TAVI NEWS WEEKLY — 28 Sep 2026

1. What changed this week

[Edwards] 23 Sep 2026 — China's NMPA approved three new Sapien 3 valve-in-valve indications for symptomatic patients at high surgical risk or unsuitable for surgery (heart-team assessed): TAVR-in-SAVR (failed surgical aortic bioprosthesis), redo-TAVR (failed transcatheter aortic bioprosthesis), and mitral ViV (failed surgical mitral bioprosthesis). Edwards positions Sapien 3 as first/only THV in China with all three ViV pathways.

https://www.prnasia.com/story/549204-1.shtml

[Payer] CMS final TAVR NCD CAG-00430R2 (10 Sep) still the US coverage frame: symptomatic severe AS without CED; asymptomatic under CED. Parallel NCA CAG-00430R3 (TAVR for AR) remains open for public comment through 10 Oct 2026.

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

[Abbott] / [MDT] No new TAVI product PRs in the 22–28 Sep window.

2. Navitor leverage points (on-label only)

Stay on approved Navitor indication / geography. Do not claim China ViV parity or asymptomatic CED equivalence without approved claims review.

[Abbott] VANTAGE / ENVISION remain the lower-risk evidence tracks. Flag any comparative China-ViV or redo-TAVR claims for medical/legal review before use.

3. Papers / congress abstracts to read

Edwards China NMPA ViV PR (23 Sep) — primary source:

https://www.prnasia.com/story/549204-1.shtml

CMS CAG-00430R2 decision memo (10 Sep) and CAG-00430R3 AR tracking sheet (comments through 10 Oct).

Worthley et al., VANTAGE; Herrmann, SMART 3-year (EuroPCR 2026).

4. Ignore list

Rumor, stock tips, off-label promotion, patient-level PHI. IndexBox-style market-share forecasts without primary sources.

https://www.prnasia.com/story/549204-1.shtml

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