Las Vegas, November 6, 2019 – Two-year data from the First-in-Human study of SELUTON SLR™, MedAlliance’s novel sirolimus-eluting balloon, was presented November 5th 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”.
SELUTION’s technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These provide controlled and sustained release of sirolimus. To date, extended release of sirolimus has only been demonstrated highly efficacious when delivered from stents. MedAlliance’s proprietary CAT (Cell Adherent Technology) coating enables the micro-reservoirs to be applied to balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.
Founded in 2008, MedAlliance is a Swiss privately-owned medical technology company, with R&D facilities in Irvine, California and Singapore. Its team of experienced professionals has a recognized track record of success in the conception, development and commercialization of drug-eluting stents, balloons, polymers and drugs, and is focused on patient benefit. The company is developing medical products for the treatment of coronary and peripheral artery disease.