Weekly vascular bulletin — September 14, 2026

WEEKLY VASCULAR BULLETIN — Week of September 7–14, 2026

Note for the week: it was a slow week in the priority areas. I found no new trials, major publications or regulatory approvals in calcium, atherectomy, intravascular lithotripsy or drug-coated balloons/stents in the femoropopliteal or infrapopliteal segments. Activity concentrated around CIRSE 2026 (Copenhagen, September 5–9), with news mainly in hemodialysis vascular access and pulmonary embolism. Sending 6 verified items rather than padding the issue.

Priority areas

1. CMS NTAP reimbursement for the infrapopliteal Spur retrievable stent (Reflow Medical)

[Regulatory / US reimbursement] — September 2 (12 days ago; included as the only item in the past two weeks in CLTI/infrapopliteal)
CMS granted a New Technology Add-on Payment (NTAP) for the Spur system, a retrievable stent with "spurs" for de novo or restenotic infrapopliteal lesions in 2.5–4.5 mm arteries, which provides temporary scaffolding and is removed without leaving an implant behind. The incremental payment is up to USD 2,596.75 per inpatient Medicare case, effective October 1, 2026 (fiscal year 2027), for up to 2 years. The device received FDA De Novo authorization in May 2025.
Why it matters: this is a reimbursement story, not an efficacy one; there is no randomized data against plain balloon angioplasty or drug-coated balloons, and the release comes from the manufacturer.
Source: https://evtoday.com/news/cms-ntap-granted-for-reflow-medical-spur-peripheral-retrievable-stent-system

2. SAVE trial at 2 years: Selution SLR sirolimus-eluting balloon (Cordis) in dysfunctional fistulas

[Clinical trial] [Congress: CIRSE 2026] — September 11
Randomized, multicenter, single-blind trial presented by Konstantinos Katsanos (Patras): Selution SLR versus high-pressure plain balloon angioplasty in AVF stenosis. Primary endpoint, functional primary lesion patency at 6 months: 78% vs 58.5% (p=0.026); the advantage was maintained at 2 years (p=0.023); hazard ratio for loss of patency with plain balloon 2.14 (95% CI 1.18–3.91; p=0.013). All-cause mortality at 2 years 7.1% vs 9.5%; no serious device-related adverse events.
Why it matters: the first randomized trial of sirolimus in AVF with a consistent result, but the coverage does not report the n, the study is industry-funded, and it is not yet published in a peer-reviewed journal.
Source: https://vascularnews.com/two-year-trial-results-support-sirolimus-eluting-balloon-for-patients-with-failing-avfs/

3. DEScover at 6 months: Solaris DE sirolimus-eluting covered stent in hemodialysis access

[Phase 2 clinical trial] [Congress: CIRSE 2026] [Industry] — September 8
Prospective multicenter feasibility study (NCT06096142), n=120: 80 AVF patients randomized 1:1 to Solaris DE vs plain balloon angioplasty and 40 with a graft in a single arm. Six-month primary lesion patency: 92.0% with Solaris DE vs 65.9% with plain balloon angioplasty in AVF; 93.5% in grafts. Circuit patency 81.3% vs 65.9% (AVF). 30-day safety: 97.3% event-free. ANVISA approved an additional cohort at an intermediate sirolimus dose.
Why it matters: a strong signal but still phase 2, with short follow-up, a graft arm with no comparator, and a company release; it still needs to be compared with covered stents already on the market.
Source: https://evtoday.com/news/solaris-de-covered-stent-for-dialysis-access-evaluated-in-6-month-descover-data

4. Penumbra launches Link, a clot-capture device for arterial thrombectomy

[Industry] — September 10–11
Link is deployed inside the organized arterial thrombus to engage and mobilize it while the Lightning Bolt catheter (computer-assisted vacuum thrombectomy, CAVT) extracts it; the company positions it for Rutherford 4 patients. The report includes only anecdotal experience from a single user (Thomas Heafner, SSM Health).
Why it matters: a commercial launch with no clinical data, no n and no technical success or distal embolization rates; independent series should be awaited before adoption.
Source: https://vascularnews.com/penumbra-launches-link-clot-capture-device-for-arterial-thrombectomy/

