Phoenix Cardiac gains CE Mark for “game-changer” MR device
Phoenix Cardiac Devices have received CE Mark certification for its BACE (basal annuloplasty of the cardia externally) 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, and has been designed to be less invasive than current treatment protocols of mitral valve repair or replacement.
The device sits outside of the heart eliminating the need for open-heart surgery or a cardiac bypass machine, thereby minimising the duration of hospital stays.
Gopal Muppirala, co-founder, President and Chief Executive Officer of Phoenix Cardiac, 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 functional mitral regurgitation.
“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.”
Additionally, the BACE device includes 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 anti-coagulants.
FMR occurs when blood leaks backward through the mitral valve into the left atrium each time the ventricle contracts, due to abnormal function of the heart muscle. This leads to increased blood volume and pressure in the left atrium and results in a damming of blood in the lungs, causing shortness of breath and other debilitating symptoms.
To maintain forward blood flow, the ventricle must pump harder, leading to enlargement of the left ventricle, setting in motion the progressive downward spiral toward serious and potentially life-threatening complications such as congestive heart failure.
Currently, there are no specific devices to address FMR which affects more than 2% of the global population, including approximately five in 10,000 individuals in the United States, and has a prevalence that increases with age.
The supporting clinical data for the device showed significant efficacy in reduction of mitral regurgitation grade and size of the left ventricle that was sustained out to 24 months.
One of the researchers involved with the CE Mark application study, Jan Hlavicka, PhD, from the University Hospital Clinic for Cardiovascular Surgery at Göethe University in Frankfurt, said: “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.
“BACE can be easily adjusted post-operatively, 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.”
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