Penumbra, Inc. has received FDA clearance for its Lightning computer-assisted vacuum thrombectomy (CAVT) technology to treat deep vein thrombosis (DVT), marking a significant advancement in DVT management. The clearance is supported by results from the BOLT-DVT investigational device exemption trial, led by co-principal investigators Patrick E. Muck, MD, and Kush R. Desai, MD. The trial demonstrated that 98% of patients achieved complete or near-complete thrombus removal with a median device time of 18 minutes and a 48-hour major adverse event rate of 3.1%. Notably, the therapy produced a low rethrombosis rate and delivered rapid clot removal with durable pain relief and improved quality of life. This represents the first FDA clearance for mechanical thrombectomy in DVT treatment, addressing a significant clinical gap. For decades, anticoagulation has remained the standard DVT treatment, primarily preventing clot progression rather than removing existing clots. CAVT offers clinicians evidence-based justification for advanced intervention as a first-line option for acute iliofemoral DVT, potentially transforming treatment protocols and improving patient outcomes.

This study evaluated drug-coated balloons (DCBs) for treating symptomatic and recurrent central venous lesions, including in-stent restenosis and occlusion, in hemodialysis patients. Researchers analyzed 27 patients treated with DCBs between June 2021 and September 2025, examining overall efficacy, outcomes of repeated applications, and factors influencing patency. Results demonstrated significant improvement in target lesion patency at six months following initial DCB use, increasing from 30% to 77% (p <0.0001). Repeated DCB applications maintained comparable efficacy between first and second uses. Subgroup analysis revealed a trend toward better patency rates when peripheral cutting balloons (PCBs) were used for pre-dilatation compared to conventional balloons, though this difference was not statistically significant. The study concludes that DCBs offer satisfactory efficacy for recurrent central venous lesions with sustained effectiveness upon repeated use, while PCB pre-dilatation shows promise for potentially improving patency outcomes.

Peripheral artery disease affects approximately 236 million persons worldwide and is diagnosed with an ankle–brachial index of less than 0.90. Among older persons, 3.3% of those without peripheral artery disease, 18.1% with mild disease, and 52.0% with severe disease could not complete a 6-minute walk test without resting. To prevent cardiovascular events in persons with peripheral artery disease, intensive cholesterol-lowering medications (statins), antiplatelet medications or low-dose aspirin with rivaroxaban, blood-pressure lowering to less than 130/80 mm Hg, and semaglutide are recommended, along with sodium–glucose cotransporter 2 inhibitors in patients with diabetes. Supervised walking exercise and structured home-based walking exercise each improve walking ability in persons with peripheral artery disease. Revascularization in the legs should be reserved for those with persistent disease symptoms that do not respond to exercise.

Hybrid procedures combining endovascular and surgical techniques represent an increasingly important treatment approach for peripheral arterial disease, a condition affecting blood flow to the limbs. This analysis examines the clinical outcomes of hybrid interventions that integrate minimally invasive catheter-based endovascular methods with traditional open surgical reconstruction. These combined approaches address complex arterial lesions that may not be suitable for single-modality treatment, particularly in patients with extensive atherosclerotic disease affecting multiple vessel segments. The research evaluates procedural success rates, limb salvage outcomes, patency rates, and complication profiles across various hybrid configurations. Key findings demonstrate that hybrid procedures achieve favorable long-term results in selected patient populations, with improved clinical outcomes compared to either modality used independently. The significance of this research lies in establishing hybrid techniques as a viable therapeutic option that optimizes treatment selection for peripheral arterial disease, potentially reducing amputation rates and improving functional outcomes while minimizing patient morbidity compared to extensive open surgery alone.

