Circle Cardiovascular Imaging Ready to Help Heart Teams Meet the Next Era of TAVR as CMS Finalizes Expanded Medicare Coverage

Article content

Every Scan. One Plan. One Platform.

Article content

With Medicare coverage now finalized for asymptomatic severe aortic stenosis, cvi42 gives TAVR programs the automated planning, standardized reporting, and single-platform efficiency needed to scale safely and sustainably

Article content

Article content

CALGARY, Alberta, Sept. 11, 2026 (GLOBE NEWSWIRE) — Circle Cardiovascular Imaging Inc. (Circle CVI), a global leader in AI-driven cardiovascular imaging software, today welcomed the final decision by the Centers for Medicare & Medicaid Services (CMS), announced September 10, 2026, to modernize its national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR). The finalized policy extends Medicare coverage to patients with asymptomatic severe aortic stenosis and eliminates coverage-with-evidence-development (CED) requirements for symptomatic patients — CED requirements remain in place for asymptomatic patients — while revising pre-procedural assessment, intraoperative, and procedural-volume criteria. CMS also clarified the heart team requirement at the center of the policy: every case review must include at least one cardiac surgeon and one interventional cardiologist experienced in aortic valve disease.

Article content

Article content

The decision follows the landmark EARLY TAVR trial, in which early intervention in asymptomatic severe aortic stenosis reduced the composite of death, stroke, or heart failure hospitalization to 15.2%, versus 24.2% with clinical surveillance — evidence that also supported the FDA’s expanded indication for TAVR in asymptomatic patients earlier this year. With an estimated hundreds of thousands of Americans living with unaddressed severe aortic stenosis, the finalized coverage policy is expected to significantly increase the number of patients referred for TAVR evaluation.

Article content

Article content

“CMS has opened the door for many more patients to be treated earlier, when outcomes are best. The question every structural heart program now faces is how to absorb that growth without compromising quality,” said Erkan Akyuz, Chief Executive Officer of Circle CVI. “Every TAVR journey begins with imaging. cvi42 was built to make that first step — and every step after it — faster, more consistent, and more scalable, so heart teams can turn expanded coverage into expanded access. That’s the idea behind cvi42 for structural heart: every scan, one plan, one platform. Whichever stage a patient is at — planning today, surveillance next year — the same platform reads it, so nothing gets lost switching tools.”

Article content

Article content

Imaging Is the Gateway to TAVR — and the Bottleneck to Scale

Article content

Every TAVR candidate requires a comprehensive pre-procedural CT workup: aortic annulus sizing, coronary height assessment, calcification evaluation, and iliofemoral access route analysis. As programs extend evaluation to asymptomatic patients — who are often younger and will live longer with their first valve — planning decisions around valve sizing, coronary access, and lifetime management become even more consequential. At the same time, CMS’s finalized requirements mean more hospitals can build TAVR programs, and existing programs will see referral volumes climb.

Article content

cvi42, Circle’s unified cardiovascular imaging platform trusted by more than 2,100 hospitals in over 90 countries, addresses this demand across the entire structural heart pathway:

Article content