inc. is revolutionizing heart failure treatment with novel transcatheter cardiovascular devices. Founded in 2009 and headquartered in Tewksbury, Massachusetts, Corvia is dedicated to transforming the standard of care for heart failure treatment, enabling patients to regain their quality of life.Corvia Atrial Shunt Granted FDA Breakthrough Device Designation in 2019。

The company is a privately held company supported by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences, and an undisclosed strategic investor.