Phoenix Cardiac Devices has announced that it has received CE mark for its Basal Annuloplasty of the Cardia Externally—BACE—device, a novel modality for the treatment of functional mitral regurgitation (FMR).
BACE is the only surgical device with long-term clinical data demonstrating significant benefit by addressing the root cause of FMR, Phoenix Cardiac Devices said in a press release, adding that the CE Mark serves as approval by the European Union (EU) to commercialise BACE. Supporting clinical data, show significant efficacy in reduction of MR grade and size of the left ventricle that was sustained out to 24 months, and will be presented as a late-breaking presentation at the virtual American Association for Thoracic Surgery 101st annual meeting (AATS 2021, April 30–2 May, virtual).
“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,” said Gopal Muppirala, co-founder, president and chief executive officer of Phoenix Cardiac. “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.”
BACE is designed to be less invasive than current treatment protocols of mitral valve repair or replacement because the device sits outside the heart, eliminating the need for open-heart surgery or a cardiac bypass machine, thereby minimising the duration of hospital stays. 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 allows for easy adjustment of the inflatable chambers of the BACE device to ensure optimal fit of the device around the heart immediately post-surgery, while facilitating maintenance of the fit and related efficacy over time.
“The BACE device is a potential game-changer in functional mitral regurgitation, a disease area sorely lacking in innovation since the standard of care was approved more than 50 years ago,” commented Jan Hlavicka, University Hospital Clinic for Cardiovascular Surgery at Göethe University in Frankfurt am Main, Germany, and one of the investigators in the pivotal study supporting the CE mark designation. “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 post-implant, speaks to its considerable promise.”