Weekly vascular bulletin — October 12, 2026

Colleagues: this issue covers October 5 to 12, 2026. It was the week of VIVA 2026 (Las Vegas, October 4 to 7), so nearly all of the arterial content comes from its late-breaking sessions: these are meeting presentations, mostly without peer-reviewed publication and released by the manufacturers themselves, and they should be read as such. On the venous side, the week belonged to pulmonary embolism and two regulatory decisions; this issue includes no new trials of saphenous reflux, varicose veins, or venous ulcers. Fourteen verified items.

Peripheral arterial disease, calcium, and plaque modification

1. Sirolimus-coated balloons in the femoropopliteal segment: three studies at VIVA

[Clinical trial] [Meeting] [USA / Switzerland / Germany]
SELUTION4SFA randomized 300 patients with symptomatic peripheral artery disease to the Selution SLR sirolimus-coated balloon or an uncoated balloon: the primary efficacy endpoint at 1 year was 78.6% versus 65.2% (P = 0.019), with primary patency of 90.3% versus 79.4% (P = 0.006). A secondary analysis of SirPAD in 421 patients without tissue loss (MagicTouch balloon versus uncoated balloon), published in JACC according to TCTMD, showed 1-year target lesion revascularization of 17.0% versus 27.1% and major adverse limb events of 4.1% versus 8.9%. The SUCCESS PTA postmarket registry (720 patients, no comparator) reported 24-month freedom from target lesion revascularization of 86.1% (83.0% in chronic limb-threatening ischemia).
Why it matters: sirolimus adds a positive randomized trial in the superficial femoral artery and clinical outcome data a few months after the focused update of the ESVS guideline (June 2026) called for caution with paclitaxel-coated devices in claudication; but the comparator is still plain balloon angioplasty rather than a paclitaxel-coated balloon, follow-up is 1 year, and the studies depend on the manufacturers (Concept Medical funded SirPAD; Selution is a Cordis device).
https://www.tctmd.com/news/sirolimus-dcbs-pad-and-clti-three-studies-add-support

2. Bioresorbable scaffolds below the knee: Esprit in real-world practice and MOTIV by Rutherford class

[Clinical trial] [Meeting] [USA]
The Esprit BTK postapproval study (Abbott; 200 patients, 50 sites, no comparator) reported at 6 months a 5.5% rate for the primary safety endpoint (major adverse limb event or perioperative death), freedom from clinically driven target lesion revascularization of 93.8%, amputation-free survival of 88%, and 7 major amputations. In the randomized MOTIV trial (Reva Medical; 292 patients versus plain balloon angioplasty; 90 in Rutherford class 4 and 202 in Rutherford class 5), the overall primary endpoint at 12 months was 70% versus 48% (P = 0.0003); by subgroup, the composite of limb salvage and primary patency at 12 months was 76.7% versus 54.5% in Rutherford 4 and 65.7% versus 46.2% in Rutherford 5.
Why it matters: the benefit of scaffolding appears to hold in patients with tissue loss, who need it most; but this is a subgroup analysis without P values, released by the manufacturer, Motiv remains investigational, and the Esprit study has no control arm (the TCTMD report also contains two revascularization figures, 93.8% freedom and a 7.7% rate, that do not reconcile: the publication is needed).
https://www.tctmd.com/news/esprit-and-motiv-bioresorbable-scaffolds-hit-their-stride-btk-procedures
https://evtoday.com/news/subgroup-analysis-presented-from-revas-motiv-btk-pivotal-trial

3. DISRUPT PAD BTK II: infrapopliteal intravascular lithotripsy at two years

[Clinical trial] [Meeting] [USA]
Prospective, multicenter, single-arm postmarket study: 250 patients enrolled, 243 treated with Shockwave intravascular lithotripsy for calcified below-the-knee lesions (200 in Rutherford class 4 or 5). At 24 months: freedom from clinically driven target lesion revascularization 81%, freedom from major amputation 94.8%, major adverse limb events 29.1% (58 of 199), and all-cause mortality 23.8% (46 of 193); 76.6% were in Rutherford class 0 or 1, and quality of life (VascuQoL) improved by 5.8 points (P < 0.001).
Why it matters: it provides two-year follow-up of calcium modification below the knee in a population made up mostly of patients with chronic limb-threatening ischemia (200 of 250 in Rutherford class 4 or 5), but there is no comparator, the sponsor is the manufacturer (Johnson & Johnson MedTech), and attrition is high (46 deaths, 30 withdrawals, and 14 lost to follow-up), so the late percentages call for caution.
https://viva-foundation.org/news-article?id=220781
https://evtoday.com/news/jjs-shockwave-peripheral-ivl-evaluated-at-24-months-in-disrupt-btk-ii-postmarket-study

