Phoenix Cardiac Devices has obtained CE Mark for its novel Basal Annuloplasty of the Cardia Externally (BACE) device for treating functional mitral regurgitation (FMR).
Phoenix Cardiac claim that BACE is the only surgical device with significant benefits from addressing the root cause of FMR that are demonstrated by long-term clinical data.
The latest development serves as approval by the European Union (EU) for the commercialisation of BACE.
The clinical data supporting the CE Mark approval demonstrated significant efficacy, which was sustained for 24 months, in lowering the mitral regurgitation (MR) grade and size of the left ventricle.
Phoenix Cardiac co-founder, president and CEO Gopal Muppirala said: “The CE Mark validates the promise of our BACE device as a safe, less invasive and cost-effective approach to the potential treatment of FMR.
“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 compared to the existing treatment protocols of mitral valve repair or replacement. As it is positioned outside the heart, it eradicates the need for open-heart surgery or a cardiac bypass machine, thereby reducing hospital stay time.
Furthermore, the BACE device makes no direct contact with blood flow, which lowers the risks of thrombosis, stroke and infection which usually happen when devices are implanted within the heart. It can also cut down on requirements for supporting medications, such as anticoagulants.
FMR occurs as a result of abnormal function of the heart muscle. When the ventricle contracts, blood leaks backwards through the mitral valve into the left atrium.
This causes high blood volume and pressure in the left atrium, which leads to damming of blood in the lungs. This then causes shortness of breath and other debilitating symptoms.