BTIG analysts Marie Thibault and Sam Eiber say Abbott requested the NCA for its transcatheter edge-to-edge repair system for treating tricuspid valve regurgitation (T-TEER). It falls under a pilot through the Transitional Coverage of Emerging Therapy (TCET) pathway.
Abbott designed TriClip to treat tricuspid regurgitation (TR), or a leaky tricuspid valve. Delivered through a vein in the leg, the TriClip TEER technology clips together a portion of leaflets. It repairs the tricuspid valve and helps blood flow in the right direction without the need for open-heart surgery. The system received FDA approval in April.
TriClip could offer a new option for those who continue to have symptoms or persistent TR despite treatment with medical therapy. It now enters the U.S. TR treatment market that features the Edwards Evoque tricuspid valve. Evoque became the first transcatheter therapy approved to treat TR in February.
CMS’ NCA begins with a public comment period that remains open for the next 30 days. The analysts noted a due date of April 3, 2025, for a proposed decision memo. They expect a completed NCA by July 2, 2025. According to Thibault and Eiber, Abbott’s letter to CMS acknowledged national coverage determinations (NCDs) for mitral TEER coverage and transcatheter aortic valve replacement (TAVR), noting that CMS could consider a therapy-focused NCD organization that could include TEER for both mitral and tricuspid valves.
“We are pleased to see this announcement, which comes as expected after the FDA approved TriClip in April and since in recent commentary, management anticipated the NCD process starting soon,” the analysts concluded.