4. POWER PAD II: a second intravascular lithotripsy system in calcified femoropopliteal disease

[Clinical trial] [Meeting] [USA]
Prospective, multicenter, single-arm IDE study of the Pulse IVL system in 115 patients at 17 US sites with calcified femoral and popliteal arteries. Final residual stenosis below 50% in 98.3%; freedom from major adverse events at 30 days 98.3%; patency of 94% at 30 days and 91% at 6 months; no clinically driven target lesion revascularization; ankle-brachial index from 0.76 to 0.99.
Why it matters: if confirmed, there would be real competition in peripheral lithotripsy, which could affect pricing; but this is six months of follow-up, with no comparator and no head-to-head comparison with Shockwave, in a study designed by the manufacturer (Amplitude Vascular Systems) to support its regulatory submission.
https://viva-foundation.org/news-article?id=220781

5. PROMISE III: transcatheter arterialization of the deep veins at one year

[Clinical trial] [Meeting] [USA]
Prospective, multicenter, single-arm study of the LimFlow system in 100 patients (103 limbs) with chronic limb-threatening ischemia and no conventional revascularization option; 74.8% in Rutherford class 5 and 25.2% in Rutherford class 6, 80% with diabetes and 13% on dialysis. At 1 year: limb salvage 84.1%, survival 91.4%, amputation-free survival 76.3%, and wounds healed or healing in 91.5%; median pain went from 6 to 0.
Why it matters: it adds another prospective cohort in which most "no-option" patients keep their limb at one year after venous arterialization; but there is still no control group, the "healed or healing" category is soft, and the definition of "no-option" depends on each center.
https://viva-foundation.org/news-article?id=220781

6. AGILITY: the Revello self-expanding covered stent in iliac arteries at nine months

[Clinical trial] [Meeting] [USA / Europe / Australia and New Zealand]
Iliac cohort of BD's IDE study: 120 patients at 28 sites, moderate or severe calcification in 49.6% according to the abstract presented at VIVA, 40.8% women. The primary composite safety and effectiveness endpoint at 9 months was 2.8% (3 of 108; 95% CI, 0.6% to 7.9%) against a performance goal of 19% (P < 0.0001); primary patency 97.2% and freedom from clinically driven target lesion revascularization 98.3%, with no major amputations. The device has held the CE mark since March 2026 for the common and external iliac arteries and remains investigational in the United States.
Why it matters: good numbers, but against a performance goal rather than the balloon-expandable covered stents that currently dominate the calcified iliac segment; nine months is short for a covered stent, and the study belongs to the manufacturer.
https://viva-foundation.org/news-article?id=220783
https://evtoday.com/news/agility-9-month-data-presented-for-bds-revello-vascular-covered-stent

7. The saphenous vein wall also decides the graft: a Japanese series of 89 limbs

[Publication] [Japan]
On October 7, Annals of Vascular Diseases published a study of 89 limbs undergoing bypass with the great saphenous vein: primary patency was 72.3% at 1 year and 59.3% at 2 years, and greater medial thickness of the vein before implantation, associated with more severe wound grade, was linked to loss of patency. In parallel, on October 6 Vascular Specialist reported a single-center series from Boston (223 patients with chronic limb-threatening ischemia, Journal of Vascular Surgery) supporting routine vein mapping before revascularization, with no figures in the report.
Why it matters: a reminder that diameter is not the only measure of conduit quality and that the sickest limb tends to carry the worst vein; this is a small observational series, not replicated outside Japan, and medial thickness is not routinely measured today. (Primary source in English, Japanese journal.)
https://www.jstage.jst.go.jp/article/avd/19/1/19_oa.26-00166/_article/-char/en
https://vascularspecialistonline.com/study-supports-routine-vein-mapping-before-clti-revascularization/

