May 12, 2016
CE Mark Approved for Corvia Medical's Atrial Decompression System
May 12, 2016—Corvia Medical, Inc. announced European CE Mark approval of the company’s transcatheter interatrial shunt device (IASD), the Corvia atrial decompression system. The device is designed to treat heart failure with preserved ejection fraction (HFpEF).
With the aim of lowering left atrial pressure, the IASD implant is deployed through an opening in the atrial septum, forming a passage between the left and right atria that enables the left atrium to decompress at rest and physical activity. 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.
In Corvia’s announcement, Prof. David Muller, MD, the Director of Cardiac Catheterization at St. Vincent's Hospital in Sydney, Australia, commented, “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.” Prof. Muller added, “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.”
European CE Mark approval of the device was supported by the results of the 64-patient REDUCE LAP-HF trial. In March, Prof. Gerd Hasenfuß, MD, et al published the results of the REDUCE LAP-HF trial in The Lancet (2016;387:1298–1304).
According to Corvia, the trial showed that after 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 6-months postimplantation, median New York Heart Association functional class improved from 3 to 2 (P < .0001), mean quality-of-life measurement (Minnesota Living with Heart Failure questionnaire) improved from 49 to 36 (P < .0001), mean 6-minute walk distance improved from 313 meters to 345 meters (P = .0023), and mean exercise duration improved from 7.3 min to 8.2 min (P = .0275). Device patency was sustained at 6 months.
The company also announced that the first patients have been enrolled in the follow-up REDUCE LAP-HF I trial. The prospective, multicenter, randomized controlled study will evaluate the IASD in patients at up to 20 sites in the United States and up to 8 sites outside the United States. Corvia’s IASD is not available for commercial distribution in the United States, advised the company.
The first United States patient in the trial was enrolled by Principal Investigator Rami Kahwash, MD, who is a heart failure cardiologist at the Ohio State University Richard M. Ross Heart Hospital in Columbus, Ohio.
Dr. Kahwash stated in the Corvia press release, “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. I have performed thousands of 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.”