# Summary This research article presents a comparative analysis of three interventional techniques for treating arterial stenosis: atherectomy, drug-eluting balloons, and drug-eluting stents. The study evaluates the efficacy and safety profiles of these distinct approaches in managing vascular obstruction. Atherectomy mechanically removes plaque buildup from arterial walls, while drug-eluting balloons deliver therapeutic agents during angioplasty without permanent implantation. Drug-eluting stents provide scaffold support while releasing medications to prevent restenosis. The comparative analysis examines clinical outcomes including restenosis rates, vessel patency, procedural success, and adverse events across these modalities. Understanding the relative benefits and limitations of each technique is critical for interventional cardiologists and vascular specialists in selecting optimal treatment strategies for individual patients. The findings contribute to evidence-based practice by clarifying which approaches yield superior outcomes in specific clinical scenarios, ultimately improving patient selection and treatment outcomes in peripheral and coronary interventions.

Stryker Peripheral Vascular announced that the American Medical Association's CPT Editorial Panel has approved a category I CPT code for transcatheter arterialization of deep veins (TADV) using Stryker's LimFlow system. This advancement represents a significant milestone, elevating the procedure from its previous category III coding status. The category I designation acknowledges TADV as an established procedure supported by growing clinical evidence, expanding physician adoption, and consistent utilization patterns. This reclassification strengthens the infrastructure supporting patient access to the therapy. The LimFlow system received FDA approval in September 2023 for treating chronic limb-threatening ischemia in patients with no suitable revascularization alternatives who face major amputation risk. The new CPT coding will facilitate reimbursement and broader clinical implementation of this innovative endovascular solution.

The Cardiovascular and Interventional Radiology Society of Europe (CIRSE) has published comprehensive Standards of Practice Guidelines for the endovascular management of acute lower limb ischaemia. Released in September 2026, these guidelines provide evidence-based recommendations for interventional radiologists and vascular specialists managing this time-sensitive condition. The document addresses peripheral and aortic interventions, establishing standardized protocols for diagnosis, patient selection, and treatment approaches. By offering clear clinical pathways and best practice standards, these guidelines aim to improve consistency and outcomes in endovascular intervention for acute lower limb ischaemia across European healthcare systems. The open-access publication ensures broad accessibility for practitioners and institutions, facilitating implementation of standardized care protocols. These standards are significant as they help reduce complications, optimize patient outcomes, and establish uniform quality benchmarks for this critical vascular emergency, ultimately benefiting patients requiring urgent intervention for limb-threatening ischemia.

# Revascularization in Diabetic Foot Ulcers with Peripheral Artery Disease Recent clinical trials have substantially advanced understanding of optimal revascularization strategies for diabetic patients with foot ulcers and peripheral artery disease. The BEST-CLI and BASIL-2 trials provide critical evidence comparing bypass surgery and endovascular therapy approaches. These landmark studies demonstrate that treatment selection should be individualized based on patient anatomy, lesion characteristics, and clinical presentation rather than relying on a one-size-fits-all approach. Key findings reveal that while endovascular interventions offer initial advantages in accessibility and reduced operative burden, bypass surgery may provide superior long-term patency and limb salvage outcomes in certain patient populations. The research emphasizes the importance of complete revascularization to address the complex vascular pathology underlying diabetic foot ulcers. These insights inform clinical decision-making for vascular specialists managing this challenging patient population, ultimately improving amputation prevention rates and patient outcomes in diabetes-related peripheral vascular disease.

This clinical study evaluates a paclitaxel-coated balloon for treating femoropopliteal artery disease, a peripheral arterial condition affecting blood flow in the leg. The research examines the BIOtorcin device, a drug-coated balloon designed to deliver the antiproliferative agent paclitaxel directly to diseased arterial tissue to prevent restenosis. The investigation employs a rigorous methodology including pharmacokinetic sampling and bioanalysis to measure drug exposure and systemic absorption following balloon angioplasty procedures. Clinical endpoints assess both the efficacy of the intervention and participant safety throughout follow-up periods. The study establishes baseline characteristics across participant demographics, laboratory values, and lesion morphology to ensure comprehensive analysis. Procedural details and quantitative angiography data document technical performance and vessel response. This research is significant because drug-coated balloons represent an innovative therapeutic approach to reduce restenosis rates in peripheral arterial interventions, potentially improving long-term outcomes and reducing the need for repeat procedures in patients with femoropopliteal disease. The findings contribute important clinical evidence supporting this minimally invasive treatment strategy.