Venous disease and thromboembolism

8. TRUST: the Laguna thrombectomy system meets its goals in pulmonary embolism

[Clinical trial] [Meeting] [USA]
Prospective, single-arm pivotal IDE study in 107 patients with acute intermediate-risk pulmonary embolism (17 sites). The right-to-left ventricular ratio fell from 1.66 to 1.12 at 48 hours (mean reduction 0.53; 95% CI, 0.447 to 0.622) against a goal of 0.12, and there was a single major adverse event (0.9%), a bleed not attributed to the device; thrombectomy took 38 minutes on average and no thrombolytic was used. The system is FDA-cleared for the peripheral vasculature, not yet for pulmonary embolism.
Why it matters: another device that beats performance goals on a 48-hour surrogate endpoint; there is no comparison with anticoagulation alone or with other catheters, the study belongs to the manufacturer (Innova Vascular), and the data are unpublished.
https://vascularnews.com/innova-vasculars-laguna-thrombectomy-system-meets-primary-endpoints-in-pivotal-pulmonary-embolism-study/
https://viva-foundation.org/news-article?id=220779

9. HI-PEITHO: who bleeds with ultrasound-facilitated catheter-directed thrombolysis

[Clinical trial] [Meeting] [USA / Europe]
Post hoc analysis of the randomized HI-PEITHO trial (EKOS system plus anticoagulation versus anticoagulation alone in intermediate-risk pulmonary embolism). Major bleeding at 30 days was 4.0% versus 3.0% (P = 0.64), with no intracranial hemorrhage in either group. In multivariable analysis, cancer, right-to-left ventricular ratio, baseline NEWS score, and sex were associated with bleeding; cancer and a ratio of 1.5 or higher were associated with more bleeding on anticoagulation alone.
Why it matters: in a randomized trial, low-dose catheter thrombolysis showed no significant difference in major bleeding versus anticoagulation alone, and bleeding is the concern that most limits its use; but the predictors are exploratory, based on few events, and should not yet be used to select patients.
https://viva-foundation.org/news-article?id=220779

10. STORM-PE: smartwatches to measure functional recovery after pulmonary embolism

[Clinical trial] [Meeting]
In STORM-PE (100 patients randomized to computer-assisted vacuum thrombectomy or anticoagulation alone), a smartwatch substudy (65 patients enrolled in the wearable cohort) showed, in the 33 with the best compliance, a moderate correlation between daily steps on days 8 to 28 and the 6-minute walk test at 30 days (r = 0.44; P = 0.010; r = 0.57 and P < 0.001 for walking bout length), which weakens at 90 days.
Why it matters: wearables may become an objective functional endpoint in pulmonary embolism, but this is 33 patients and a correlation, not a treatment effect.
https://viva-foundation.org/news-article?id=220779

11. FDA expands the indication of the LOBO occluder to peripheral venous embolization

[Regulatory FDA] [USA]
Okami Medical announced on October 7 that the FDA expanded the indication of its LOBO vascular occlusion system to the peripheral veins; the company cites pelvic venous disease and portal hypertension as uses. The release does not specify the regulatory pathway or the exact wording of the indication, and it provides no new clinical data, only statements from two operators.
Why it matters: it adds a braided-mesh occluder, an alternative to coils and plugs, with a formal venous indication, useful in gonadal and pelvic reflux; but the decision is not supported by any reported venous study, and comparative evidence in pelvic venous disease remains scarce for any device.
https://www.prnewswire.com/news-releases/okami-medical-receives-expanded-indication-for-the-lobo-vascular-occluder-302901698.html
https://evtoday.com/news/okami-medical-receives-expanded-indication-for-lobo-vascular-occluder

Rest of the specialty

12. Brazil: ANVISA authorizes the Impede embolization plug family

[Regulatory ANVISA] [Brazil]
Shape Memory Medical reported on October 6 that the Brazilian agency ANVISA authorized the Impede, Impede-FX, and Impede-FX RapidFill plugs, made of porous shape memory polymer, to obstruct or reduce blood flow in the peripheral vasculature; the registration holder in Brazil is the company Biomedical. The release presents no new clinical results; it refers in general terms to published studies and to more than 3,500 patients treated worldwide.
Why it matters: it opens the Brazilian market to a radiolucent material; its most debated use, aneurysm sac filling during endovascular repair, depends on a randomized trial (AAA-SHAPE) that completed enrollment in July, has not yet reported results, and is not part of this authorization.
https://www.shapemem.com/shape-memory-medical-receives-anvisa-market-authorization-for-impede-embolization-plug-family-in-brazil/
https://vascularnews.com/shape-memory-medical-receives-anvisa-market-authorisation-for-impede-embolisation-plug-family-in-brazil/

