Corvia Medical Announces CE Mark Approval Under MDR for Corvia Atrial Shunt, the First Transcatheter Device for Heart Failure Treatment in HFpEF/HFmrEF Patients

Dec 21, 2024 22:15 CST Updated 22:15

Corvia

Medical Device Development and Manufacturing

Corvia MedicalAnnouncing its atrial shunt device---CorviaCE Approved for Marketing to Alleviate Heart Failure Symptoms by Reducing Pressure in the Heart and Lungs.

Executive Evaluation

"Obtaining the CE mark under the MDR for implantable cardiac treatment devices with the strictest requirements is an important milestone for Corvia Medical.""This approval reflects our entire global team's dedication, commitment, and effort to the highest levels of device safety and clinical performance, as well as continuously meeting the requirements of regulatory authorities."

---Kate Stohlman Vice President of Quality and Regulatory Affairs at Corvia Medical

Heart failure (HF) affects more than 26 million people worldwide, with over half suffering from heart failure with preserved ejection fraction (HFpEF), a condition in which patients feel comfortable at rest but immediately experience shortness of breath upon exertion.Limited treatment options.

CorviaAimed at relieving elevated left atrial pressure (LAP) — a primary driver of heart failure symptoms — by creating a controlled channel between the left and right atria. CurrentlyApproximately 70 research centers worldwide are currently participating in the RESPONDER-HF clinical study, a confirmatory randomized clinical trial enrolling heart failure patients without underlying pulmonary vascular disease or pacemakers. Previous Corvia clinical studies have shown that these patients achieved significant clinical benefits from shunting.

Corvia atrial shunt

Corvia atrial shuntIt is a heart failure treatment product via the femoral vein and atrial septum.Corvia atrial shuntIs a coin-sized implant that is inserted during minimally invasive surgery, designed to create a channel between the left and right atria. By allowing the left atrium to decompress,Corvia atrial shuntCan address elevated pressures that cause heart failure symptoms。Corvia atrial shuntConsists of two parts: the implant and the delivery system;

The implant is a self-expanding metal cage-like device with a dual-disc design and a central opening. The implant is radiopaque and provides ultrasound feedback, allowing it to be visualized through imaging during the implantation process. Each side of the implant has nine legs, with the LA side featuring radiopaque markers at the end of each leg. The LA side of the implant is flat to allow the legs to lie flush with the LA wall, minimizing the LA profile when the implant is deployed. The right atrial side is curved to accommodate variable septal wall thickness, with only the leg tips contacting the right atrial wall. When fully expanded, the outer diameter of the implant is 19.4mm and the inner diameter is 8mm.

Corvia atrial shuntDemonstration

Corvia atrial shunt

Corvia MedicalA company dedicated to revolutionizing the treatment of heart failure by developing groundbreaking structural heart devices. Corvia atrial shuntIs the world's first company approved by the EU for the use of transcatheter devices in the treatment of heart failure, used for HFpEF or HFmrEF. CurrentlyCorvia atrial shuntHas already received FDA approval to conduct PMA-related clinical research in the United States.