TAVI NEWS WEEKLY — 21 Sep 2026

1. What changed this week

[Payer] CMS final TAVR NCD (CAG-00430R2), posted 10 Sep 2026: symptomatic severe AS covered without CED; asymptomatic severe AS under CED; revised Heart Team / operator / hospital criteria (eased, not removed).

Sources:

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

https://www.medtechdive.com/news/cms-expands-tavr-medicare-coverage-to-asymptomatic-patients/830186/

[Market] ACC / STS / SCAI joint statement (11 Sep 2026): welcome access expansion; stress Heart Team, registry participation, outcomes monitoring.

Source:

https://www.acc.org/latest-in-cardiology/articles/2026/09/11/18/54/acc-sts-and-scai-issue-joint-statement-on-tavr-national-coverage-determination

[Payer] [Other] CMS opened NCA CAG-00430R3 for TAVR in aortic regurgitation (10 Sep 2026); public comments through 10 Oct 2026; proposed memo due 10 Mar 2027; expected completion 8 Jun 2027; tied to JenaValve Trilogy FDA AR PMA (Mar 2026).

Source:

https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=324

[Edwards] Company statement same day as NCD: supports access / Heart Team; notes implementation will take time; reiterates 2026 guidance confidence.

Source:

https://www.businesswire.com/news/home/20260910286048/en/

Abbott / Edwards / MDT product PR this week window: nothing material new overnight (15–17 Sep scans).

2. Competitor talking points (cath lab)

[Edwards] Asymptomatic is now a Medicare pathway (CED) on the back of EARLY TAVR / Sapien FDA expansion — volume upside is ours.”

[MDT] In small annuli, SMART 3-year still shows Evolut hemodynamic / BVD edge vs Sapien; clinical composite similar.” (EuroPCR May 2026 data — not new overnight.)

[Other] “Pure AR is JenaValve’s game until CMS finishes CAG-00430R3 — don’t off-label AS valves for AR.”

3. Navitor leverage points (on-label only)

[Abbott] Stay on US label: symptomatic severe AS, high / extreme surgical risk. Do not claim asymptomatic Medicare CED coverage for Navitor without local MAC / approved claims review.

[Abbott] Intra-annular self-expanding design / coronary-access narrative and VANTAGE / TVT small-annulus data remain useful flag for approved claims review before quoting any specific rates in account conversations.

[Payer] For symptomatic AS accounts: NCD dropping CED may ease pathway friction for labeled devices meeting FDA indication + site criteria confirm local implementation before promising coverage.

4. Papers / abstracts to read

[Market] POPular ACE TAVI (ESC 2026 Hot Line; PCR Online coverage 14 Sep 2026): routine vs selective protamine after TF TAVI — routine cut death / clinically relevant bleeding composite; more anaphylaxis, no clear thrombosis rise.

Source:

https://www.pcronline.com/News/Congress-coverages/ESC/2026/POPular-ACE-TAVI-routine-or-selective-protamine-administration-after-TAVI

[Edwards] ReTAVI registry (EuroIntervention): redo-TAVI with Sapien 3 platform — procedural success / 30-day outcomes across failed THV types.

Source:

https://doi.org/10.4244/eij-d-25-01268

[Market] TAVI-PCI (ESC 2026 / NEJM): TAVI-first noninferior to PCI-first when both indicated (presented earlier this month; still useful for Heart Team sequencing talks).

5. Ignore list

Rumor / stock tips on NCD volume winners”; off-label AR promotion with AS valves; patient-level PHI; unverified X threads without primary CMS / society / journal links.