TAVI NEWS WEEKLY — 15 Oct 2026

1. What changed this week

[Other] FDA posted (9 Oct) a Class 2 recall of JenaValve Trilogy delivery catheters in 23, 25 and 27 mm (recall Z-0134-2027, firm-initiated 31 Jul). Reason: possible sleeve-liner separation that can make valve deployment difficult or impossible. Affected lots are quarantined and returned for replacement; listed distribution includes Great Britain, Germany, Denmark and Italy. Cardiovascular Business covered it 13 Oct. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222212

[Abbott] Abbott's TCT 2026 page (San Diego, 31 Oct–3 Nov) lists the BE TAVI early feasibility study of a novel Abbott balloon-expandable valve (Kodali, Sun 1 Nov, investigational device), Navitor IDE five-year outcomes (Kemp, Mon 2 Nov), one-year TVT registry real-world intra-annular self-expanding data (Makani, Tue 3 Nov), and a symposium on coronary access, durability and future reinterventions (Sun 1 Nov). https://www.structuralheart.abbott/conferences/tct-2026-navitor-tavi

[Other] BALANCE (NCT07794306), a UKE Hamburg investigator-initiated RCT: Meril Octapro+ balloon-expandable versus Navitor/Navitor Vision in annulus ≤430 mm², 510 patients randomised 2:1 to Octapro+, estimated start 26 Oct 2026, not yet recruiting. https://clinicaltrials.gov/study/NCT07794306

[Edwards] [Market] Edwards reports Q3 2026 on Wed 4 Nov after market close (call 5 pm ET). https://ir.edwards.com/events-presentations/event-details/2026/Q3-2026-Edwards-Lifesciences-Earnings-Conference-Call/default.aspx

[Payer] Medscape (13 Oct): cardiologists broadly welcome the September NCD but warn of self-referral risk now that a single interventional cardiologist or surgeon can evaluate and perform TAVR. ACC notes CMS implementation guidance is still pending. https://www.medscape.com/viewarticle/medicare-tavr-rule-changes-welcomed-cautious-eye-toward-self-2026a100129w

2. Competitor talking points I will hear in the cath lab

[Other] Meril may describe BALANCE as a head-to-head win-in-waiting versus Navitor in small annuli. It has not enrolled; there are no data.

[Edwards] Expect Edwards to push AS referral-pathway programmes off DETECT AS II (Edwards-sponsored, see section 4).

[Other] The JenaValve recall may come up in AR discussions. Trilogy is an AR device, not an AS competitor to Navitor; keep to facts and don't use it as a selling point.

[MDT] CCC live case 13 Oct: 23 mm Evolut FX+ valve-in-valve in a 23 mm Mosaic with balloon valve fracture. Small-surgical-valve ViV stays in MDT messaging alongside SMART.

3. Navitor leverage points (on-label only)

[Abbott] TCT brings fresh Navitor data (IDE five-year, TVT one-year). Use no figures until presented and released in approved Abbott materials. Flag: claims review.

[Abbott] BE TAVI is investigational: don't raise it proactively with customers; follow Abbott guidance. Flag: claims review.

[Abbott] The coronary access and reintervention symposium supports the intra-annular design story; approved materials only. Flag: claims review.

[Abbott] If asked about BALANCE, give trial design facts only. Flag: claims review.

4. Papers / congress abstracts to read

[Edwards] Elmariah et al., DETECT AS II, JAMA Cardiology, 14 Oct (Edwards-sponsored). Versus prior-year usual care at UCSF, an automated EHR opt-out referral raised 30-day valve specialist review from 15.8% to 39.3% and 90-day AVR from 15.0% to 25.6%. https://jamanetwork.com/journals/jamacardiology/fullarticle/10.1001/jamacardio.2026.4394

[Other] Broeze et al., PRO-TAVI SYNTAX sub-analysis, JACC: Cardiovascular Interventions (Cardiovascular Business, 14 Oct). The one-year primary composite didn't differ across SYNTAX groups and deferred PCI had less bleeding, but in the highest SYNTAX group death/MI/stroke was 30.9% with deferred PCI versus 14.8% with PCI first. Hypothesis-generating. https://cardiovascularbusiness.com/topics/clinical/structural-heart-disease/tavr/pci-tavr-may-still-be-safest-strategy-some-heart-patients

5. Ignore list

[Market] Simply Wall St (14 Oct) AUTUS "game changer" piece: stock commentary.

[Other] myneuronews (14 Oct) write-up of an unnamed short-frame self-expanding AR device: AI-style summary, unverifiable numbers.

[Other] Single-case hospital TAVR posts on X: patient-level, ignore.

[Other] Venus-PowerX PREVAILS enrolment: July news resurfacing, not new.