Phoenix Cardiac Devices initiated a clinical trial of its Bace mitral regurgitation device, designed to repair leaky heart valves without open-heart surgery.
The 60-patient study will enroll subjects in India and Europe who are suffering moderate to severe functional mitral regurgitation, according to a press release. The trial is aimed at winning CE Mark approval in the European Union.
""The current standard of care was developed nearly 40 years ago and, with the advances in technology, there is both an opportunity and a critical need for less invasive and more effective treatments," CEO & co-founder Gopal Muppirala said in prepared remarks.
Mitral regurgitation results from the leakage of blood backward into the left atrium through the mitral valve and can lead to congestive heart failure, according to the release.
Muppirala said the Bace device is a less-invasive, lower-cost treatment for mitral regurgitation that reduces complications and the risk of mortality compared with open heart surgery.
Small proof-of-concept and feasibility studies showed that the Bace device could reduce the mitral regurgitation without adverse events, according to the release.