At VIVA 2026 in Las Vegas, the VIVA Foundation presented late-breaking clinical trial results advancing peripheral vascular disease treatment. The SELUTION4SFA trial compared the SELUTION SLR drug-eluting balloon (DEB) to standard balloon angioplasty (PTA) for treating superficial femoral and proximal popliteal artery lesions in symptomatic peripheral artery disease patients. This prospective, multicenter, randomized controlled study enrolled 300 subjects across 34 clinical sites in the United States, Europe, and Asia, with 205 patients receiving the SELUTION SLR DEB and 95 receiving conventional PTA. The trial demonstrated that SELUTION SLR DEB achieved superior efficacy at 12 months with 78.6% primary patency compared to 65.2% for PTA (p=0.019), and met non-inferiority safety endpoints with 92.8% versus 84.2% (p<0.0001). Kaplan-Meier estimates showed 90.3% primary patency and 94.6% freedom from clinically-driven target lesion revascularization for DEB versus 79.4% and 85.3% for PTA respectively. These results underscore the clinical significance of drug-eluting balloon technology in improving outcomes for peripheral artery disease patients.

Serration Remodeling Therapy (SRT) addresses critical challenges in treating peripheral artery disease affecting the feet, particularly in complex cases. A case presentation in Endovascular Today by Dr. Melissa Keller, PhD, demonstrates SRT's clinical application in a diabetic patient with critical limb-threatening ischemia (CLTI) and severe pedal artery disease complicated by a non-healing wound. SRT provides controlled vessel expansion in small, calcified vessels while eliminating typical complications such as elastic recoil and residual waist formation. This technique represents a significant advancement for limb salvage interventions, offering predictable luminal expansion outcomes where conventional endovascular approaches face limitations. The innovation highlights the importance of understanding emerging evidence, clinical expertise, and market developments in peripheral vascular intervention, particularly for addressing the challenging anatomy of pedal arteries in diabetic patients requiring wound healing and tissue preservation.

Researchers addressing a critical limitation in stent-based cardiovascular treatment have developed a novel therapeutic approach that decouples restenosis prevention from vascular healing complications. Traditional drug-eluting stents reduce neointimal hyperplasia by suppressing vascular smooth muscle cell proliferation, but this cytostatic mechanism delays re-endothelialization and impairs vascular repair. An international collaboration involving institutions including Asan Medical Center, Chung-Ang University, McGill University, and Ajou University proposes an innovative regenerative scaffold strategy designed to maintain antirestenotic efficacy while promoting healthy vascular healing. Published in Theranostics in January 2027, this research addresses a fundamental therapeutic tradeoff that has limited stent-based revascularization effectiveness. By employing a regenerative scaffold approach rather than relying solely on cytostatic drug delivery, the study aims to achieve both restenosis prevention and optimal vascular repair simultaneously. This advancement has significant implications for improving long-term outcomes in interventional cardiology and reducing restenosis-related complications that currently necessitate repeat revascularization procedures in many patients.

The BOLT-DVT study, a prospective multicenter trial presented at VIVA 2026, demonstrates that computer-assisted vacuum thrombectomy (CAVT) using Penumbra's Indigo aspiration system successfully treats acute iliofemoral deep vein thrombosis. The investigational device exemption study enrolled 229 patients across 39 U.S. sites with a mean age of 58.1 years. Results showed that 98 percent of evaluable patients achieved complete or near-complete (≥75 percent) thrombus reduction in the target venous segment, meeting the primary effectiveness endpoint. The primary safety endpoint was also achieved, with a 48-hour composite major adverse event rate of only 3.1 percent and no device-related deaths or serious device-related adverse events reported. Major bleeding occurred in 1.3 percent of patients, symptomatic pulmonary embolism in 0.9 percent, and rethrombosis in 1.3 percent. Procedural efficiency was notable, with a median device time of 18 minutes and 99.1 percent of cases completed in a single session. At 30 days, Villalta scores improved significantly from 11.0 to 1.0, indicating meaningful symptom reduction. These findings support CAVT as a viable first-line treatment option for acute iliofemoral DVT, with longer-term outcomes under evaluation through two years of follow-up.

