Another company is trying its hand at the emerging transcatheter mitral valve replacement space – which could someday outpace TAVR. OR Yehuda, Israel-based Cardiovalve said it has commenced the AHEAD US Multicenter Study, which will test the safety and feasibility of the firm’s device in reducing mitral regurgitation. Trial recruitment will start in early 4Q18.
The news came at the start of the Transcatheter Cardiovascular Therapeutics conference, being held in San Diego now and set to conclude Tuesday. Details of the first-in-human Cardiovalve procedure with the transfemoral mitral valve system will be presented by Cardiovalve Chief Medical Director, Prof. Francesco Maisano of the University Hospital Zurich, during TCT.
"The transfemoral approach to implantation was very straightforward, controlled and reassuring,” Maisano said in a release. “I believe that ultimately, Cardiovalve will change how mitral valve replacement is practiced in the clinical setting."
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.
Recently, Abbott Laboratories, a key participant in the TMVR M&A spree of 2015, announced it had initiated SUMMIT, a pivotal trial of its mitral valve system.