“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.

The BARISTA trial, led by Lieven Maene (Onze Lieve Vrouw, Aalst, Belgium), enrolled 200 patients with all types of iliac lesions. Significantly, 34% of the study population presented with TASC C and D lesions, representing more complex anatomical scenarios and underscoring the robustness of the clinical evaluation.At one-year follow-up, the trial demonstrated positive clinical outcomes: Freedom from target lesion revascularisation (fTLR): 96.4% Freedom from restenosis: 94.1%

Launched in Europe in 2016 and the USA two years later following successful results from the IMPERIAL randomised controlled trial (RCT),1 the Eluvia DES is designed to provide sustained drug release and efficient drug transfer with the aim of overcoming the challenge of restenosis in the superficial femoral artery (SFA).Steiner’s clinical experience with the Eluvia DES dates back several years. At this time, she and colleagues conducted the BEST-SFA RCT, in which Eluvia was used as a comparator. “What we observed in this analysis, and in our own clinical experience, was that the stent performed very well, effectively inhibiting the need for reintervention.” Steiner recalls. Two-year results of this study were published in 2024 in JACC: Cardiovascular Interventions.2

LUMIFOLLOW is a multicentre, real-world registry including 542 patients from 15 centres in France. The study reflects routine clinical practice and includes a broad spectrum of lesion complexity. Notably, 43.6% of lesions were classified as TASC C and D, and 24.2% of treated cases were restenotic lesions, underlining the challenging nature of the population evaluated.At three years, 87.3% of patients remained free from revascularisation, confirming durable treatment effect, states the company. No device-related safety concerns were reported during the follow-up period.

Retrievable scaffold therapy (RST) with the Spur® peripheral retrievable scaffold system (Reflow Medical; Figure 1) represents a novel approach to BTK CLTI treatment. The Spur system consists of a retrievable nitinol scaffold with radial spikes integrated onto a balloon delivery platform. The radial spikes are designed to penetrate the lesion and vessel wall in a controlled manner, reduce recoil, change vessel compliance, and create channels that enhance drug uptake to the adventitia (Figure 2).15 Following Spur RST, commercially available DCBs are applied to provide long-term patency.16–18 This combined strategy is intended to deliver stent-like results while leaving nothing behind.

The academic, all-comers SirPAD trial enrolled 1,252 patients with femoropopliteal or below-the-knee PAD who were randomized to receive either the sirolimus-coated balloon MagicTouch PTA or any uncoated balloon angioplasty. The primary outcome of major adverse limb events (MALE), encompassing major unplanned amputations affecting the target limb or target-lesion revascularization for critical ischemia, occurred in 8.8% of patients enrolled in the sirolimus-coated balloon group vs. 15% in the uncoated balloon group at one year, corresponding to a median unbiased estimate of the risk difference of -4.9%. This difference was both noninferior and superior in favour of MagicTouch PTA (Concept Medical Inc.) vs. uncoated balloon. Furthermore, the authors showed a statistically significant reduction in the composite key secondary endpoint of any unplanned target-limb amputation or any target limb revascularization.

12 Month Outcomes of the SUCCESS PTA Study show consistent safety and effectiveness in claudicant and CLTI patients when using the SELUTION SLR™ drug eluting balloon.

RNA-seq identified downregulation of the Hedgehog signaling pathway in CARMN-KO models and revealed that CARMN regulates this pathway through its downstream miRNA, miR-143-3p, which targets Hedgehog-interacting protein (HHIP), an antagonist of Hedgehog signaling. Delivery of HHIP-specific siRNA or miR-143-3p mimics rescued EC angiogenic defects and improved blood flow recovery in both CARMN-KO and WT mice. These findings underscore the critical role of CARMN in modulating angiogenesis through the miR-143-3p-HHIP-Hedgehog signaling axis, providing insights into SMC-EC interactions and potential therapeutic strategies for CLTI.

Until this recent Health Canada approval for the Esprit BTK system, Abbott notes that the standard of care has been balloon angioplasty. However, the company notes that treatment with balloon angioplasty alone can have poor short- and long-term results, and—in many instances—the vessels do not remain patent, requiring additional treatment.

