The device allows to avoid direct contact with blood flow and minimise the risk of thrombosis, stroke and infection
Phoenix Cardiac Devices has secured CE mark approval for its Basal Annuloplasty of the Cardia Externally (BACE) device to treat functional mitral regurgitation (FMR).
BACE is claimed to be the only surgical device with long-term clinical data showing significant benefit by addressing the root cause of FMR.
FMR takes place when blood leaks backward through the mitral valve into the left atrium each time the ventricle contracts. It may happen due to abnormal function of the heart muscle.
According to the company, the supporting clinical data demonstrated significant efficacy in the reduction of MR grade and size of the left ventricle, which was sustained out to 24 months.
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 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.”
The BACE device avoids the need for open-heart surgery or a cardiac bypass machine, as it sits outside the heart.
It allows to prevent direct contact with blood flow, thereby helping to minimise the risk of thrombosis, stroke, and infection that commonly occur with devices implanted within the heart.
The device also helps to avoid the use of supporting medications such as anti-coagulants.
In addition, the company is looking for a partner to carry out a pivotal study in pursuit of a heart failure indication.
Founded in 2012, Phoenix Cardiac is engaged in design, development and marketing of new patented technologies in the cardiac medical device field.