The U.S. Centers for Medicare and Medicaid Services (CMS) issued a final national decision expanding Medicare coverage for transcatheter aortic valve replacement (TAVR) to include patients with severe aortic stenosis who have no symptoms, along with other changes to coverage conditions. The decision directly affects access to the procedure in the United States and could gradually increase the size of the TAVR market as the policy takes effect.
Aortic stenosis occurs when the valve responsible for regulating blood flow from the heart becomes narrowed, limiting blood flow to the body. Previous coverage primarily focused on patients with symptoms such as shortness of breath and chest pain. The new decision opens coverage to patients without these symptoms while retaining evidence-collection requirements for this group.
What changed in the coverage policy?
The decision ended a previous coverage-with-evidence-development requirement for TAVR procedures in patients with symptomatic severe aortic stenosis. In contrast, CMS retained evidence collection when treating asymptomatic patients, reflecting the continued need for additional clinical data on this group.
After the policy proposal was published in June, some U.S. medical associations had called for evidence-collection requirements to remain in place for all patients. Although medical groups generally supported expanding coverage to asymptomatic patients, some physicians believed the available data still needed to be strengthened.
Why does the decision matter to medical-device companies?
The decision followed the U.S. Food and Drug Administration's approval in April 2025 to expand the use of Edwards Lifesciences' Sapien 3 platform to include patients with severe aortic stenosis without symptoms. The expansion was based on the EARLY TAVR study, which reported that patients in this group achieved better outcomes after undergoing the procedure than those managed through clinical monitoring and watchful waiting.
Edwards welcomed the decision, saying the new criteria would help improve patients' access to treatment and create opportunities for TAVR programs. Medtronic, a competitor in the heart-valve field, also welcomed the decision, noting that it encourages continued evidence generation. According to Stifel analysts, TAVR accounts for approximately 75% of Edwards' revenue and about 5.5% of Medtronic's revenue, while they estimated the global market for the procedure at more than $7 billion.
Stifel and BTIG analysts described the decision as positive for the TAVR market, with Edwards expected to benefit particularly because of its leadership in the field. Edwards said implementing the policy would take time, so it maintained its previously announced financial guidance for 2026 and plans to provide longer-term guidance at an investor conference in December.
certi.news analysis
The actual change is not the approval of a new device, but an expansion of who can receive Medicare coverage for an existing procedure, moving asymptomatic patients from limited coverage into a coverage pathway conditional on evidence collection. This means the clinical and commercial impact of the decision will depend on the speed of implementation and medical programs' ability to accommodate new cases, not merely on the issuance of the decision.
One open question remains the amount of evidence that will accumulate regarding treatment of asymptomatic patients, since CMS has not eliminated evidence-collection requirements for this group. The agency also announced that it will review TAVR coverage for treating aortic regurgitation, a condition in which the valve does not close properly and blood leaks backward. CMS expects to issue a proposed coverage decision by March 2027, following the FDA's approval in March of the first TAVR system for this condition, JenaValve's Trilogy system.