Two experienced vascular specialists discuss the clinical applications and advantages of the Rotarex™ Catheter System, a rotational atherectomy device designed to treat various peripheral artery disease lesions. Dr. Kousta Foteh, Chief of Vascular Surgery at Vital Heart and Vein in Houston, and Dr. James D. Joye, an interventional cardiologist based in Northern California with nearly three decades of experience, highlight the device's versatility in addressing acute thrombus, chronic thrombus, and mixed-etiology fibrothrombotic plaques. Dr. Foteh emphasizes that the Rotarex™ System has become his preferred atherectomy tool due to its ability to manage multiple lesion types across the spectrum of peripheral artery disease severity, from intermittent claudication to chronic limb-threatening ischemia. Dr. Joye underscores two key benefits: straightforward setup that is easy for clinical staff to manage, and importantly, minimal occurrence of slow flow and downstream debris when used appropriately, compared with alternative treatment options. The discussion is contextualized through a clinical case of a man in his early seventies presenting with lifestyle-limiting claudication and an occluded superficial femoral artery stent placed eight years earlier, demonstrating real-world application of the technology in managing complex vascular interventions.

Researchers compared two vessel preparation techniques for drug-coated balloon (DCB) angioplasty in patients with femoropopliteal atherosclerotic disease. The study evaluated scoring balloon (SB) preparation against plain balloon (PB) preparation across two Chinese tertiary centers from 2022-2025, involving 126 matched patients (63 per group). Scoring balloon preparation significantly reduced target vessel dissection rates from 49.2% in the plain balloon group to 17.5%, with an odds ratio of 5.00. Additionally, bailout stenting rates decreased substantially, from 31.7% with plain balloons to 9.5% with scoring balloons. While procedural complications showed similar rates between groups, twelve-month primary patency rates were comparable at 87.3% versus 88.9%, and freedom from clinically driven target vessel revascularization showed no significant difference. The findings suggest that scoring balloon preparation offers immediate procedural advantages by reducing vessel injury and need for emergency stenting, though mid-term clinical outcomes remain equivalent, supporting its use as an optimal vessel preparation strategy for DCB angioplasty.

The PROMISE III trial evaluated transcatheter arterialization of the deep veins (TADV) using the LimFlow system (Stryker Peripheral Vascular) as a treatment for chronic limb-threatening ischemia in patients unsuitable for conventional revascularization. Presented at VIVA 2026 by Dr. Daniel G. Clair, the prospective, multicenter, single-arm study enrolled 100 patients with 103 limbs, all classified as Rutherford class 5 or 6 with nonhealing ulcers or gangrene. The cohort was medically complex, with high prevalence of diabetes (80%), hypertension (95%), and chronic kidney disease (46%). An independent clinical events committee monitored safety outcomes while a core laboratory analyzed wound healing. At one year, the trial demonstrated sustained limb preservation, wound healing, and symptom improvement in this high-risk, no-option population. These findings build upon earlier PROMISE study results, suggesting TADV with the LimFlow system offers meaningful clinical benefits for patients with severe limb-threatening ischemia who lack alternative revascularization options, addressing a critical unmet need in advanced peripheral vascular disease management.

Arteriovenous fistulas (AVFs) are the preferred vascular access for hemodialysis, but venous stenosis significantly limits long-term patency. Drug-coated balloons (DCBs) such as the IN.PACT™ AV paclitaxel-coated balloon have emerged as promising treatments to reduce restenosis by inhibiting neointimal hyperplasia. However, clinical outcomes remain inconsistent, potentially due to the unique hemodynamic environment of AVFs characterized by high flow, turbulent shear stress, and alternating vessel segments. Researchers from Wake Forest University investigated how tissue type and AVF-specific hemodynamics affect paclitaxel retention using an ex vivo bioreactor system with porcine venous and arterial samples. After two-minute balloon deployments, paclitaxel concentrations were measured at 1 and 24 hours, with scanning electron microscopy assessing coating deposition. Results revealed no statistically significant difference in drug retention between tissue types, though venous samples showed greater variability and distinct coating patterns. This study provides an important mechanistic evaluation platform for understanding catheter-based drug delivery in vascular access, potentially informing optimization of DCB therapy for improved AVF outcomes.

