Cardiovalve has a pair of milestones that could help catapult the company into the forefront of the tricuspid valve market. The Or Yehuda, Israel-based company received FDA approval for an early feasibility study of the transcatheter tricuspid valve replacement system and Breakthrough Device Designation for the technology.
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 leading US hospitals.
In a release Cardiovalve’s CEO Amir Gross, CEO 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."
Cardiovalve isn’t the only company that has made significant strides in the tricuspid valve space. In September of last year, Abbott Laboratories had a significant milestone in space by nabbing an IDE for the TriClip from FDA. Abbott's IDE study is set to enroll 700 patients in centers in the U.S., Canada, and Europe. Patients in the trial will be randomized to receive either the TriClip device or medical therapy and followed for a total of five years. The study will also have a single arm for the treatment of subjects with more complex tricuspid valve disease.
Cardiovalve isn’t just focused on the tricuspid valve. The firm is also working on solutions for the mitral valve. In 2018, the company initiated the AHEAD US Multicenter Study, which will test the safety and feasibility of the firm’s device in reducing mitral regurgitation.
Cardiovalve was originally a part of Valtech Cardio, a company acquired by Edwards Lifesciences for $340 million and up to $350 million in milestone payments. Irvine, CA-based Edwards picked up the company to bolster its mitral and tricuspid valve offerings. The deal came about two years after a wave of acquisitions in the TMVR space by many of the larger medtech companies.