Patient Enrolment Completed in MedAlliance PRESTIGE Below-the-Knee Clinical Trial
10 January 2020 – MedAlliance has announced completion of patient enrolment in the PRESTIGE* Below-the-Knee (BTK) clinical trial. The objective of this clinical investigation is to evaluate the six-month safety and performance outcomes of SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, for the treatment of long tibial occlusive lesions (TASC C & D) in patients with Critical Limb Ischemia (CLI).
PRESTIGE is a prospective, single-center, physician-initiated clinical study, being run at Singapore General Hospital by Dr. Chong Tze Tec and Dr. Tang Tjun Yip. Twenty-two patients have now been enrolled. Clinical follow-up will be at one, three, six and 12 months.
“The initial performance of SELUTION SLR has been very encouraging”, commented Dr. Tec. “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”.
CLI is a severe obstruction of the arteries which markedly reduces blood flow to the extremities. It can progress to the point of severe pain and skin ulcers or sores: CLI often leads to amputation.
Singapore has a high percentage of diabetics in its population and CLI therefore constitutes a major challenge among patients seen with Peripheral Artery Disease (PAD). Singapore General Hospital (SGH) performs over 1000 interventional procedures a year on patients suffering from CLI.
The PRESTIGE study, utilizing a sirolimus eluting balloon, is particularly significant in the wake of current controversy surrounding paclitaxel-coated balloons.
Historically, paclitaxel has been the drug of choice for use in drug-coated balloons (DCBs). SELUTION SLR is the first sirolimus drug-eluting balloon specifically designed to treat PAD. This device uniquely combines the proven safety and efficacy of sirolimus with advanced MicroReservoir and Cell Adherent Technology (CAT™) to offer a sustained therapeutic effect for over 60 days, achieving long-term clinical benefits.
The MicroReservoir combines sirolimus, the proven, safe and effective anti-inflammatory drug, with a biodegradable polymer. Millions of these MicroReservoirs act as miniature drug delivery systems, achieving sustained sirolimus release.
The Cell Adherent Technology (CAT™) achieves an unmatched drug bioavailability and minimal systemic loss allowing for a lower drug dose concentration on the balloon surface (1 μg/mm²). Proprietary amphipathic lipid technology binds micro-reservoirs to the balloon surface to protect during insertion and navigation of the balloon. Once the balloon is inflated, CAT ensures optimal transfer of micro-reservoirs to the tissue and enhanced cellular uptake of the sirolimus drug.
SELUTION SLR is using the latest generation of PTA Balloons, offering a broad portfolio for peripheral indications, best in class deliverability and trackability.
“We are excited at the prospect of demonstrating that our breakthrough technology is effective in below-the-knee lesions, so bringing much-needed relief to a substantial group of patients who might otherwise not be effectively treated”, added MedAlliance Chairman and CEO Jeffrey B. Jump.
MedAlliance was granted breakthrough designation by the FDA on September 20th 2019.
Positive, two-year data from the first-in-human study of SELUTION SLR was presented at VIVA 2019 by Principal Investigator Professor Thomas Zeller, M.D., Ph.D., 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.
* Physician initiated, prospective, non-Randomized single-center trial, investigating the safety and Efficacy of the Treatment with the Selution Sirolimus Coated Balloon in TASC C and D Tibial occlusive disease In patients with critical limb Ischemia from SinGaporE.