TAVI NEWS WEEKLY — 10 Sep 2026

1. What changed this week

[Other] Emboline Emboliner — US FDA 510(k) clearance 9 Sep 2026 for embolic protection during TAVR (cerebral + systemic; dual-layer filter with central working lumen). Supported by PROTECT H2H vs SENTINEL; phased US commercial launch later this year. Adjacent cath-lab noise, not a valve competitor.

Sources:

https://www.prnewswire.com/news-releases/emboline-receives-us-fda-510k-clearance-for-emboliner-embolic-protection-system-302873269.html

https://healthtechnologynet.com/2026/09/09/emboline-receives-u-s-fda-510k-clearance-for-emboliner-embolic-protection-system/

[Payer] CMS TAVR NCD (CAG-00430R2): Decision Memo still blank on tracking sheet (checked 10 Sep). Expected NCA completion 13 Sep 2026 (T-3). Proposal unchanged: 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 (not overnight new): TAVI-PCI (ESC 30 Aug; NEJM) — N=986; TAVI-first noninferior to PCI-first at 1 yr (22.2% vs 24.2%). ACASA-TAVI (ESC/JAMA) — NOAC vs ASA reduced HALT.

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/

Abbott / Edwards / MDT product or regulatory PR since 9 Sep post: nothing material. SMART 3-yr, VANTAGE, NAVULTRA, Meril AU already covered earlier this week — not re-run as new.

2. 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] Embolic protection is adjunctive — do not invent stroke-rate comparisons for Navitor; stick to approved design/claims language. (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/

[Abbott] NAVULTRA registry (Navitor vs S3 Ultra, small annuli): disclose hemodynamics/PPM vs mild PVL and PPI 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 or TAVI-PCI Sapien numbers for Navitor. Do not claim CMS outcomes until final memo. Do not use HERA-TAVI without fair balance on PPI.

3. Papers / abstracts to read

Emboliner PROTECT H2H / FDA 510(k) (9 Sep 2026)

HERA-TAVI — EuroIntervention 2026 (DOI 10.4244/eij-d-26-00390)

TAVI-PCI — NEJM (ESC 30 Aug 2026)

SMART 3-yr — Medtronic / EuroPCR 20 May 2026

VANTAGE 1-yr — PubMed 40892604

NAVULTRA — EuroIntervention 2026

TCT 2026 LBCTs: PROGRESS primary (Généreux); EARLY TAVR economics (Butala) — 31 Oct–3 Nov

CMS final decision memo — watch 13 Sep 2026

4. Ignore list

Rumor, stock tips, off-label / unapproved US low-risk claims, patient-level PHI, analyst market-share % without approved commercial source, X as primary evidence, reprinting prior-week items as overnight news.

Watch: CMS final memo ~13 Sep (3 days).