Phoenix Cardiac Devices, Inc. announced that it has received CE Mark approval for commercialization in Europe of its BACE (“basal annuloplasty of the cardia externally”) device for the treatment of functional mitral regurgitation (MR).
According to the company, the BACE device is supported by long-term clinical data demonstrating a significant benefit by addressing the root cause of functional MR. The data show significant efficacy in reduction of MR grade and size of the left ventricle that was sustained out to 24 months. These findings will be presented as a late-breaking presentation at the 101st annual meeting of the American Association for Thoracic Surgery that will be held virtually on April 30, 2021.
The company stated that additional benefits of the BACE device include:
- No direct contact with blood flow, thus limiting the risk of thrombosis, stroke, and infection that commonly occur with devices implanted within the heart, as well as reducing the need for supporting medications such as anticoagulants
- Real-time assessment of efficacy with an echocardiogram, which allows for easy adjustment of the inflatable chambers of the BACE device to ensure optimal fit of the device around the heart immediately postsurgery, while facilitating maintenance of the fit and related efficacy over time.
Jan Hlavicka, MD, from the University Hospital Clinic for Cardiovascular Surgery at Göethe University in Frankfurt am Main, Germany, served as one of the investigators in the pivotal study supporting the CE Mark designation.
“The BACE device is a potential game-changer in functional MR, a disease area sorely lacking in innovation since the standard of care was approved more than 50 years ago,” commented Dr. Hlavicka in the company’s press release. “BACE can be easily adjusted postoperatively, if necessary, in an outpatient setting without any additional surgery, and does not preclude further valvular intervention if required. The fact that BACE has been implanted in over 60 patients, and that its first recipient has successfully completed 10 years postimplant, speaks to its considerable promise.”