Medicare Approves Coverage for Abbott’s TriClip G5 Device for Tricuspid Valve Repair
On July 2, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination (NCD) that grants Medicare coverage for Abbott's TriClip G5 device. This device is FDA-approved for Transcatheter Edge-to-Edge Repair (T-TEER) to treat symptomatic tricuspid regurgitation (TR), a condition affecting approximately 1.6 million Americans with moderate to severe TR. The coverage is provided under Coverage with Evidence Development (CED), ensuring treatment access for eligible Medicare and Medicare Advantage beneficiaries who meet specific criteria.
The decision supports expanded access to this minimally invasive therapeutic option, particularly benefiting patients who are ineligible for open-heart surgery. TriClip G5 offers a potential path to improved quality of life and reduced hospitalizations for heart failure among this patient population. Abbott is concurrently launching the TriClip G5 alongside its MitraClip G5 system, both of which feature enhancements aimed at precision, ease of deployment, and improved procedural outcomes.
The CMS coverage is linked with an ongoing real-world evidence study titled TRIClip CoverAge with Evidence Development (TRICARE), sponsored by Abbott. This study fulfills part of the NCD's evidence-generation requirements under the CED framework, supporting continuous assessment of clinical outcomes and safety.
This coverage decision reflects broader trends in cardiac device innovations, paralleled by approvals and updates from other market players such as Medtronic and Foldax, which are advancing heart valve repair and replacement technologies. The NCD facilitates predictable reimbursement pathways, which may encourage wider adoption and integration of T-TEER in cardiac care protocols within the Medicare population.
Regulatory and compliance aspects underscore the importance of adhering to specified eligibility criteria and ongoing evidence submissions. The decision aligns with regulatory trends emphasizing minimally invasive interventions to improve patient outcomes and healthcare resource utilization in cardiovascular disease management. Stakeholders including providers, payers, and device manufacturers will be closely monitoring the implementation and impact of this coverage on treatment patterns and market dynamics.