Weekly vascular bulletin — September 5, 2026

Slow week for hard evidence: between August 29 and September 5 I found no new randomized trials in peripheral, aortic, carotid or venous disease. ESC 2026 (Munich, Aug 28–31) brought no vascular Hot Lines, and CIRSE 2026 opens today in Copenhagen, so its data will fall in next week's bulletin. What there was, was mostly regulatory and industry news. Ten items, no filler, priority areas first.

Priority areas: PAD/CLTI, calcium, BTK

1) CMS approves New Technology Add-on Payment (NTAP) for the Spur recoverable stent (Reflow Medical) in the infrapopliteal segment [Regulatory / Industry]

Temporary scaffold for 2.5–4.5 mm arteries, adjunctive to angioplasty, removed without leaving an implant; FDA De Novo in May 2025. Incremental payment of up to US$2,596.75 per inpatient Medicare case starting October 1, 2026, for up to two years. No new clinical data.
Why it matters: an adoption signal for "leave nothing behind" in BTK, but without a randomized comparison against angioplasty or drug-coated balloon; it changes reimbursement, not evidence.
https://vascularnews.com/cms-approves-new-technology-add-on-payment-for-reflow-medicals-spur-system/

2) Abbott obtains CE mark for the 76 mm Esprit BTK in CLTI [CE Regulatory]

Longer version of the everolimus-eluting resorbable scaffold for the infrapopliteal segment. Abbott argues that most BTK lesions in CLTI exceed 100 mm. The FDA had already cleared it in early 2026.
Why it matters: the evidence base remains LIFE-BTK (short lesions); there are no published data for the 76 mm length or for long lesions.
https://vascularnews.com/abbott-secures-ce-mark-for-longer-length-esprit-btk-system/
https://evtoday.com/news/abbotts-76-mm-esprit-btk-system-for-clti-approved-in-europe

3) DASBAD-NC: randomized trial of a directional scoring balloon (DK Medtech) versus a non-compliant balloon in the femoropopliteal segment [Clinical trial – announcement]

Prospective, multicenter, 142 patients; PIs Marc Sirvent (Spain) and Marco Manzi (Italy); first patient expected Q4 2026.
Why it matters: announcement only; it builds on the prior DASBAD trial (less bailout stenting, better patency) with a small sample and manufacturer sponsorship. It does not change practice.
https://evtoday.com/news/dasbad-nc-trial-will-evaluate-dk-medtechs-NC-directional-scoring-balloon-in-clti

4) Clopidogrel metabolizer genotype and events after peripheral intervention (data from VAM 2026, covered this week) [Congress]

Pittsburgh group (Tzeng, Reitz): roughly 20% of patients undergoing PAD intervention carried the variants; no increase in limb events at one year, but more major cardiovascular events.
Why it matters: the coverage gives no sample size or effect magnitude, and the study is observational; the authors do not recommend changing antiplatelet therapy. Included for lack of fresh peripheral data, with that caveat.
https://vascularspecialistonline.com/study-links-clopidogrel-genetic-variants-to-cardiovascular-risk-after-pad-intervention/

5) Shockwave Medical begins operating as Johnson & Johnson MedTech starting October 1 [Industry]

The coronary and peripheral IVL line (including Javelin) and the Reducer will be renamed "circulatory restoration solutions." This week Vascular News published a supplement on IVL as first-line therapy in calcified CLTI.
Why it matters: the supplement is Shockwave-sponsored content with no new figures; the rebranding only matters for tracking the products going forward.
https://evtoday.com/news/shockwave-medical-to-rebrand-as-johnson-johnson-medtech
https://vascularnews.com/shockwave-ivl-the-first-line-strategy-for-calcified-clti-disease/

Rest of the specialty

6) Aorta: CE mark to remove the ruptured AAA warning from the Endurant (Medtronic) label [CE Regulatory]

Europe aligns with the FDA (Oct 2025); supported by the 10-year ENGAGE registry; the notice cites no rupture-specific data.
Why it matters: formalizes standard practice and facilitates protocols, with medicolegal implications; there is no new evidence in rAAA.
https://vascularnews.com/medtronics-endurant-stent-graft-system-receives-ce-mark-for-updated-rupture-labelling/

7) FDA early alert: Boston Scientific recalls Imager II angiographic catheters [FDA Regulatory]

Manufacturing defect with risk of tip detachment; two serious injuries, no deaths (as of July 16). Stop use, segregate by UPN, and return.
Why it matters: a high-volume diagnostic catheter; check local stock and notify interventional and radiology teams.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-angiographic-catheter-issue-boston-scientific

