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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
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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.
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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.
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“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.”
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Imaging Is the Gateway to TAVR — and the Bottleneck to Scale
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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.
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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:
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- Efficient TAVR planning. Fast, intuitive, and reproducible CT-based workflows for valve sizing and vascular access assessment reduce the time from referral to heart team decision, helping programs shorten waitlists as volumes grow.
- Standardized, heart-team-ready reporting. Customizable structured reports deliver exactly what the implanting physician needs, supporting the multidisciplinary heart team model.
- Comprehensive patient assessment. cvi42‘s multi-modality platform — spanning cardiac CT, cardiac MR, interventional planning, and electrophysiology planning — supports the deeper phenotyping heart teams need to select the right patients and plan the right intervention.
- Beyond the aortic valve. The same platform supports transcatheter mitral valve replacement (TMVR) planning and left atrial appendage occlusion (LAAC) planning, allowing programs to standardize one imaging environment across their entire structural heart service line — whichever of those scans a given patient needs.