Commercial validation in Europe parallels ongoing RESPONDER-HF clinical trial
TEWKSBURY, Mass., Dec. 21, 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.
“The CE Mark under the MDR for an implantable therapeutic cardiac device with the strictest requirements is a significant milestone for Corvia Medical” said Kate Stohlman, VP of Quality and Regulatory Affairs at Corvia Medical. “This approval reflects the dedication, commitment and efforts of our entire global team to the highest levels of device safety and clinical performance, and to continuously meet the requirements of the regulatory authorities.”
About Corvia Medical, Inc.
Corvia Medical, Inc. is revolutionizing the treatment of heart failure through novel transcatheter cardiovascular devices. Founded in 2009 and headquartered in Tewksbury, MA, Corvia is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim their lives. The Corvia Atrial Shunt was granted Breakthrough Device designation by the FDA in 2019. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences, and an undisclosed strategic investor. For more information visit visit us.corviamedical.com. Physician referral/enrollment information for the RESPONDER-HF trial can be found at https://us.corviamedical.com/healthcare-professionals/reduce-lap-hf-clinical-program/responder-hf/
MEDIA CONTACT:
Lisa Ensz
+1 978-654-6120
lensz@corviamedical.com
Source : Corvia Medical Achieves CE Certification for Atrial Shunt Under New EU MDR Standards
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