Weekly vascular bulletin — September 7, 2026

Revised edition of the bulletin for the week of August 31 to September 7. A slow week for clinical evidence: ESC 2026 brought no peripheral vascular trials and CIRSE is still ongoing with no results yet. Regulatory and industry news dominate; 9 items, figures verified against the source.

Priority areas

1) Medicare approves NTAP for the Spur recoverable stent (infrapopliteal) [Regulatory/Industry]

Up to US$2,596.75 per case starting October 1, 2026, for a maximum of two years. Basis: DEEPER REVEAL (n=130, 49 centers, single-arm): primary patency 78%, freedom from revascularization 83.1%, healing 84.3% at 12 months. Why it matters: reimbursement, not new evidence; no comparator; manufacturer data.
https://vascularnews.com/cms-approves-new-technology-add-on-payment-for-reflow-medicals-spur-system/
https://vascularnews.com/reflow-medical-announces-12-month-results-from-deeper-reveal-trial/

2) Abbott: CE mark for the 76 mm Esprit BTK [Regulatory CE]

Line extension with no data of its own; the evidence remains LIFE-BTK with short lesions.
https://vascularnews.com/abbott-secures-ce-mark-for-longer-length-esprit-btk-system/

3) Shockwave becomes J&J MedTech as of October 1 [Industry]

Supplement on IVL in calcified CLTI: sponsored, with no new numerical data.
https://evtoday.com/news/shockwave-medical-to-rebrand-as-johnson-johnson-medtech

4) Clopidogrel metabolism variants and cardiovascular events after peripheral intervention (VAM 2026, Pittsburgh) [Congress]

~20% carriers; no increase in limb events, but more myocardial infarction and stroke at one year. Observational, no effect-size figures; does not support routine genotyping.
https://vascularspecialistonline.com/study-links-clopidogrel-genetic-variants-to-cardiovascular-risk-after-pad-intervention/

Aorta

5) Endurant: CE mark without ruptured-AAA warning (Medtronic, Sep 4) [Regulatory CE]

Aligns Europe with the FDA (Oct 2025); ENGAGE registry at 10 years; no new rupture figures.
https://vascularnews.com/medtronics-endurant-stent-graft-system-receives-ce-mark-for-updated-rupture-labelling/

6) EVAR XplantR (Hjarta Care): first instrument dedicated to endograft explantation; FDA De Novo Apr 29, 2026 [Technology]

Multicenter simulations: atraumatic extraction 100%, <90 s versus 20–40 min. Bench data, not clinical.
https://vascularnews.com/there-really-is-nothing-else-like-this/
https://evtoday.com/news/hjarta-cares-evar-xplantr-for-aortic-endograft-explantation-receives-fda-de-novo-authorization

Venous / PE

7) TRUST completes enrollment: Laguna in PE, n=107, 17 centers; results at VIVA October 5 [Clinical trial]

Single-arm, no data yet.
https://vascularnews.com/innova-vascular-announces-completion-of-enrollment-in-trust-trial-3/

Hemodialysis access

8) aXess at 12 months: primary patency 34%, assisted 49%, cumulative 79% (n=120) [Publication-commentary]

Figures similar to ePTFE; U.S. IDE still pending.
https://vascularnews.com/european-axess-data-a-step-forward-in-an-evolving-field/

Technology

9) CE mark for the Photonova Spectra photon-counting CT (GE) [Regulatory CE]

Less calcium and stent artifact; no peripheral vascular studies.
https://vascularnews.com/ge-healthcare-lands-ce-mark-for-advanced-photon-counting-ct-system/

Meetings

CIRSE Copenhagen through Sep 9; Eastern Vascular Society, Washington, Sep 17–19; Midwestern Vascular, Chicago, Sep 17–20; NY Endovascular Summit, Sep 24–26; PE Symposium, Boston, Sep 30–Oct 3; VIVA, Las Vegas, Oct 4–7 (TRUST on the 5th); ESVS, Belgrade, Oct 6–9.

Note: this edition replaces the one sent at 11:24; an opinion item was removed and the DEEPER REVEAL and XplantR figures were verified.

Kind regards.

Weekly vascular bulletin — September 7, 2026

A slow week for peripheral vascular clinical evidence, dominated by regulatory and industry news: 9 verified items covering Medicare reimbursement, CE marks and a new explantation device.

Three worth your time:
• Medicare approves NTAP reimbursement (up to $2,596.75/case) for the Spur recoverable stent, based on single-arm DEEPER REVEAL data with no comparator.
• EVAR XplantR receives FDA De Novo authorization as the first dedicated endograft explantation instrument, with bench data showing atraumatic extraction under 90 seconds.
• A VAM 2026 study links clopidogrel metabolism variants to more myocardial infarction and stroke after peripheral intervention, though it does not support routine genotyping.

Full bulletin: https://boletinesmedicos.com/en/vascular/2026-09-07.html

Weekly vascular bulletin, Sep 7: Medicare approves NTAP for the Spur recoverable stent (DEEPER REVEAL data, no comparator); EVAR XplantR gets FDA De Novo clearance; clopidogrel variants linked to more MI/stroke post-PAD intervention. Full bulletin: https://boletinesmedicos.com/en/vascular/2026-09-07.html