Two major medical societies will jointly pursue clinical trials designed to find broader uses for transcatheter aortic valve replacement. And market leader Edwards Lifesciences ($EW), maker of the Sapien TAVR heart valve, will help fund their efforts, according to Forbes, which elaborates on the news first reported by The Gray Sheet.
The American College of Cardiology's and the Society of Thoracic Surgeons' entrance into clinical trials is noteworthy. According to Forbes, they've obtained an FDA investigational device exemption for one trial and are pursuing IDE status for two or more clinical efforts down the line.
"This is the first time the societies have ever filed for an investigational device exemption," former ACC president Ralph Brindis is quoted as saying. "The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients."
According to Forbes, STS president Michael Mack told The Gray Sheet (a subscription-only publication) that the first trial will look at alternatives to transfemoral approaches in 1,000 patients who couldn't otherwise have aortic valve surgery. There was a coordinated effort to develop a trial protocol, worked out between the CACC, STS, CMS, Edwards and the FDA. Expanded uses require an FDA label, he noted, and the only way to do that is to conduct a clinical trial with an IDE in hand.
So why would expanded TAVR uses be necessary? Well, the procedure has become very much in demand, and physicians already began pursuing off-label uses once they learned the initial TAVR procedure, Brindis told Forbes. The magazine notes that the entrance of both the STS and ACC into TAVR clinical trials greatly expands the TVT registry that they run, which tracks TAVR use in the United States to help physicians comply with Medicare's National Coverage Decision for TAVR.
TAVR is indeed a hot space. St. Jude Medical ($STJ) won a CE mark for its Portico transcatheter heart valve late last fall, and Edwards' Sapien competes with Medtronic's ($MDT) CoreValve in Europe. And smaller companies such as Micro Interventional Devices are working hard to develop surgical tools designed to enable TAVR procedures.
- read the Forbes piece
- here's The Gray Sheet link (sub. req.)
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