Rest of the specialty

5. Endurant (Medtronic) receives CE mark to remove the ruptured-AAA warning

[CE regulatory] — September 4
The European instructions for use for Endurant no longer carry the warning that it was not evaluated in ruptured abdominal aortic aneurysms. This follows the FDA (October 2025, the first EVAR endograft with that change) and the FDA's extension of the same change to Gore Excluder and Excluder Conformable in July 2026.
Why it matters: it formalizes a practice that was already widespread and may facilitate urgent EVAR, but the release does not cite registries or mortality figures and does not change the clinical indication.
Source: https://cardiovascularbusiness.com/topics/clinical/vascular-endovascular/medtronic-stent-graft-system-secures-key-labeling-update

6. STRIKE-PE: 1-year functional and quality-of-life subanalysis with Lightning Flash 16F

[Single-arm registry] [Congress: CIRSE 2026] — September 9
Of the first 1,000 patients with intermediate/high-risk PE (a 1,500-patient registry at 77 centers), 584 were treated with the 16F catheter and 208 have 1-year functional follow-up (John Moriarty, UCLA). RV/LV ratio 1.36 → 0.96 at 48 hours; major adverse events at 48 hours 1.5%; median thrombectomy time 25 minutes. Resting Borg score 5 → 0; 6MWT 347 → 384 m; EQ-5D-5L 0.455 → 0.802.
Why it matters: useful functional-recovery data, but with no anticoagulation-alone control arm and follow-up in only a fraction of the cohort, it does not allow the improvement to be attributed to the device.
Source: https://vascularnews.com/strike-pe-subanalysis-finds-durable-functional-and-quality-of-life-outcomes-for-cavt/

Dropped this week: a Penumbra "advertorial" in Vascular Specialist on acute ischemia (sponsored content); the FDA approval of Vesalio's pVasc NET (August 13, outside the window).

Upcoming meetings and dates

• Sept 17–19: Eastern Vascular Society, Washington DC
• Sept 30–Oct 3: 12th Annual Pulmonary Embolism Symposium (PERT), Boston
• Oct 3–4: The VEINS at VIVA, Las Vegas
• Oct 4–7: VIVA 2026, Las Vegas — 26 trials announced, including DISRUPT PAD BTK II (2 years), POWER PAD II (pulsatile IVL), SELUTION4SFA (12 months), PESTO-CFA, BOLT, C-TRACT (24 months), RAPID-PE
• Oct 6–9: ESVS 40th Annual Meeting, Belgrade (Sava Centar)

Sources verified on September 14, 2026. Critical reading and selection automated; always cross-check against the primary source.

Weekly vascular bulletin — September 14, 2026

A slow week in the priority areas: no new trials, publications or approvals in calcium, atherectomy, IVL or drug-coated devices in the femoropopliteal/infrapopliteal segments. Six verified items, mostly from CIRSE 2026.

Three worth your time:
• SAVE trial (2 years): Selution SLR sirolimus balloon beat plain balloon angioplasty for AVF stenosis, 78% vs 58.5% functional primary patency at 6 months, sustained at 2 years — but not yet peer-reviewed.
• DEScover (phase 2, 6 months): Solaris DE covered stent reached 92.0% primary lesion patency in AVF vs 65.9% with plain balloon angioplasty — early, industry-sponsored data.
• CMS granted NTAP reimbursement for Reflow Medical's Spur retrievable infrapopliteal stent, up to $2,596.75 per Medicare case — a reimbursement story, not an efficacy one.

Full bulletin: https://boletinesmedicos.com/en/vascular/2026-09-14.html

Weekly vascular bulletin, Sep 14: slow week, 6 verified items from CIRSE 2026. SAVE trial: sirolimus balloon beats plain balloon in AVF stenosis at 2 years (78% vs 58.5%, 6-month patency). DEScover: Solaris DE covered stent 92% patency in AVF. Full bulletin: https://boletinesmedicos.com/en/vascular/2026-09-14.html