SELUTION SLR Highlights the Growing Role of Sirolimus Drug-Eluting Balloons in CLTI

At this year's Amputation Prevention Symposium in Boston, Thursday morning's "Hot Topics & New Data in CLTI" session began with a presentation that examined the evolving evidence supporting the SELUTION SLR sirolimus drug-eluting balloon (Cordis) as a treatment strategy for femoropopliteal and below-the-knee (BTK) peripheral arterial disease (PAD), with particular emphasis on complex chronic limb-threatening ischemia (CLTI). S. Jay Mathews, MD, MS, FACC, FSCAI, from Manatee Memorial Hospital in Bradenton, Florida, reviewed the biologic differences between sirolimus- and paclitaxel-based drug-coated technologies, positioning sirolimus as an antiproliferative agent with a wider therapeutic range, anti-inflammatory properties, and a 10,000-fold safety margin. The presentation also addressed the ongoing debate surrounding paclitaxel-coated devices, including historical safety concerns and mixed efficacy findings, before shifting focus to the expanding clinical evidence supporting sirolimus-based technology. 

Central to the discussion was the SELUTION SLR platform, which uses biodegradable polymer microreservoirs that provide controlled and sustained drug release maintain therapeutic effect in tissue for up to 90 days and proprietary cell adherent technology (CATTM) that contains and protects the microreservoirs during delivery, allowing for a maximum transfer to the vessel wall during inflation. Enhanced drug retention allows for a lower drug dose concentration on the balloon surface. 

The presentation highlighted results from the growing global SELUTION clinical program, now encompassing 10 studies and more than 1900 patients across femoropopliteal and BTK disease. Particular attention was given to the SELUTION SFA Japan trial, which enrolled a challenging patient population with high rates of diabetes, complex lesion morphology, popliteal involvement, and severe calcification. At 36 months, investigators reported sustained primary patency of 81.5% and freedom from clinically driven target lesion revascularization (TLR) of 93.8%, with durable improvements in Rutherford classification and ankle-brachial index and no target limb amputations reported during follow-up.

Dr Mathews also reviewed emerging evidence in CLTI from the PRESTIGE, PRISTINE, and PRELUDE studies, which evaluated patients with advanced disease characterized by moderate to severe calcification, long lesion lengths, diabetes, end-stage renal failure, and high amputation risk. Across these registries, the SELUTION SLR drug-eluting balloon demonstrated encouraging rates of freedom from clinically driven TLR, amputation-free survival, and wound healing despite the complexity of the treated populations. While these studies were largely nonrandomized, the consistency of outcomes across multiple cohorts suggests that sirolimus-coated balloon technology warrants continued investigation in patients with advanced infrapopliteal disease. 

The session concluded with an overview of the ongoing FDA investigational device exemption trials, including SELUTION4SFA and SELUTION4BTK. Investigators noted that these randomized studies incorporate contemporary vessel preparation techniques and novel endpoint designs, including hierarchical win-ratio analyses for BTK interventions, with the goal of generating more clinically meaningful evidence than traditional duplex ultrasound-based assessments alone. Enrollment for the femoropopliteal study has been completed, while the BTK trial continues to enroll patients.

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Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of Vascular Disease Management or HMP Global, their employees, and affiliates.