The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Israel-based medical device company Cardiovalve’s Transcatheter Tricuspid Valve Replacement System for tricuspid regurgitation (TR) indication.
The regulatory agency also approved an Early Feasibility Study (EFS) of the Cardiovalve Transcatheter System.
Cardiovalve is the first privately held company to receive the FDA’s EFS approval for both tricuspid (TR) and mitral regurgitation (MR) indication.
Cardiovalve CEO Amir Gross 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.”
Earlier this year, the company started the early feasibility study for TR in the US. The primary endpoint of the study is the safety and feasibility of the Cardiovalve technology and procedure in reducing tricuspid regurgitation.
The study, conducted in partnership with five prominent US hospitals, includes evaluations at 30 days and periodically up to five years.
The firm’s transfemoral valve replacement system has a valve that mimics current surgical replacement solutions to fit both mitral and tricuspid indications, covering 90% of the patient population with three approved sizes, using the same delivery system.
New York-based Montefiore Medical Center’s Department of Cardiology medical director of structural heart interventions Dr Azeem Latib, is the primary investigator of the study.