The Centers for Medicare and Medicaid Services has agreed to cover transcatheter edge-to-edge repair for tricuspid valve regurgitation, including Abbott’s TriClip system.
In a LinkedIn post, Abbott called the national coverage determination a milestone for patients with severe tricuspid regurgitation that will support broader access to a minimally invasive treatment for those who are not good candidates for surgery.
“This decision helps open the door to treatment for more people living with symptomatic severe tricuspid regurgitation – many of whom have had few options in the past. It also provides additional clarity for care teams working to bring minimally invasive solutions to these complex patients,” Sandra Lesenfants, senior vice president of Abbott’s structural heart division, said on LinkedIn.
Abbott’s device is now included in the Medicare NCD, according to the post.
Abbott requested a national coverage analysis for the tricuspid valve repair procedure, also known as T-TEER, in March 2023, as the Food and Drug Administration conducted a parallel review of its TriClip device. TriClip received FDA approval in April 2024.
Tricuspid regurgitation is a condition where the valve between the two right heart chambers doesn’t close properly, allowing blood to leak backward. It can reduce the amount of blood pumped through the body, causing the heart to work harder, and can lead to shortness of breath, atrial fibrillation and heart failure if untreated.
Abbott’s TriClip device pulls together the leaflets of the tricuspid valve with a clip to help blood flow in the right direction and reduce leaking.
In data presented at the American College of Cardiology meeting earlier this year, patients with severe tricuspid regurgitation who received a TriClip device with medical therapy were 28% less likely to be hospitalized for recurrent heart failure at two years than those treated with drugs alone.
Abbott competitor Edwards Lifesciences makes a transcatheter tricuspid valve replacement device called Evoque to treat tricuspid regurgitation. Evoque won FDA approval in February 2024.
