Phoenix Cardiac Devices Earns CE Mark for Functional Mitral Regurgitation Treatment

Phoenix Cardiac has been granted a CE mark for its BACE (Basal Annuloplasty of the Cardia Externally) surgical device, a treatment for functional mitral regurgitation (FMR).

The device consists of a silicone band assembly with inflatable silicone chambers and small belt loops of polyester. Positioned around the base of the heart, the device removes the need for open-heart surgeries or cardiac bypass machines. It can also be adjusted postoperatively in outpatient settings without additional surgery.

The BACE device does not directly contact blood flow, limiting the risk of thrombosis, stroke and infections that can occur from devices implanted inside the heart.