Sahil Parikh (Columbia University Irving Medical Center, New York, USA) reported that, at three years, Esprit BTK demonstrated a 33% relative improvement in the composite primary efficacy endpoint of primary patency and limb salvage compared to percutaneous transluminal angioplasty (PTA; 59.5% vs. 44.8%; p=0.0025 log rank test). Parikh added that the Esprit BTK was also associated with significantly lower rates of binary restenosis (38% vs. 49%; p=0.018 log rank test), and lower clinically driven target lesion revascularisation (CD-TLR) rates, though the latter did not reach statistical significance (10.2% vs. 18.4%; p=0.052 log rank test). Furthermore, the presenter shared that safety outcomes, the composite of freedom from major adverse limb events at three years, and perioperative death at 30 days were similar between the two arms (90.8% vs. 94.2%; p=0.23 log rank test).  

Drug-coated balloons and stents don’t reduce the risk of amputation or improve quality of life for people with peripheral artery disease in the legs. That’s the takeaway from two major clinical trials led by researchers at the University of Gothenburg.

“Endovascular thrombectomy has transformed acute ischaemic stroke care, with onset-to-puncture [OTP] time widely recognised as a critical determinant of outcome,” the authors write, outlining the backdrop to their study. “However, emerging evidence suggests that in-hospital procedure time—from arterial puncture to final recanalisation—may have an equally or more significant impact.”

For patients with compromised limb viability, such as acute and chronic limb-threatening ischaemia, or severe functional impairment that does not improve with exercise training, lower extremity revascularization is recommended. Given the complexity of PAD management, a multidisciplinary vascular team is required to achieve the best individualized treatment. Further research efforts should focus on reducing ischaemic events and health disparities and on optimizing the implementation of GDMT and exercise therapy, as well as improving the quality of life in patients with PAD.

A press release details that AMBITION BTK is a prospective, multicentre, randomised controlled trial (RCT) designed to investigate the clinical safety and effectiveness of the Auryon atherectomy system combined with standard balloon angioplasty, compared to balloon angioplasty alone, in treating infrapopliteal lesions in patients with CLTI. The primary endpoint will be evaluated using a win-ratio approach, comparing the two treatment groups based on the following components in a hierarchical manner at 12 months: freedom from major amputation, freedom from clinically driven target lesion revascularisation (CD-TLR), and primary patency.

According to Reflow Medical, the Spur stent system is the first and only retrievable stent system that features a self-expanding stent with an integrated dilatation balloon catheter on an over-the-wire system. It is designed for controlled lesion penetration and treatment through a series of radially expandable spikes. Known as retrievable scaffold therapy (RST), the spikes on the Spur stent penetrate the lesion to increase the acute luminal diameter and modify the lesion morphology to change vessel compliance and reduce vessel recoil effect.

A new statement from leading heart and blood vessel experts in Europe is providing clinical guidance for treatments to prevent blood clots in patients with a serious condition called chronic limb-threatening ischemia (CLTI), after they have had procedures to restore blood flow in their lower limbs. The statement, and the systematic review it is based on, comes from the European Society of Cardiology (ESC) Working Group on Aorta and Peripheral Vascular Diseases and Working Group on Cardiovascular Pharmacotherapy.

StentIt’s RFS device is a bioresorbable stent built from microfibers, providing structural support to instantly open, and facilitate the reconstruction of the artery. Due to the porous design of the implant, patient’s 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. 

In Wednesday’s peripheral arterial programme, which hosted several podium-first presentations, lower limb drug-eluting technologies took centre stage—signalling a potential shift in the treatment paradigm for chronic limb-threatening ischaemia (CLTI). Investigators shared compelling new data from studies ranging from first-in-human trials to large-scale registries, which vie to redefine durability and safety, as well as cost-effectiveness, in the peripheral arterial treatment landscape.

Critical Limb Ischemia (CLI) is a condition manifested by pain at rest, a non-healing wound, or gangrene. It occurs due to severe blockages in the arteries of a person’s lower extremities/limbs (legs), which markedly reduces blood flow. This condition is a serious form of Peripheral Arterial Disease or PAD that is caused by the buildup of fats, cholesterol or some other substances in and around your artery walls.