Chronic non-healing wounds represent a significant clinical challenge, particularly in patients with systemic diseases like diabetes. This research examines macrophage efferocytosis—the process by which macrophages remove apoptotic cells—as a critical mechanism for inflammation resolution and tissue repair. In chronic wounds, impaired efferocytosis leads to inadequate clearance of apoptotic cells, prolonging inflammatory responses and delaying healing. The article reviews the molecular mechanisms governing macrophage efferocytosis during inflammation and explores clinical strategies to enhance wound healing outcomes by optimizing this cellular process.

enVVeno Medical Corporation announced that its Chief Executive Officer participated in a virtual investor discussion highlighting the company's landmark FDA Investigational Device Exemption approval. This first-ever FDA IDE approval enables enVVeno to conduct a U.S. pivotal study of its non-surgical replacement venous valve, positioning the company to develop potentially the first effective treatment for approximately three million Americans suffering from deep venous insufficiency. The transcatheter-delivered enVVe system represents an innovative bioprosthetic solution designed to restore one-way valve function and improve blood circulation. The minimally invasive procedure is performed under light sedation without requiring overnight hospitalization, addressing significant unmet clinical needs in venous disease treatment.

This article examines current limitations and future opportunities in below-the-knee (BTK) endovascular device technology through expert perspectives. Leading vascular specialists discuss device shortcomings across critical procedural phases including access, crossing, vessel preparation, and primary therapy deployment. The experts analyze technical challenges in BTK interventions and identify gaps in imaging capabilities that currently impact clinical outcomes. Their insights encompass preferred access techniques, crossing strategies, and evolving solutions such as specialized catheter techniques and atherectomy approaches. The discussion emphasizes the need for continued innovation to address unmet clinical needs in limb salvage procedures, providing valuable guidance for practitioners and device manufacturers focused on advancing BTK treatment options.

Calcified femoropopliteal arterial disease presents a significant challenge in endovascular intervention, necessitating effective vessel preparation technologies. Laser atherectomy and intravascular lithotripsy represent two prominent approaches for managing this condition prior to balloon angioplasty or drug-coated balloon therapy. Laser atherectomy employs photomechanical forces to disrupt calcified plaque, while intravascular lithotripsy utilizes sonic pressure waves to fracture calcium deposits. Clinical evidence from the Auryon system and Shockwave Medical devices demonstrates comparable safety profiles and procedural outcomes. Comparative analyses indicate that intravascular lithotripsy achieves greater immediate luminal expansion, whereas laser atherectomy produces superior luminal gain following adjunctive balloon angioplasty. Both modalities effectively reduce residual narrowing and offer reliable procedural safety, making them valuable options for optimizing treatment outcomes in calcified peripheral arterial disease.

This article presents insights from the FDA's Center for Devices and Radiological Health on contemporary clinical trial design for lower extremity revascularization, particularly in chronic limb-threatening ischemia (CLTI) populations. The discussion addresses key challenges in peripheral artery disease trials, including patient population heterogeneity, clinical complexity, and patient frailty that complicate data collection and protocol adherence. The regulatory perspective emphasizes the importance of developing clear, data-driven treatment approaches while maintaining flexibility in trial design. The examination of endpoint evolution, surrogate endpoint applications, and adaptive trial design strategies provides valuable guidance for optimizing future CLTI clinical investigations within an increasingly sophisticated regulatory framework.

Humans stand alone as the singular species with propensity to develop spontaneous DVT. Because Virchow's original description of a canine model, there has been interest in the development of animal models of thrombosis to mimic the human condition. Initial labors were directed toward development of large mammal models. The transgenic mouse era led toward efforts to translate the existing models into the smaller rodent species. Mice are amenable for the study of venous thrombosis and have the advantages of relatively low cost and the availability of different genetically manipulated strains.

This study underscores the potential of multi-objective optimization in stent design, paving the way for PAD stents that more effectively accommodate femoropopliteal biomechanics and promote favorable mechanical conditions for healing.

In patients requiring bailout stenting for FPA lesions, adjunctive DCB use was associated with lower 1-year CD-TLR; however, this finding should be considered hypothesis-generating due to the retrospective design and limited sample size. No sustained benefit was observed at 2 years. No signal for increased short-term mortality was identified, although the study was not powered for safety endpoints.

Cordis has launched the Selution SLR percutaneous transluminal angioplasty drug-eluting balloon in Japan for treating peripheral artery disease. The device delivers sirolimus in a controlled, sustained manner to reduce restenosis and restore vessel function. Clinical trial data from SELUTION SFA Japan demonstrated robust long-term outcomes, achieving 81.5% primary patency and 93.8% freedom from reintervention at three years in a complex patient population. Results were presented at the Japan Endovascular Treatment conference and published in JACC: Cardiovascular Interventions by principal investigators Yoshimitsu Soga and Osamu Iida.

This updated systematic review and meta-analysis examines the safety profile of paclitaxel-coated devices in peripheral artery disease treatment. Conducted by researchers from Nanjing Medical University, the study synthesizes evidence from randomized controlled trials to evaluate clinical outcomes and adverse events associated with these drug-coated interventional devices. The research contributes to ongoing clinical assessment of paclitaxel-eluting technology in vascular interventions, providing evidence-based insights for clinicians managing peripheral arterial disease. This comprehensive analysis addresses critical safety considerations essential for informed decision-making in peripheral vascular interventions and supports evidence-based clinical practice guidelines.

