TAVI News Daily — 7 Sep 2026

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TAVI News Daily — 7 Sep 2026

1. What changed this week

• [Payer] CMS TAVR NCD (CAG-00430R2): proposed 15 Jun 2026; comment closed 15 Jul; expected final ~13 Sep 2026. Proposal: symptomatic severe AS without CED; asymptomatic under CED; revised heart-team / volume criteria. Decision memo not posted yet. Sources: CMS tracking https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?NCAId=321 ; proposed memo https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?NCAId=321&proposed=Y ; SCAI https://www.scai.org/media-center/news-and-articles/proposed-tavr-ncd-released-key-changes-and-next-steps

• - [Other] Meril Myval Octacor — first Australia implant, 7 Sep 2026 (St Vincent’s Sydney cited); ARTG May 2026. Source: https://www.healthindustryhub.com.au/medical-technology-news-trends/new-heart-valve-technology-brings-fresh-competition-to-tavi-market/

• - Abbott / Edwards / MDT product news in last 7–14 days: nothing material. Still circulating: VANTAGE 1-yr (EuroPCR May), SMART 3-yr (May), EARLY TAVR extended F/U (NY Valves late Jun).

2. Competitor talking points (cath lab)

• [MDT] SMART 3-yr (small annuli ≤430 mm²): Evolut vs Sapien — BVD 16.3% vs 54.4%; ≥mod PPM 9.9% vs 33.2%; death/disabling stroke/HF rehosp similar. Source: https://news.medtronic.com/SMART-Trial-three-year-data-demonstrate-superior-benefits-with-Evolut-TAVR-TM-system

• - [Edwards] EARLY TAVR extended F/U: death/stroke/HF hosp 15.2% vs 24.2% surveillance (HR 0.58); full 5-yr still pending. PROGRESS (moderate AS) baselines only; outcomes teed for TCT 2026. Sources: https://www.tctmd.com/news/early-tavr-5-year-data-still-support-tavi-over-surveillance-asymptomatic ; https://ir.edwards.com/news/news-details/2026/Edwards-Structural-Heart-Leadership-Demonstrated-Through-Expanding-Body-of-Scientific-Evidence-at-New-York-Valves/default.aspx

• [Other] JenaValve Trilogy FDA for native AR (Mar 2026) — AR pathway noise, not AS head-to-head. Meril OUS intermediate-sizing narrative.

3. Navitor leverage points (on-label only)

• [Abbott] US indication remains high/extreme risk in sourced materials — do not imply low/intermediate US use. (Claims review)

• - [Abbott] VANTAGE (CE low/intermediate): PubMed N=434; tech success 97%; 0% mod+ PVL at 30d; among first 262 with 12-mo F/U: 2.3% all-cause death or fatal/disabling stroke; mean gradient 8.0 mmHg, EOA 1.8 cm² at 12 mo. Sources: https://pubmed.ncbi.nlm.nih.gov/40892604/ ; https://www.massdevice.com/abbott-europcr-2026-navitor-tavi-data/ . Secondary LinkedIn EuroPCR figures need primary match before field use. (Claims review)

• - [Abbott] NAVULTRA registry (Navitor vs S3 Ultra, ≤430 mm², propensity 524 pairs): 1-yr mortality similar; lower gradients / less PPM with Navitor; higher mild PVL and PPI — disclose trade-offs. Source: https://eurointervention.pcronline.com/article/intra-annular-self-expanding-or-balloon-expandable-tavi-in-small-annuli-the-navultra-registry (Claims review — registry)

• - Do not borrow SMART Evolut numbers for Navitor. Do not claim CMS outcomes until final memo.

4. Papers / abstracts to read

• VANTAGE 1-yr — PubMed 40892604; EuroPCR interview 20 May 2026

• - SMART 3-yr — Medtronic / EuroPCR 20 May 2026

• - EARLY TAVR extended F/U — NY Valves ~24 Jun 2026 (TCTMD)

• - PROGRESS design — Am Heart J Jul 2026, PMID 41895563

• - NAVULTRA — EuroIntervention 2026

• - CMS proposed NCD finalize watch ~13 Sep

5. Ignore list

Rumor, stock tips, off-label / unapproved US low-risk claims, patient-level PHI, analyst market-share % without approved commercial source, X chatter as primary evidence (thin this week).

Watch: CMS final memo ~13 Sep.

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