Arteriovenous fistula (AVF) restenosis following percutaneous transluminal angioplasty (PTA) represents a significant complication affecting hemodialysis access in maintenance hemodialysis patients. This retrospective cohort study of 241 patients treated between July 2022 and July 2025 aimed to identify independent risk factors and develop a predictive model for AVF restenosis within 12 months post-PTA. Researchers used univariate and multivariate logistic regression analysis, employing the SMOTE algorithm to address data imbalance inherent in the original dataset of 45 restenosis cases versus 196 non-restenosis cases. The analysis identified multisegmental stenosis, cannulation method, platelet count, and C-reactive protein as key independent risk factors. The resulting SMOTE-based model achieved excellent discriminatory performance with an AUC of 0.934 on the training set and 0.868 on the validation set, substantially outperforming the original model. While this internally validated tool demonstrates promising predictive capability for clinical decision-making, the authors emphasize it requires external validation before routine clinical implementation to confirm real-world applicability and reliability.

Abbott's Esprit below-the-knee drug-eluting resorbable scaffold (DRS) demonstrated favorable safety and effectiveness outcomes in chronic limb-threatening ischemia patients, according to six-month results from the Esprit BTK Post-Approval Study presented at VIVA 2026. The prospective, multicenter observational study enrolled 210 patients across 50 global sites, with current analysis covering the first 200 participants. The Esprit BTK scaffold delivers everolimus while providing temporary vessel support before resorbing completely, leaving no permanent implant. At baseline, the cohort was notably complex, with 63% having Rutherford class 5 or 6 disease, 77% diabetic, 64% with index wounds, and 59% of lesions showing moderate-to-severe calcification. At six months, freedom from clinically driven target lesion revascularization reached 93.8%, while the composite rate of major adverse limb events and perioperative death was 5.5%. Amputation-free survival was 88%, with 52.9% achieving complete wound healing. These outcomes build on the preceding LIFE-BTK randomized trial, which established the scaffold's superiority over angioplasty alone, positioning the Esprit BTK as a significant advancement for treating complex infrapopliteal disease.

The antegrade approach is the standard first-line method for treating femoropopliteal chronic total occlusions endovascularly, yet technical failure frequently occurs in long-segment lesions due to guidewire subintimal tracking and difficulty re-entering the true lumen. Modern crossing algorithms emphasize thorough anatomical evaluation of proximal and distal caps, collateral networks, and distal reconstitution zones. When antegrade approaches fail, retrograde tibiopedal access provides a mechanically advantageous alternative from a different angle. Montero-Baker et al. achieved 86.3% revascularization success using retrograde approaches in complex popliteal and tibioperoneal occlusions previously resistant to antegrade crossing. Walker et al.'s multicenter registry of 197 patients demonstrated 93.4% successful access rates and 85.3% overall crossing success, with 82.8% success even among patients with prior failed antegrade attempts. This case illustrates successful retrograde crossing via distal anterior tibial artery access following failed antegrade attempts, with wire externalization through the proximal guiding catheter enabling standard balloon therapy. The case highlights use of a sheathless technique for distal artery puncture, endorsed by a 2024 international position statement to preserve structural integrity of delicate distal run-off vessels. These findings establish distal retrograde access as a rational, highly effective strategy rather than merely a last-resort procedure.

