January 10, 2020
Enrollment Completed in PRESTIGE BTK Trial of MedAlliance’s Selution SLR Device
January 10, 2020—MedAlliance announced the completion of patient enrollment in the PRESTIGE below-the-knee clinical trial, which is evaluating the 6-month safety and performance outcomes of the company’s Selution SLR sirolimus-eluting balloon catheter for the treatment of long tibial occlusive lesions (TASC C & D) in patients with critical limb ischemia.
PRESTIGE is a prospective, single-center, physician-initiated clinical study led by Chong Tze Tec, MD, and Tang Tjun Yip, MD, at Singapore General Hospital in Singapore. Investigators have enrolled 22 patients and will conduct clinical follow-up at 1, 3, 6, and 12 months.
In the company’s announcement, Dr. Tec commented, “The initial performance of Selution SLR has been very encouraging. We have observed good blood flow in the amputation segment and some cases of fast wound healing. The device is also easy to track and deliver. We are eagerly awaiting the study’s follow-up data.”
According to MedAlliance, the Selution SLR device, which is specifically designed to treat peripheral artery disease, combines sirolimus and a biodegradable polymer with the company’s MicroReservoir and Cell Adherent Technology (CAT) to offer a sustained therapeutic effect for > 60 days to achieve long-term clinical benefits.
The device’s MicroReservoirs act as miniature drug delivery systems for sustained sirolimus release. CAT provides drug bioavailability and minimal systemic loss allowing for a lower drug dose concentration on the balloon surface (1 μg/mm2). MicroVention’s amphipathic lipid technology binds the microreservoirs to the balloon surface to protect during the insertion and navigation of the balloon. Once the balloon is inflated, CAT ensures the optimal transfer of microreservoirs to the tissue and enhanced cellular uptake of the sirolimus drug, stated MedAlliance.
In November 2019, positive 2-year data from the first-in-human study of Selution SLR 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 involved 50 patients treated with the investigational device in lesions of the superficial femoral artery and popliteal artery.
Last September, MedAlliance announced it was granted FDA Breakthrough Device designation for the Selution SLR by the FDA for the treatment of below-the-knee disease.