Patient enrolment in the PRESTIGE below-the-knee (BTK) clinical trial has been completed. 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 and D) in patients with critical limb ischaemia (CLI).
PRESTIGE is a prospective, single-centre, physician-initiated clinical study, being run at Singapore General Hospital, Singapore, by Chong Tze Tec and 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”, Tec says. “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”.
Singapore has a high percentage of diabetics in its population, and CLI therefore constitutes a major challenge among patients seen with peripheral arterial disease (PAD). Singapore General Hospital (SGH) performs over 1,000 interventional procedures a year on patients suffering from CLI.
The PRESTIGE study, utilising a sirolimus-eluting balloon, is particularly significant in the wake of current controversy surrounding paclitaxel-coated balloons, a MedAlliance press release states.
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 combines the safety and efficacy of sirolimus with advanced MicroReservoir and cell adherent technology to offer a sustained therapeutic effect for over 60 days, achieving long-term clinical benefits.
The MicroReservoir combines sirolimus with a biodegradable polymer. Millions of these MicroReservoirs act as miniature drug delivery systems, achieving sustained sirolimus release.
The cell adherent technology achieves an unmatched drug bioavailability and minimal systemic loss, allowing for a lower drug dose concentration on the balloon surface (1μg/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, the cell adherent technology ensures transfer of micro-reservoirs to the tissue and cellular uptake of the sirolimus drug.
“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”, adds MedAlliance chair and CEO Jeffrey B Jump.
MedAlliance was granted breakthrough designation by the FDA on 20 September 2019.
Positive, two-year data from the first-in-human study of SELUTION SLR was presented at the 2019 Vascular Interventional Advances conference (VIVA; 4–7 November, Las Vegas, USA) by principal investigator Thomas Zeller (Universitaets-Herzzentrum, Bad Krozingen, Germany). The study involved 50 patients treated with the investigational device in lesions of the superficial femoral artery and popliteal artery.