8) Venous/PE: pivotal TRUST trial of the Laguna thrombectomy system (Innova Vascular) completes enrollment [Clinical trial]

Single-arm IDE study, 107 patients with PE at 17 centers; aspiration (Malibu 12–24 F) plus mechanical extraction. Results at VIVA, October 5, 2026.
Why it matters: one more competitor without a randomized comparator; what matters will come at VIVA.
https://evtoday.com/news/trust-pivotal-study-of-innova-laguna-thrombectomy-system-completes-enrollment

9) Hemodialysis access: critical reading of European data on the aXess graft (Xeltis) [Publication – commentary]

Bart Dolmatch reviews the European pivotal study (single arm, 120 patients): at 12 months, primary patency 34%, assisted 49%, cumulative 79%; cannulatable from 14 days; fewer interventions and infections than reported for PTFE (meta-analysis of 3,381 grafts: 41/46/70%).
Why it matters: primary patency does not exceed PTFE and the comparison is historical; the interest lies in infection and remodeling. Author declares no conflicts.
https://vascularnews.com/european-axess-data-a-step-forward-in-an-evolving-field/

10) Prevention: STAREE, atorvastatin 40 mg in patients ≥70 years without cardiovascular disease (NEJM, ESC 2026) [Clinical trial]

9,971 Australian participants (52% women, mean age 74.7) without cardiovascular disease, diabetes or dementia; median follow-up 5.9 years. MACE 6.0% vs 8.3% (HR 0.70; 95% CI 0.61–0.82); no difference in disability-free survival (HR 0.94; CI 0.84–1.05). More muscular/hepatic effects and diabetes; serious adverse events 2.7% in both groups. Publicly funded.
Why it matters: not a vascular trial, but it informs the decision to start a statin in the "healthy" older patient with a borderline ABI or a small aneurysm; it excluded diabetics and established cardiovascular disease, so it does not apply to already-diagnosed PAD.
https://www.escardio.org/news/press/press-releases/cholesterol-lowering-medication-reduces-major-cardiovascular-events-by-30-per-cent-in-older-people-without-known-cardiovascular-disease/
https://www.nejm.org/doi/abs/10.1056/NEJMoa2607314

11) Technology: CE mark for the Photonova Spectra photon-counting CT (GE HealthCare) [CE Regulatory]

Deep-silicon detector, 0.23-second rotation, 80 mm coverage, spectral imaging; FDA 510(k) since March 2026.
Why it matters: promises CT angiography with less calcium and stent artifact, but with no published vascular clinical data and limited access due to cost.
https://vascularnews.com/ge-healthcare-lands-ce-mark-for-advanced-photon-counting-ct-system/

Upcoming meetings and dates

CIRSE 2026, Copenhagen, Sep 5–9 (underway). New York Endovascular Summit, Sep 24–26. PAIRS 2026, Dubai, Sep 29–Oct 2. The Veins at VIVA, Las Vegas, Oct 3–4, and VIVA 2026, Oct 4–7 (TRUST and, presumably, more peripheral IVL data). ESVS 40th Annual Meeting, Belgrade, Oct 6–9. VEITH will be in November.

Note: I could not directly access the JVS, EJVES or JVIR indices this week (restricted access); if anything relevant turns up in "articles in press," I will cover it in the next bulletin.

Best regards.

Weekly vascular bulletin — September 5, 2026

A slow week for hard evidence: no new randomized trials in peripheral, aortic, carotid or venous disease, but ten verified regulatory and industry items, priority areas first.

Three worth your time:
• CMS approves a New Technology Add-on Payment for the Spur recoverable stent (Reflow Medical) in BTK, starting October 1 — a reimbursement signal for "leave nothing behind," not new evidence.
• Abbott secures CE mark for a 76 mm Esprit BTK scaffold for longer CLTI lesions, with no published data yet at that length.
• Bart Dolmatch's critical read of European aXess (Xeltis) hemodialysis graft data: primary patency does not exceed PTFE, though infection and remodeling look favorable.

Full bulletin: https://boletinesmedicos.com/en/vascular/2026-09-05.html

Weekly vascular bulletin, Sep 5: no new randomized vascular trials this week, but CMS add-on payment for the Spur BTK stent, CE mark for 76 mm Esprit BTK, and a critical read of European aXess graft data. 11 verified items: https://boletinesmedicos.com/en/vascular/2026-09-05.html