Endovascular treatment has become first line therapy for the treatment of femoropopliteal disease. Drug-coated devices play a key role in maintaining vessel patency. In the past antiproliferative coating of drug-coated balloons (DCBs) exclusively consisted of paclitaxel. Use of limus drugs was limited by a short residency time in the vessel wall. Besides the drug, the SELUTION SLR™ drug-eluting balloon system consists of a coating formulation of four excipients. The first excipient is a biodegradable polymer (poly(lactic-co-glycolic acid)) that is intermixed with the sirolimus to form micro-reservoirs and regulates drug release via matrix degradation. This review summarizes the existing pre-clinical and clinical literature on treatment of femoropopliteal artery lesions with the SELUTION SLR DCB.
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http://dx.doi.org/10.2217/fca-2020-0085 | DOI Listing |
J Clin Med
January 2025
Department of Vascular and Endovascular Surgery, Rhein Main Vascular Center, Asklepios Clinics Langen, Paulinen Wiesbaden, 63225 Langen, Germany.
: Sirolimus-coated balloons (SCBs) have emerged as a promising alternative to paclitaxel-coated devices for the treatment of femoropopliteal lesions. However, real-world data on SCB performance in also complex peripheral arterial disease remains unknown. We sought to evaluate the safety and 12-month clinical outcomes of the Selution SLR™ balloon angioplasty in a challenging real-world patient cohort.
View Article and Find Full Text PDFCardiovasc Intervent Radiol
July 2024
Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore.
Purpose: The aim of PRISTINE was to evaluate the 6 and 12 months safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon for treatment of complex lower limb occlusive lesions (TASC II C & D) in patients with chronic limb threatening ischemia (CLTI) from Singapore.
Methods: PRISTINE was a prospective, non-randomized, single arm, observational, multi-investigator, single-center clinical study. Complication-free survival at 30 days was the safety clinical endpoint.
JACC Cardiovasc Interv
July 2024
Department of Cardiology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan.
Background: Sirolimus-coated balloons (SCB) for the treatment of femoropopliteal (FP) lesions have not been systematically studied, but initial outcomes from early studies are promising.
Objectives: The authors sought to evaluate the safety and efficacy of the SELUTION SLR SCB, composed of proprietary microreservoir technology combining sirolimus and biodegradable polymer, when used to treat mild-to-moderate FP disease in a Japanese population.
Methods: This multicenter, prospective, single-arm study (SELUTION SFA JAPAN) enrolled 134 patients with FP disease.
J Endovasc Ther
December 2023
Catheterization Laboratory, Montevergine Clinic, Mercogliano, Italy.
Purpose: The aim of this study was to assess the efficacy and safety of the novel SLR (SELUTION sustained-limus-release) drug-coated balloon (DCB) in the treatment of the femoropopliteal steno-occlusive disease.
Materials And Methods: From February 2021 to March 2022, 80 consecutive patients (age: 69.5±8.
Pharmaceutics
June 2023
Bioengineering Research and Development Centre (BioIRC), Prvoslava Stojanovića 6, 34000 Kragujevac, Serbia.
The possibility of injectable biomaterials being used in the therapy of peripheral artery disease (PAD) is investigated in this article. We conducted a thorough review of the literature on the use and efficacy of biomaterials (BMs) and drug-coated balloons (DCBs). These BMs included hydrogels, collagen scaffolds, and nanoparticles.
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