The Selution SLR™ drug-eluting Balloon System for the Treatment of Symptomatic Femoropopliteal Lesions

Böhme, Tanja; Noory, Elias; Beschorner, Ulrich; Macharzina, Roland; Zeller, Thomas

doi:10.2217/fca-2020-0085

Cited by 15 publications

(26 citation statements)

References 59 publications

(50 reference statements)

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“…Primary patency rate as assessed by Duplex ultrasound was 88.4% and freedom from restenosis was 91.2%. 12- and 24- month data (Böhme et al 2021 ) also demonstrated sustained improvement in 1 or more categories on the Rutherford Classification from baseline in 78% and 84% of patients at 12- and 24-months respectively and 85% freedom from TLR at 12-month post procedure. There were no incidence of major LEA or death at 24-months, although the patient cohort comprised of only claudicants (Böhme et al 2021 ).…”

Section: Present Evidence For Use Of Sirolimus Devicesmentioning

confidence: 90%

“…New DCBs on the approval pathway mainly feature this new class of antirestenotic issues. At present, only the MagicTouch™ and the Selution SLR™ DCB have received approval for commercial distribution in Europe and granted FDA approval as a breakthrough device for treatment of lower limb PAD (Böhme et al 2021 ). Reimbursement for its use have thus far been variable.…”

Section: Discussionmentioning

confidence: 99%

“…Extensive preclinical testing has been performed on the Selution SLR™ SCB prior to its usage in humans, including assessment of its dimensional and functional attributes, drug and coating characterization, biological evaluation, pharmacokinetics and histological safety, sterilization, packaging integrity as well as stability (Böhme et al 2021 ). In vivo animal studies were conducted in rabbit iliac arteries to assess pharmacokinetics and histological safety of up to 6 months and found the device to perform as intended with no complication such as distal emboli or infarct involving the micro-reservoirs of sirolimus used (Böhme et al 2021 ). The approximate half-life of sirolimus was approximately 90 days in comparison with days to weeks for paclitaxel (Katsanos et al 2018 ), conferring it the theoretical benefit of longer therapeutic effect.…”

Section: Present Evidence For Use Of Sirolimus Devicesmentioning

confidence: 99%

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Utility of sirolimus coated balloons in the peripheral vasculature – a review of the current literature

et al. 2022

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Sirolimus-coated balloons (SCB) have demonstrated much promise as an alternative drug eluting device to the existing paclitaxel coated balloon platforms for the treatment of peripheral arterial disease (PAD). They have been well tested pre-clinically and have demonstrated anti-restenotic effects as well as clinical safety in its use for treatment of coronary artery disease. The existing approved SCBs have thus far demonstrated good short-term patency (12-months) and did not exhibit any major adverse events or device related shortcomings in its use for treatment of PAD. There are several studies ongoing which aim to further investigate the efficacy of existing SCBs and establish a direct comparison of its outcomes compared with plain balloon angioplasty. Also, SCB utility to salvage failing arteriovenous fistulas for haemodialysis patients has also been explored. We review the current progress made in the establishment of SCB in the treatment of PAD as well as highlight ongoing studies investigating the role of SCB in various settings.

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Section: Present Evidence For Use Of Sirolimus Devicesmentioning

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Present Evidence For Use Of Sirolimus Devicesmentioning

confidence: 99%

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Utility of sirolimus coated balloons in the peripheral vasculature – a review of the current literature

et al. 2022

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“…The primary outcome of late lumen loss at six months was significantly lower than the optimal performance outcome value of POBA. Six-month primary patency was 88.4% [ 32 , 33 ].…”

Section: Discussionmentioning

confidence: 99%

Head-to-head comparison of sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery: study protocol for the randomized controlled SIRONA trial