13. PERFORMANCE II: one-year stroke with the Neuroguard carotid stent with integrated protection

[Clinical trial] [Meeting] [USA]
Subgroup analysis of the pivotal study of 305 patients at high surgical risk treated with a carotid stent with an integrated filter: 4 strokes at 30 days, all minor, and one more, also minor, through 1 year; no contralateral strokes. In the subgroups (symptomatic versus asymptomatic, over versus under 75 years) there were no differences; site-reported calcification showed a trend toward worse outcomes that the core laboratory did not confirm, and the authors acknowledge limited statistical power because of the low number of events.
Why it matters: stroke rates are low for carotid stenting in high-risk patients, but this is a single arm with no comparison with endarterectomy or transcarotid revascularization, and with five events no subgroup analysis can conclude anything.
https://viva-foundation.org/news-article?id=220783

14. Industry: B. Braun closes its US interventional division; Endologix becomes Rhevera

[Industry] [USA]
B. Braun announced on October 9 the closure of B. Braun Interventional Systems, whose interventional radiology and pediatric and congenital interventional cardiology portfolio includes angioplasty and valvuloplasty devices and vena cava filters; it will continue sales through March 31, 2027, and states there will be no immediate disruption to supply. Separately, Endologix (Alto and AFX2 stent grafts, the Detour percutaneous bypass system, Pounce thrombectomy) announced on October 6 its name change to Rhevera Medical.
Why it matters: there are no clinical data, but there is a practical consequence: anyone using vena cava filters or other products from that division should confirm continuity with their distributor beyond March 2027; the Endologix name change does not alter the devices.
https://evtoday.com/news/b-braun-medical-to-close-interventional-systems-division-1
https://venousnews.com/endologix-rebrands-as-rhevera-medical/

Coverage by region

Outside North America and Western Europe, this issue includes two items: Japan (item 7) and Brazil (item 12). The ESVS annual meeting (Belgrade, October 6 to 9) fell within the period; this issue does not include presentations from that meeting.

Upcoming meetings and dates

• SITE 2026: October 14 to 16, Santiago de Compostela.
• DFCon (diabetic foot): October 22 to 24, Anaheim.
• AMP Europe: October 26 to 28, Amsterdam.
• TCT 2026: October 31 to November 3, San Diego.
• SILAN: November 4 to 7, Guadalajara.
• Further ahead: Venous Symposium Europe (November 12 to 14, Athens) and VEITHsymposium (November 17 to 21, New York), which named Gustavo Oderich executive director and future chairman.

Weekly vascular bulletin — October 12, 2026
Week of VIVA 2026. The highlights:
• Sirolimus-coated balloons: SELUTION4SFA (300 patients) reached 78.6% versus 65.2% 1-year efficacy against plain balloon angioplasty.
• Lithotripsy below the knee at two years (DISRUPT PAD BTK II): 94.8% free from major amputation, no control group.
• Pulmonary embolism: the Laguna system meets its goals in 107 patients; in HI-PEITHO, no significant difference in major bleeding with catheter-directed thrombolysis (4.0% versus 3.0%; P = 0.64).
• FDA expands the LOBO occluder to venous embolization; ANVISA authorizes the Impede plugs in Brazil.
Full bulletin and audio: https://boletinesmedicos.com/en/vascular/2026-10-12.html

Weekly vascular bulletin — October 12, 2026

14 verified items from the week of VIVA 2026: late-breaking sessions, TCTMD, Endovascular Today, Vascular News, Annals of Vascular Diseases, and official releases.

Three worth your time:

• Sirolimus-coated balloons: SELUTION4SFA (300 patients) reached 78.6% versus 65.2% 1-year efficacy against plain balloon angioplasty (P = 0.019). A comparison with paclitaxel and longer follow-up are still missing.

• Intravascular lithotripsy below the knee at two years (DISRUPT PAD BTK II, 243 treated): 94.8% free from major amputation and 81% free from clinically driven revascularization. Single arm, manufacturer-sponsored, with high attrition.

• Pulmonary embolism: in HI-PEITHO there was no significant difference in major bleeding between catheter-directed thrombolysis and anticoagulation alone (4.0% versus 3.0%; P = 0.64). The bleeding predictors are exploratory.

Full bulletin, with a critical reading of each study and links to its sources:
https://boletinesmedicos.com/en/vascular/2026-10-12.html

#VascularSurgery #Endovascular #VenousDisease #VIVA2026 #PulmonaryEmbolism

VIVA 2026: sirolimus balloon (SELUTION4SFA, n=300) 78.6% vs 65.2% 1-year efficacy against plain balloon. Below-the-knee lithotripsy at 2 years: 94.8% free from major amputation, no control arm. Critical reading: https://boletinesmedicos.com/en/vascular/2026-10-12.html