January 28, 2021
PRESTIGE below-the-Knee 12-month study was presented as a Late Breaking Trial at LINC 2021.
The objective of this clinical investigation has been to evaluate 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).
The Primary Patency Rate was 78% and the rate of wound healing was 81%. Freedom from Target Lesion Revascularization (TLR) was exhibited by 93% of patients and 84% demonstrated Amputation Free Survival (AFS). All these figures have been sustained from the six-month data.
PRESTIGE below-the-knee study is a prospective, single-center, physician-initiated clinical study, run at the Singapore General Hospital (SGH) by Associate Professor Tze Tec Chong and Dr. Tjun Yip Tang, who are both Senior Consultants at the Hospital’s Department of Vascular Surgery. Twenty-five patients were enrolled with an average age of 64. 88% had diabetes mellitus and 44% had end stage renal failure. No patients required bailout stenting. Clinical follow-up was at one, three, six and 12 months.
“We have observed minimal slow-flow phenomena and some cases of fast wound healing with SELUTION SLR. It is also easy to track and deliver. We are looking forward to gaining further clinical experience with this device,” commented Prof. Chong.
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). SGH performs over 1,000 interventional procedures a year on patients suffering from CLI.
“We are very pleased with the one-year BTK results in this very difficult patient population”, added MedAlliance Chairman and CEO Jeffrey B. Jump. “This complements the excellent results we have seen in SFA and coronary patients”.
In February 2020 MedAlliance received CE Mark approval for SELUTION SLR in the treatment of peripheral artery disease. Both the STEP Pedal Arch study and SUCCESS PTA, a large post marketing clinical study in PAD, will commence enrolment soon. In the US, SELUTION SLR has received US Food and Drug Administration (FDA) Breakthrough Device Designation Status for a DEB in the treatment of peripheral below-the-knee lesions.
SELUTION SLR’s technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained release of the drug. Extended release of sirolimus from stents has been proven highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via an angioplasty balloon.
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.