MedAlliance’s Selution SLR Sustains Safety and Efficacy at 2 Years in First-in-Human Trial
November 5, 2019—MedAlliance SA, a Switzerland-based medical technology company, announced that 2-year data from the first-in-human study of the company’s Selution SLR sirolimus-eluting balloon were presented by Professor Thomas Zeller, MD, the study’s Principal Investigator, at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
The study was composed of 50 patients enrolled at four German centers who were treated with the investigational device in lesions of the superficial femoral artery (SFA) and popliteal artery.
Prof. Zeller, who is from Universitäts-Herzzentrum in Bad Krozingen, Germany, commented in the company’s announcement, “These 2-year results from the Selution SLR first-in-human study are very encouraging. They are the first 2-year data for a balloon eluting either a limus drug or sirolimus and are confirmation that a sustained limus-release eluting balloon is both safe and effective in the treatment of SFA lesions over a prolonged period.”
According to the company, freedom from target lesion revascularization (TLR) was achieved through 2 years in 87.5% of patients, with no primary TLR event observed after month 11. There were no incidences of death or the need for minor and/or major amputations over this period. Improvements in Rutherford classification, ankle-brachial index, and walking ability observed at 1 year were all maintained out to 2 years.
The Selution SLR first-in-human study is a prospective, controlled, multicenter, open, single-arm clinical investigation. The study’s objective was to assess the safety and efficacy of Selution SLR in the treatment of lesions of the SFA and/or the popliteal artery, measured at multiple time points through clinical, duplex ultrasound, and/or angiographic assessment (6-month time point only).
The primary endpoint of the study was angiographic late lumen loss (LLL) at 6 months. Secondary endpoints included major adverse events, primary patency, and angiographic binary restenosis. Primary endpoint data demonstrating LLL of 0.19 mm were first presented by Prof. Zeller at LINC 2018, the Leipzig Interventional Course in Leipzig, Germany.
According to the company, Selution features microreservoirs made from biodegradable polymer mixed with sirolimus to facilitate controlled and sustained release of the antirestenotic drug. MedAlliance’s cell-adherent technology coating enables the microreservoirs to be applied to balloons and adhered to the vessel lumen when delivered via an angioplasty balloon. European CE Mark approval for Selution SLR is anticipated within the next few months, advised MedAlliance.