Phoenix Cardiac Devices announced that it received CE mark approval for its BACE device for treating functional mitral regurgitation (FMR).
BACE (basal annuloplasty of the cardiac externally) is a novel modality for treating FMR and is touted as the only surgical device with long-term clinical data demonstrating significant benefit by addressing the root cause of FMR, according to a news release.
Cary, N.C.-based Phoenix Cardiac Devices designed BACE to be far less invasive than the current treatment protocols for mitral valve repair or replacement. The device sits outside the heart and eliminates the need for open-heart surgery or a cardiac bypass machine, thus minimizing hospital stay duration, the company said.
Additionally, the device offers no direct contact with blood flow to reduce the risk of thrombosis, stroke and infections that commonly occur with devices implanted within the heart, while it also reduces the need for supporting medications like anticoagulants.
The device offers real-time assessment of efficacy with an echocardiogram, allowing for the easy adjustment of the inflatable chambers of the BACE device that ensures the optimal fit for the device around the heart immediately after surgery, according to the company.
“The CE Mark validates the promise of our BACE device as a safe, less invasive, and cost-effective approach to the potential treatment of functional mitral regurgitation,” Phoenix Cardiac Devices co-founder, president & CEO Gopal Muppirala said in the release. “This important milestone gives Phoenix Cardiac fresh momentum to our efforts to secure a partner for a second clinical study of the BACE device as we pursue a potential indication for heart failure.”