Abbott (NYSE:ABT) announced today that CMS revised its coverage for TMVR, opening up new possibilities for its MitraClip device.
The CMS National Coverage Determination (NCD) expands coverage for transcatheter mitral valve repair (TMVR) to include patients with secondary (or functional) mitral regurgitation (MR) resulting from heart failure.
According to an Abbott news release, the CMS decision significantly increases the number of people eligible for insurance coverage for mitral valve repair with MitraClip. Abbott said the revision is critically important to secondary MR patients as most impacted by MR are older, while several would be required to pay out of pocket for the procedure, creating a barrier of access.
“Secondary mitral regurgitation generally impacts older individuals suffering from heart failure who rely on Medicare for their healthcare coverage,” Abbott structural heart business chief medical officer Dr. Neil Moat said in the release. “CMS’ decision to expand coverage for MitraClip marks a pivotal moment for people seeking a minimally invasive option that reduces mitral regurgitation and significantly improves their quality of life and chances of survival.”
MitraClip is delivered to the heart through a vein in the leg and clips portions of the leaflets or flaps of the mitral valve together to reduce the backflow of blood. The system was awarded the 2020 Prix Galien USA Award for Best Medical Technology in November of last year.
The device secured its first FDA approval in 2013 and its most recent iteration, the MitraClip G4, garnered FDA approval in July 2019, followed by CE Mark approval in September 2020.
In January 2020, the FDA approved a clinical trial to study the effectiveness of MitraClip in people eligible for open-heart surgery, while analysis presented by Abbott in November 2020 revealed that the latest MitraClip performs as well as the previous version of the heart valve technology.
“Approximately four million Americans suffer from MR, and it’s estimated that two to three times as many patients may benefit from MitraClip for secondary mitral regurgitation than those for the primary form of the disease,” Abbott structural heart business enior VP Michael Dale said. “We’ve worked tirelessly, for nearly two decades, to make MitraClip’s leading technology available to patients suffering from mitral regurgitation, and CMS’ expanded coverage allows our safe, effective and potentially life-saving treatment option to be available to the many more people who could benefit from our minimally invasive therapy.”