Teichgräber

Ingwersen

Zeller

et al. 2021

Trials

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Background Endovascular revascularization has established as the first-line therapy of femoropopliteal artery disease. Paclitaxel-coated balloon angioplasty proved to be superior to plain old balloon angioplasty (POBA) regarding prevention of restenosis and need for recurrent revascularization. Over the past years, paclitaxel was the only active drug to inhibit neointimal proliferation which could be processed to an appropriate balloon coating. The purpose of this study is to assess whether efficacy and safety of sirolimus-coated balloon angioplasty is noninferior to paclitaxel-coated balloon angioplasty. Methods This randomized controlled, single-blinded, multicentre, investigator-initiated noninferiority trial aims to enrol a total of 478 participants with symptomatic femoropopliteal artery disease of Rutherford category 2 to 4 due to de novo stenosis or restenosis. After pre-dilation, participants will be allocated in a 1:1 ratio to either sirolimus- or paclitaxel-coated balloon angioplasty. Post-dilation with the drug-coated balloon (DCB) used or standard balloon is mandatory in case ≥ 50%, and optional in case of ≥ 30% residual diameter stenosis. Bailout stenting with bare-metal nitinol stents should be conducted in case of flow-limiting dissection. Primary noninferiority endpoints are primary patency and the composite of all-cause mortality, major target limb amputation, and clinically driven target lesion revascularization at 12 months. Secondary outcomes are clinical and hemodynamic improvement, change in health-related quality of life, and safety throughout 60 months. Discussion Although concerns about long-term safety of paclitaxel-coated devices were not confirmed by recent patient-level data analyses, conflicting evidence contributed to a loss of confidence among patients and physicians. Therefore, sirolimus, known for a broader therapeutic range than paclitaxel, may serve as a welcome alternative. This will be justified if noninferiority of sirolimus-coated balloon angioplasty against the current standard of paclitaxel-coated balloon angioplasty can be demonstrated. Trial registration ClinicalTrials.govNCT04475783. Registered on 17 July 2020 EUDAMED No. CIV-20-11-035172, DRKS00022452

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“…With its long and successful history in coronary drug-eluting stents (DES), sirolimus has attracted the attention of researchers investigating new DCB technologies. Sirolimus-coated balloons have so far shown promising results in inhibition of restenosis after percutaneous coronary interventions (PCIs) in a small number of patients included in clinical studies [4][5][6][7][8]. Furthermore, a wide range of other drugs with potential antiproliferative, anti-inflammatory, or antithrombotic actions might be candidates for balloon coating.…”

Section: Introductionmentioning

confidence: 99%

Drug-Coated Balloons: Drugs Beyond Paclitaxel?

Haase¹,

Speck²,

Bienek³

et al. 2022

Front. Biosci. (Landmark Ed)

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Background: Although controversially discussed, paclitaxel is the only clinically proven drug that inhibits restenosis when released from drug-coated balloons (DCBs). Limus drugs are currently being explored as alternatives. The aim of the preclinical studies was to investigate drug candidates beyond paclitaxel considered for balloon coating. Methods: Drugs were tested with respect to dissolution in organic solvents, coating on balloons, and drug transfer to the vessel wall. Inhibition of neointimal proliferation was tested in the porcine model of coronary in-stent stenosis. Intravascular drug treatment was achieved by DCBs at the time of stent implantation. Results: Coating had to be adjusted for each drug. Doses on the balloons ranged from 1.0 to 8.6 µg/mm 2 balloon surface. Satisfactory amounts of drug ranging from 5% to 29% of initial doses were transferred into the vessel wall. Angiographic parameters such as late lumen loss (LLL) at 4 weeks did not show reduction of in-stent neointimal proliferation by treatment with arsenic trioxide (0.87 ± 0.44 mm), betamethasone dipropionate (1.00 ± 0.54 mm), bortezomib (1.74 ± 0.46 mm), green tea extract (1.24 ± 0.51 mm), fantolon, an epothilone (0.86 ± 0.61 mm), methotrexate (1.09 ± 0.72 mm), and thalidomide (1.59 ± 0.55 mm) compared to treatment with uncoated balloons (1.07 ± 0.60 mm), while coatings with paclitaxel reliably reduced in-stent stenosis (LLL = 0.36 ± 0.25 mm). Conclusions: Despite the proven antiproliferative and/or anti-inflammatory effect of the drugs, none of the coatings significantly reduced LLL compared to uncoated balloons and thus, based on the results presented here, none of the tested coatings may be considered a substitute for the paclitaxel-based coatings currently in clinical use.

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The Selution SLR™ drug-eluting Balloon System for the Treatment of Symptomatic Femoropopliteal Lesions

Cited by 15 publications

References 59 publications

Utility of sirolimus coated balloons in the peripheral vasculature – a review of the current literature

Utility of sirolimus coated balloons in the peripheral vasculature – a review of the current literature

Head-to-head comparison of sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery: study protocol for the randomized controlled SIRONA trial

Drug-Coated Balloons: Drugs Beyond Paclitaxel?

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