Haemonetics Corporation announced FDA approval of its PerQseal Elite vascular closure system for large-bore arterial procedures, marking a significant expansion of the company's closure device portfolio following its January 2026 acquisition of Vivasure Medical Limited. The PerQseal Elite system offers sutureless vascular closure for structural heart and endovascular procedures using 14- to 22-F sheaths, with a fully bioabsorbable patch that seals arteriotomies up to 26 F from within the vessel. Clinical data from the prospective, multicenter ELITE arterial study showed zero major complications per Valve Academic Research Consortium-3 criteria and mean hemostasis time under one minute. The device previously received CE Mark approval in Europe for both arterial and venous applications in 2025. According to Professor Nicolas van Mieghem, coinvestigator of the ELITE trial and interventional cardiologist at ZOL Hospital in Belgium, the device demonstrates intuitive usability and rapid hemostasis integration into procedural workflows. Haemonetics will present additional clinical data at the Transcatheter Cardiovascular Therapeutics scientific symposium this fall.

Reva Medical presented subgroup analysis results from its pivotal MOTIV BTK trial evaluating the Motiv sirolimus-eluting bioresorbable vascular scaffold for treating below-the-knee peripheral artery disease at VIVA 2026. The prospective, randomized controlled trial enrolled 292 patients with chronic limb-threatening ischemia, predominantly Rutherford class 5 severity. The subgroup analysis compared Motiv scaffold outcomes against standard balloon angioplasty across different disease severity categories. Results demonstrated that Motiv achieved superior composite endpoints of limb salvage and primary patency at both six and twelve months compared to angioplasty in each Rutherford classification group. The device also showed higher acute technical and procedural success rates, with particularly pronounced advantages in the more complex Rutherford class 5 cohort. A live procedure demonstration featured the device performing BTK revascularization in a 72-year-old patient with Rutherford class 5 disease. The trial previously met its primary safety and efficacy endpoints for treating complex infrapopliteal arterial disease, positioning the bioresorbable scaffold as a promising advancement in peripheral vascular intervention.

Instylla, Inc. announced FDA approval for an expanded indication of its Embrace hydrogel embolic system (HES) to treat peripheral arterial bleeds in vessels up to 6 mm, broadening its initial August 2025 approval for hypervascular tumor embolization in smaller vessels. The Embrace HES launched commercially in January 2026 and represents a resorbable embolic solution designed for peripheral vascular embolization. The expanded approval was supported by data from the HALT trial, a prospective, multicenter study that enrolled 130 patients across 22 U.S. sites beginning January 2023. The trial met its primary endpoints with 100% freedom from major adverse events and 90.0% clinical success rate, defined as no rebleeding at 30 days. Key advantages of the Embrace HES include its ability to enable both distal and proximal embolization with a single agent, precise delivery control, and preserved microcatheter access post-embolization—distinguishing features that clinicians note reduce nontarget embolization risk. This expanded indication addresses an important clinical need in interventional radiology, offering physicians a versatile, safety-focused option for managing peripheral arterial bleeding complications.

Palmetto GBA has implemented LCD L40228, governing endovascular management for peripheral arterial disease affecting the upper and lower extremities across seven southeastern states (Alabama, Georgia, North Carolina, South Carolina, Tennessee, Virginia, and West Virginia), effective April 12, 2026. This comprehensive 2,934-word policy establishes coverage criteria and billing requirements, with accompanying billing and coding article A60247 detailing 212 ICD-10-CM diagnosis codes supporting medical necessity for 70 procedure codes, including established techniques such as 0237T, 0238T, 37184, 37185, and 37236 among others. The policy represents the only local coverage determination published under this specific title among Medicare contractors. Critical for revenue cycle management, claims must satisfy both the policy's coverage requirements and NCCI editing rules when multiple procedure codes are billed simultaneously. This determination significantly impacts claims processing for endovascular interventions in the affected region, requiring providers to reference the current Medicare Coverage Database for accurate diagnosis-procedure code pairing validation to ensure claim payment.

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.