Safety and Efficacy Sustained Over Two Years in SELUTION SLR™ First-in-Human Trial
Las Vegas, 5 November 2019 – Two-year data from the First-in-Human study of SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, was presented today at VIVA 2019 by Principal Investigator Professor Thomas Zeller, Universitaets-Herzzentrum, Bad Krozingen, Germany. The study involved 50 patients treated with the investigational device in lesions of the superficial femoral artery (SFA) and popliteal artery.
Excellent freedom from Target Lesion Revascularization (TLR) was achieved through to two years in 87.5% of patients, with no primary TLR event observed after Month 11. These figures are low for a drug-eluting balloon First-in-Human study over this time period. There were no incidences of death or the need for minor and/or major amputations over this period. Improvements in Rutherford Classification, ABI and walking ability previously observed at one year were all maintained out to two years.
“These two-year results from the SELUTION SLR First-in-Human study are very encouraging”, commented Prof. Zeller. “They are the first two 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”.
The study involved 50 patients enrolled across four German centres. Its objective has been to assess the safety and efficacy of SELUTION SLR in the treatment of lesions of the superficial femoral artery and/or the popliteal arteries, measured at multiple time points through clinical, duplex ultrasound and/or angiographic assessment (six-month time point only). The SELUTION SLR First-In-Human study was a prospective, controlled, multi-centre, open, single-arm clinical investigation. The primary endpoint of the study was angiographic Late Lumen Loss (LLL) at six months. Secondary endpoints included Major Adverse Events, Primary Patency, and angiographic Binary Restenosis. Primary endpoint data, first presented by Prof. Zeller at LINC in January 2018, demonstrated a LLL of 0.19mm.
“We are very encouraged by this positive study, which confirms the role for a sustained limus release eluting balloon in peripheral intervention”, added MedAlliance Chairman and CEO Jeffrey B. Jump. “We anticipate that the award of a CE Mark for SELUTION SLR, expected within the next few months, will further validate the claims of safety and efficacy for our DEB”.