Phoenix Cardiac Devices, a healthcare products manufacturer based in Chicago, Illinois, announced that it had successfully launched a trial of its Bace mitral regurgitation device. The clinical trial is part of the company’s strategy to receive CE Mark clearance in the E.U.
According to a press release by the company, the Bace mitral regurgitation device is designed to assist in the repair of leaking heart valves without the need for complex surgeries.
The new clinical trial will comprise patients in both Europe and India. To qualify, patients must be diagnosed with functional mitral regurgitation. Mitral regurgitation is caused when blood flows backward through a patient’s mitral valve. When blood leaks into the atrium through the mitral valve, patients are at an increased risk of heart failure. Traditional treatment options for mitral valve regurgitation require complex open-heart surgery. With the Bace minimally-invasive device, physicians can offer patients a lower-cost treatment that minimizes complications. Early feasibility studies show that the device should not cause adverse events.
Gopal Muppirala is the cofounder and CEO of Phoenix Cardiac Devices. In prepared remarks, he said, "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.”