European Regulators Approve Corvia Medical’s InterAtrial Shunt Device

Corvia Medical Inc., a privately-held company that has developed a first-in-class structural heart device to treat heart failure, has received CE Mark approval of its InterAtrial Shunt Device (IASD). The product is billed as the world’s first transcatheter device designed to treat heart failure with preserved ejection fraction (HFpEF), previously called diastolic heart failure.
 
“I see many patients with HFpEF, and St. Vincent’s was a key contributor to the trial that provided the clinical data to support the successful CE Mark application,” said Prof. David Muller, director of cardiac catheterization at St. Vincent’s Hospital in Sydney, Australia. “Patients with HFpEF have waited many years for an effective treatment, and the CE Mark ensures availability of a treatment that provides hope to a large group of heart failure patients.”
 
The results of the 64-patient CE Mark study, the Reduce LAP-HF Trial, showed that following IASD implantation, patients had significantly fewer heart failure symptoms and were able to exercise significantly longer, resulting in a substantially better quality of life. At six months post-implantation, median New York Heart Association functional class improved from 3 to 2 (p<0.0001), mean quality of life measurement (Minnesota Living with Heart Failure questionnaire) improved from 49 to 36 (p<0.0001), mean six-minute walk distance improved from 313 meters to 345 meters (p=0.0023) and mean exercise duration improved from 7.3 minutes to 8.2 minutes (p=0.0275). Device patency (blood flow from the left to right atria) was sustained at six months.
 
The company also announced that the first group of patients have been enrolled in the follow-on Reduce LAP-HF I Trial, a prospective, multicenter, randomized controlled study to evaluate the IASD in patients at up to 20 sites in the United States and up to eight sites outside the United States.
 
Dr. Rami Kahwash, heart failure cardiologist and principal investigator at the Ohio State University Richard M. Ross Heart Hospital, randomized the first patient in the United States. “Finding new and effective treatment options for patients with HFpEF is crucial because none of the therapeutic treatments that work for systolic heart failure are effective for HFpEF,” Kahwash said. “I have performed thousands of RHCs [right heart catheterizations] on patients with HFpEF only to prove the diagnosis and then walk away with nothing to offer them. This has made me very committed to finding hope for these patients and that is what I see in this trial.”
 
“We are very excited with the start of the randomized study and expect enrollment to progress quickly with the world-class U.S. and international sites that are participating,” said George Fazio, president and CEO of Corvia Medical. “CE mark approval is a significant milestone for Corvia as it sets the groundwork for our reimbursement and brings us one step closer to bringing our technology to the millions of patients who suffer from heart failure.”
 
The InterAtrial Shunt Device (IASD), also known as the Corvia Atrial Decompression System, is the world’s first transcatheter device approved in the European Union to treat heart failure with preserved or mildly reduced ejection fraction (HFpEF). After creating a small opening in the atrial septum, the IASD implant is deployed, forming a passage between the left and right atria that enables the left atrium to decompress at rest and physical activity, with the aim of lowering left atrial pressure. By facilitating continuous and dynamic decompression of the left atrium, the IASD aims to improve heart failure symptoms and quality of life, decrease heart failure hospitalization rates, and reduce the overall cost burden of managing heart failure patients
 
The IASD is not available for commercial distribution in the United States.

Corvia Medical is based in Tewksbury, Mass.