Corvia Medical said today that it landed CE Mark approval in the European Union for its InterAtrial Shunt device for treating a type of heart failure.
The IASD is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria. It’s indicated for diastolic heart failure, also known as heart failure with preserved ejection fraction.
Tewksbury, Mass.-based Corvia also said that its 100-patient Reduce Lap-HF I study, run under an investigational device exemption from the FDA, enrolled its 1st patients at Ohio State University’s Richard Ross Heart Hospital.
“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 innovative technology to the millions of patients who suffer from heart failure,” president & CEO George Fazio said in prepared remarks. “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,”
“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,” added Dr. Rami Kahwash, principal investigator in the Reduce LAP-HF study. “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.”
Corvia said subjects in the 64-patient study that backed its CE Mark bid, published in March issue of The Lancet, showed improvements in both their New York Heart Assn. scores and their ability to exercise. Patients improved their median NYHA scores from class 3 to class 2 and reported improved quality of life scores using the Minnesota Living with Heart Failure questionnaire (the mean score improved from 49 to 36, the company said).
Six-minute walk distance improved from a mean of 313 meters to 345 meters, with mean exercise duration rising from 7.3 minutes to 8.2 minutes, Corvia said.
Last September the company drummed up a $34 million equity round from 9 unnamed investors. Corvia, formerly known as DC Devices, closed a $10.7 million funding round in March 2013 and added another $34 million in a Series D round in July 2014.