Drug-eluting stents are beneficial in treating symptomatic peripheral artery disease (PAD) in the femoropopliteal artery. Data from the ZILVER PTX trial demonstrate that paclitaxel-eluting stents had significantly better 12-month patency rates compared to traditional angioplasty with bare-metal stents for lesions in the femoropopliteal artery (above the knee).

This comprehensive Bayesian network meta-analysis evaluates endovascular treatment options for infrapopliteal artery disease, including plain balloon angioplasty, drug-coated balloons, drug-eluting and bare-metal stents, and atherectomy, with exploratory assessment of retrievable scaffold therapy. The analysis encompassed 21 randomized and 4 single-arm trials involving 3,184 patients, measuring outcomes including 30-day major adverse events, 12-month mortality, 6-month target lesion revascularization, and major amputation rates. Results indicate atherectomy ranked superior for reducing 30-day major adverse events and demonstrated significantly lower 12-month mortality compared to plain balloon angioplasty. These findings provide valuable comparative effectiveness data to inform clinical decision-making in treating infrapopliteal artery disease.

Concept Medical presented preliminary three-year data from the SIRONA randomized trial at the Charing Cross Symposium 2026, demonstrating the durability of its MagicTouch PTA sirolimus-coated balloon for treating femoropopliteal artery disease. The study compared sirolimus-coated versus paclitaxel-coated balloon angioplasty, showing superior freedom from clinically driven target lesion revascularization at three years with the sirolimus approach. The findings suggest that sirolimus-coated balloon angioplasty may provide more durable long-term outcomes than traditional paclitaxel alternatives, while maintaining comparable safety profiles with balanced all-cause mortality rates and low amputation rates across both treatment groups.

REVA Medical, LLC today announced primary endpoint results from the MOTIV BTK randomized pivotal clinical trial evaluating the MOTIV® sirolimus-eluting bioresorbable vascular scaffold in patients with critical limb-threatening ischemia (CLTI). The results were presented today at the Charing Cross International Symposium in London, UK. Motive Sirolimus- Eluting Bioresorbable Vascular Scaffold System. The MOTIV BTK trial met both its primary safety and efficacy endpoints, demonstrating that the MOTIV scaffold provides a statistically significant improvement in clinical outcomes compared to the current standard of care, balloon angioplasty.

In patients requiring bailout stenting for FPA lesions, adjunctive DCB use was associated with lower 1-year CD-TLR; however, this finding should be considered hypothesis-generating due to the retrospective design and limited sample size. No sustained benefit was observed at 2 years. No signal for increased short-term mortality was identified, although the study was not powered for safety endpoints.

In patients with chronic limb-threatening ischemia (CLTI) who have run out of treatment options, a blood flow-diverting procedure in the foot improves several measures of quality of life (QoL) in addition to lowering the risk of major amputation, according to a secondary analysis of the PROMISE III trial.At 6 months, patients reported being less bothered about poor circulation in their legs compared with before the procedure, as well as more participation in social activities, better sleeping habits, and fewer daily burdens associated with having open wounds.

enVVeno Medical has received the investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for a pivotal study involving a non-surgical replacement venous valve. The approval allows  enVVeno Medical to begin the Transcatheter Venous Valve Endoprosthesis (TAVVE) pivotal study of its enVVe system for treating severe deep chronic venous insufficiency (CVI).

The FDA’s letter indicates that, upon completing its review, it determined that it is unable to approve the PMA for VenoValve in its current form. According to a news release, the FDA indicated that the favorable revised Venous Clinical Severity Score (rVCSS) data generated by the study to show clinical improvement, together with the improvements in pain scores and venous-specific quality of life indicators, were not sufficient on their own to determine the favorability of the risk-benefit profile for VenoValve.EnVVeno Medical said that, without a specific hemodynamic measurement that correlates with patient improvement, the FDA raised concerns about bias. The agency also considered the possibility that clinical improvement occurred as a result of the patients being enrolled in a study.Additionally, the company said the FDA focused on safety concerns attributed to the associated open surgical procedure. That required rehospitalizations, the company said. However, it would not expect to see similar safety events with a non-surgical replacement valve.

“The reason for stent graft failure is neointernal hyperplasia that occurs mainly on the edge of the device and sometimes in the middle of the stent graft,” Harduin detailed. The Solaris DE covered stent is built with an impermeable electrospinning PTFE membrane to limit cellular migration, allied with the sirolimus coating to block neointimal hyperplasia and restenosis. “Sirolimus is a safe and effective cytostatic drug that has been used for a long time in interventional cardiology in coronary arteries to prevent neointimal hyperplasia, restenosis, and thrombosis,” said Harduin.Animal studies of Solaris DE have, to date, shown the persistence of the sirolimus on the outer edge of the device, he said, with one study comparing it to a conventional stent graft finding no instances of neointimal hyperplasia at 60 days following Solaris DE implantation, compared to 4.9mm3 with the conventional device.

The RFS device is a bioresorbable stent built from microfibres, providing structural support to instantly open, and facilitate the reconstruction of the artery. Due to the porous design of the implant, patients’ own cells infiltrate into the mesh, triggering the formation of new vascular tissue. While the artery is being reconstructed from the inside-out, the synthetic implant gradually resorbs and ultimately disappears over time.At LINC, Brodmann expanded on some key characteristics of the RFS. “The device is a fully electrospun tubular conduit with fibrous micro-architecture and a strutless design,” the presenter noted, also highlighting the implant’s suitability for transcatheter delivery due to a balloon-expandable design.