TAVI NEWS WEEKLY — 5 Oct 2026
1. What changed this week
[Edwards] On 1 Oct the FDA approved the AUTUS Size-Adjustable Valve, a surgical pulmonary valve for pediatric congenital heart disease. It can be expanded later with a transcatheter balloon as the child grows, and it's the first US-approved heart valve with polymeric rather than tissue leaflets. It had Breakthrough designation, and the approval was based on a 62-patient pediatric study. It isn't a TAVI device, but it shows Edwards pushing a lifetime-management story across its structural heart portfolio. (FDA, Edwards newsroom, MassDevice, 1 Oct)
Source:
https://www.edwards.com/newsroom/news/2026-10-01-edwards-lifesciences-receives-fda-approval-for-aut
[Payer] Public comments on CMS's open aortic regurgitation reconsideration (CAG-00430R3) close on 10 Oct. The final TAVR NCD from 10 Sep stands, and implementation guidance is still pending. (CMS, ACC)
Source:
https://www.cms.gov/medicare/coverage/evidence/aortic-valve-replacement
[Edwards] The PROGRESS trial (moderate AS, TAVR vs surveillance, 2,250 patients) is confirmed for TCT Late-Breaking Session II on 2 Nov, presented by Généreux. (CRF/TCT)
Source:
[Abbott] [MDT] Neither company issued a new TAVI product press release since 1 Oct.
2. Competitor talking points I will hear in the cath lab
[Edwards] "Edwards owns lifetime management, from pediatric valves that grow to ViV and redo." Expect AUTUS to be mentioned alongside last month's China ViV approvals.
[Edwards] "Moderate AS is next." Expect PROGRESS hype to build before TCT. The data aren't out yet.
[MDT] SMART three-year small-annulus hemodynamics still lead Evolut messaging.
3. Navitor leverage points
[Abbott] Redo and coronary access are coming up more in planning conversations. Navitor is intra-annular, and Abbott positions it on future coronary access. Use only approved Abbott materials. Flag: the VANTAGE "100% coronary access when needed" figure comes from an OUS low/intermediate-risk study. US labeling is high/extreme risk only, so this needs approved-claims review before any US use.
[Abbott] For small-annulus conversations, stick to approved TVT-registry Navitor content. Flag: claims review.
4. Papers / congress abstracts to read
[Other] A systematic review and meta-analysis of TAV-in-TAV vs TAV-in-SAV redo (4 observational studies, 705 patients). It found no clear mortality difference, lower 30-day gradients with TAV-in-TAV, and a non-significant trend toward more pacemakers. The authors call it hypothesis-generating. (iMedSource, 3 Oct)
Source:
[Market] A TVT Registry analysis found that Comprehensive Stroke Center hospitals and trial sites report more post-TAVR strokes, which the authors read as ascertainment bias. Adjusting for it changed public rankings at 8 of 153 stroke-center hospitals. (MedXY summary, 3 Oct)
Source:
[Other] A SOLACI editorial on long-term PPM, PVL and pacemaker consequences after TAVI. (SOLACI, 2 Oct)
Source:
5. Ignore list
Healio "TAVR is the cornerstone" interview clips (29 Sep) are general commentary.
PROGRESS analyst and stock chatter before TCT.
Anything off-label or patient-level.
