The Centers for Medicare and Medicaid Services (CMS) has granted national coverage for transcatheter edge-to-edge repair (T-TEER) of the tricuspid valve, including Abbott’s TriClip system. The approval expands access to a minimally invasive option for patients with severe tricuspid regurgitation—a condition in which a faulty valve causes blood to leak backward into the heart, potentially leading to heart failure.
Abbott, whose TriClip device received FDA approval in April 2024, welcomed the CMS decision as a “milestone” that will help reach patients not eligible for open-heart surgery. TriClip works by clipping together the valve’s leaflets to improve closure and reduce leakage.
In a major clinical trial, adding TriClip to medical therapy reduced hospitalizations for heart failure by 28% over two years. The CMS ruling brings clarity and broader adoption of T-TEER in clinical practice.
Edwards Lifesciences also entered the space with its Evoque device, approved earlier in 2024.
14-07-2025