Corvia Medical Earns CE Certification for Innovative Atrial Shunt System in Europe

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

In a significant advancement for heart failure treatment, Corvia Medical, Inc., based in Tewksbury, Massachusetts, has proudly announced that it has secured CE certification for the Corvia® Atrial Shunt System. This certification aligns with the newly implemented EU Medical Device Regulations (EU MDR 2017/745), setting a benchmark for safety and efficacy in medical devices.

The Corvia Atrial Shunt is a catheter-based cardiac implant designed to enhance the quality of life for individuals suffering from heart failure by targeting and reducing elevated pressures in the heart and lungs. With heart failure affecting over 26 million people globally, and a substantial segment of these cases—about half—experiencing heart failure with preserved ejection fraction (HFpEF), innovative treatment options are critical. Patients with HFpEF often cope comfortably while at rest but struggle with breathlessness during physical activity, complicating their daily lives.

The design of the Corvia Atrial Shunt aims to alleviate symptoms associated with high left atrial pressure (LAP), which is a primary contributor to heart failure symptoms. By establishing a controlled passage between the left and right atria, the device effectively lowers LAP, allowing for better management of heart failure symptoms.

Currently, the company is conducting the RESPONDER-HF clinical trial, a pivotal study that involves approximately 70 research sites across the globe. This randomized confirmatory trial is enrolling patients who exhibit heart failure but do not have underlying pulmonary vascular disease or pacemakers. Previous trials have indicated that patients undergoing shunting have reported remarkable clinical improvements.

Kate Stohlman, the Vice President of Quality and Regulatory Affairs at Corvia Medical, emphasized the importance of this achievement, stating, "The CE Mark under the MDR for an implantable therapeutic cardiac device with the strictest requirements is a significant milestone for 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, continuously adhering to regulatory guidelines."

Founded in 2009, Corvia Medical is committed to redefining the treatment paradigm for heart failure. The company focuses on developing cutting-edge transcatheter cardiovascular devices that help patients regain control of their lives. Marking its excellence, the Corvia Atrial Shunt was awarded Breakthrough Device designation by the FDA in 2019, solidifying its promise in the field.

Corvia Medical operates with the backing of various prominent investors, including Third Rock Ventures, General Catalyst Partners, and Edwards Lifesciences, alongside an undisclosed strategic investor. Joe Hine, Director of Global Marketing, stated, "With this certification, we are excited to launch our innovation in heart failure treatment across Europe, providing new possibilities for patients who currently face limited treatment options."

As the RESPONDER-HF trial progresses, interested healthcare professionals can find referral and enrollment information at the official Corvia Medical website. This journey marks a promising evolution in the pathway of heart failure management and reflects a strong commitment to enhancing patient outcomes through innovative medical solutions.

For more details, visit Corvia Medical's website.

Media Contact:
Lisa Ensz
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