TAVI News Daily — 9 Sep 2026

1. What changed this week

[Payer] CMS TAVR NCD (CAG-00430R2): Decision Memo still not released (checked 9 Sep). Expected NCA completion 13 Sep 2026. Proposal (15 Jun): symptomatic severe AS without CED; asymptomatic under CED; revised heart-team / volume criteria. Do not pre-claim final language.

Sources:

https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?NCAId=321
https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?NCAId=321&proposed=Y

[Other / Clinical] Still circulating this week (not new overnight): TAVI-PCI (ESC Hot Line 30 Aug; NEJM simultaneous) — N=986; TAVI-first noninferior to PCI-first at 1 yr (22.2% vs 24.2%; risk diff −2.0 pp; 95% CI −7.4 to 3.4; p for noninferiority <0.001). Edwards investigator grant noted in ESC disclosure.

Sources:

https://www.escardio.org/news/press/press-releases/a-tavi-first-strategy-was-noninferior-to-a-pci-first-strategy-in-patients-with-severe-aortic-stenosis-and-concomitant-coronary-artery-disease/

[Other / Clinical] ACASA-TAVI (ESC 2026; JAMA simultaneous): post-TAVI NOAC monotherapy vs ASA — reduced HALT; reported noninferior for bleeding / thromboembolic / death composite in ACC ESC coverage (N=360). Secondary circulating item only.

Source:

https://www.acc.org/latest-in-cardiology/articles/2026/08/29/08/48/sun-545am-combo-tavi-esc-2026

Abbott / Edwards / MDT product or regulatory PR since 8 Sep post: nothing material. Meril AU first implant (7 Sep), SMART 3-yr, EARLY TAVR extended F/U, VANTAGE 1-yr, NAVULTRA already covered earlier this week — not re-run as “new.”

2. Competitor talking points (cath lab)

[Edwards] TAVI-PCI gives RCT cover for individualized TAVI-first sequencing (Sapien-supported trial) — expect valve-first talk; platform-specific, not Navitor data.

[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

[Other] JenaValve Trilogy AR commercialization (Mar–Apr 2026) still account noise; not AS head-to-head.

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] Deferred-PCI / lifetime coronary-access conversation is louder after TAVI-PCI — use only approved Navitor design/claims language; do not co-opt Sapien trial results. (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, small annuli): disclose trade-offs (hemodynamics/PPM vs mild PVL and PPI).

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 or TAVI-PCI Sapien numbers for Navitor. Do not claim CMS outcomes until final memo.

4. Papers / abstracts to read

TAVI-PCI — NEJM (ESC 30 Aug 2026)

ACASA-TAVI — JAMA (ESC 2026) via ACC coverage

SMART 3-yr — Medtronic / EuroPCR 20 May 2026

VANTAGE 1-yr — PubMed 40892604

NAVULTRA — EuroIntervention 2026

CMS final decision memo — watch 13 Sep 2026

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), reprinting Meril AU / SMART / EARLY TAVR / VANTAGE as if they dropped overnight.

Watch: CMS final memo ~13 Sep (4 days).