Cardiovalve has received U.S. Food and Drug Administration (FDA) approval for an Early Feasibility Study (EFS) of its Transcatheter Tricuspid Valve Replacement System for a tricuspid regurgitation (TR) indication.

The Cardiovalve System also has been granted ‘Breakthrough Device Designation’ status by the FDA.

Cardiovalve has developed a transfemoral valve replacement system where the valve mimics current surgical replacement solutions that can fit both mitral and tricuspid indications, covering 90% of the patient population with three approved valve sizes, using the same delivery system.

Dr. Azeem Latib, medical director of structural heart interventions at Montefiore Medical Centre’s Department of Cardiology in New York City, said: “I am excited to finally have a truly percutaneous approach for treating TR. The Cardiovalve System is an innovative solution for an unmet clinical need."

Cardiovalve commenced its Early Feasibility Study for TR in the U.S. earlier this year. The study’s primary endpoint is the safety and feasibility of the Cardiovalve technology and procedure in reducing tricuspid regurgitation, with evaluations at 30 days and periodically up to five years. The study will be conducted in collaboration with five US hospitals.

Amir Gross, CEO of Cardiovalve, said: "We are excited about the FDA’s recognition of the potential clinical benefit of the Transcatheter Tricuspid Valve Replacement System. We now have clinical data two years out that our implant is functioning as expected and the patient is improved clinically. FDA’s ‘breakthrough’ designation validates and reaffirms our commitment to improving and extending the lives of millions of patients suffering from heart valve disease across the world."