The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface has demonstrated superior performance in treating long superficial femoral artery (SFA) lesions, addressing a significant clinical challenge. While conventional interventions including drug-eluting stents, drug-coated balloons, and bare metal stents typically show declining patency rates as lesion length increases, the VIABAHN device maintains consistent efficacy independent of lesion complexity. A prospective, multicenter study across 64 sites followed patients for five years following initial one-year post-market surveillance data. Results showed sustained patency through the five-year period with high freedom from target lesion revascularization rates at both one and five years. Six-year imaging follow-up confirmed maintained patency despite progressive popliteal disease from chronic atherosclerosis. The device demonstrated an acceptable safety profile throughout the extended follow-up period. These findings, published in Vascular Medicine journal, suggest the VIABAHN endoprosthesis represents a durable solution for challenging SFA disease with long lesions, potentially reducing the need for repeat interventions compared to alternative treatment modalities.

The Transcatheter Cardiovascular Therapeutics (TCT) 2026 conference will showcase 28 late-breaking clinical presentations across six sessions from November 1-3 at the San Diego Convention Center, delivered in collaboration with leading medical journals including The Lancet, Circulation, and the New England Journal of Medicine. The programme spans coronary intervention, structural heart disease, peripheral vascular intervention, renal denervation, and antithrombotic strategies, featuring randomised trials, post-approval evidence, and real-world analyses. Five standout studies include PROGRESS, examining TAVR versus clinical surveillance in 2,250 moderate aortic stenosis patients; PIONEER IV, comparing angiography-derived FFR guidance with standard care in 2,540 PCI participants; CLASP II TR, evaluating transcatheter tricuspid valve repair using the PASCAL system in 1,270 patients; SIMPLAAFY, investigating antithrombotic monotherapy post-left atrial appendage occlusion in 1,857 subjects; and HD-PCI, a 16,000-patient trial comparing heparin dosing during PCI. Additional presentations include P4 Trial comparing coronary CT angiography-guided versus IVUS-guided PCI in 1,090 patients, and TRANSFORM II evaluating sirolimus-coated balloons against drug-eluting stents in 1,820 patients. Radcliffe Cardiology will provide comprehensive editorial coverage including trial summaries and expert analysis.

Drug-coated balloons represent an advancing treatment option for maintaining vascular patency in dialysis patients. Traditional balloon angioplasty, while minimally invasive, often results in restenosis requiring repeated interventions. Drug-coated balloons (DCB) address this limitation by coating the balloon surface with paclitaxel, which inhibits smooth muscle cell proliferation when released during vessel expansion. Clinical research, including presentations at the 2024 Charing Cross International Conference in London and three studies published in vascular surgery journals in 2026, demonstrates that DCBs significantly reduce restenosis rates compared to plain balloon angioplasty. Studies show approximately 20-30% reduction in restenosis risk and 15-20% improvement in one-year vessel patency rates. While DCBs offer superior long-term vessel maintenance and reduced need for repeat interventions, they carry higher costs and require out-of-pocket payment for dialysis applications. However, treatment efficacy may diminish over time, and outcomes vary among individual patients. Selection should consider stenosis location, length, and intervention frequency, determined in consultation with medical teams.

This retrospective single-center study evaluated the comparative effectiveness of drug-coated balloons (DCBs) and drug-eluting stents (DESs) for treating femoropopliteal artery lesions in patients with chronic limb-threatening ischemia (CLTI). Conducted between January 2018 and December 2022, the analysis included 166 patients with Rutherford Class 5 or 6 wounds undergoing endovascular therapy, with 53 matched pairs compared via propensity score matching. Primary outcomes measured complete wound healing without death or major amputation, primary patency, and freedom from target lesion revascularization at one year. Results demonstrated no statistically significant differences between DCB and DES groups: complete wound healing rates were 84.8% versus 80.2% respectively, primary patency 69.4% versus 75.6%, and freedom from target lesion revascularization 78.6% versus 78.0%. Multivariate analysis identified hemodialysis dependence and advanced Wound, Ischemia, and foot Infection Stage 4 as negative predictors of healing, while higher Global Limb Anatomic Staging System grades positively correlated with outcomes. These findings suggest both devices offer comparable efficacy for CLTI management, potentially allowing clinicians greater flexibility in device selection based on individual patient characteristics and anatomical considerations.