The Centers for Medicare & Medicaid Services issued a final coverage decision for transcatheter mitral valve replacement devices, a decision that currently only affects Abbott’s (NYSE:ABT) MitraClip implant.
The new memo largely parallels the proposal made in May, granting "Coverage with Evidence Development," meaning the devices will be reimbursed but hospitals must agree to participate in a patient registry.
That’s great news for Abbott’s MitraClip device, which won FDA approval in October 2013 to treat mitral valve regurgitation in patients who are too sick or otherwise ineligible for open surgery.
Other devices in development include Mitralign’s annuloplasty device, MiCardia’s enCorSQ and TransCardiac Therapeutics’ MitraFlex technology.