Cardiovalve (Or Yehuda, Israel) said today that U.S. FDA has granted a breakthrough device designation for its transcatheter tricuspid valve replacement system.
FDA also approved an early feasibility study of the system for a tricuspid regurgitation (TR) indication.
Cardiovalve touted that it is the first privately held company to have the FDA early feasability study approval for both TR and MR (tricuspid/mitral regurgitation) indications.
Cardiovalve has developed a transfemoral valve replacement system in which the valve mimics current surgical replacement solutions. It is able to fit both mitral and tricuspid indications. Cardiovalve officials say the system is able to cover 90% of the patient population with three approved valve sizes, using the same delivery system.
“I have previously successfully performed initial first-in-human cases with the Cardiovalve MR procedure. Now, the Cardiovalve system can be utilized in the tricuspid location with the same transcatheter procedure. In fact, the Tricuspid is simpler and faster and, therefore, I anticipate similar procedural success,” Dr. Francesco Maisano, head of cardiovascular surgery at Zurich University Hospital in Switzerland, said in a news release.
Cardiovalve CEO Amir Gross praised FDA recognition of the potential benefits 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,” Gross said. “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.”