Cardiovalve tricuspid valve replacement
Cardiovalve landed FDA breakthrough device designation in February for its transcatheter tricuspid valve replacement system. The agency also approved an early feasibility study of the system for a tricuspid regurgitation (TR) indication.
The company said it developed a transfemoral valve replacement system in which the valve mimics current surgical replacement solutions and is able to fit both mitral and tricuspid indications. The system can cover 90% of the patient population with three approved valve sizes using the same delivery system, according to Cardiovalve officials.