18-month results from the PRESTIGE* Below-the-Knee (BTK) study have been presented as a Late Breaking Clinical Trial at VIVA21. 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).
Freedom from Target Lesion Revascularization (TLR) was exhibited by 88% of patients and 79% demonstrated Amputation Free Survival (AFS). The rate of wound healing was 79% and 79% of the patients improved their Rutherford score by at least one category. The 18-month results have been sustained from the six-month and twelve-month data.
PRESTIGE is a prospective, single-center, physician-initiated clinical study, run at the Singapore General Hospital (SGH) by Associate Professors Chong Tze Tec and Tang Tjun Yip, Head & Senior Consultant and Senior Consultant respectively 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, 12 and 18 months.
“We have observed minimal slow-flow phenomena, seen with other paclitaxel drug-eluting balloons. We have observed several cases of fast wound healing with SELUTION SLR. It is 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) who may benefit from this technology”, commented Prof. Tang. SGH performs over 1,000 interventional procedures a year on patients suffering from CLI.
“We are very pleased with the 18-month 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, AVF and coronary patients”.
SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary arterial disease in May 2020. The US FDA has awarded SELUTION SLR with four breakthrough designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee and AV-Fistula indications.
In August 2021, the first of over 3,000 patients was enrolled in a ground-breaking coronary randomized controlled study comparing SELUTION SLR with a limus drug-eluting stent [DES]. This is the largest DEB study ever initiated and has the potential to change medical practice.
MedAlliance’s DEB 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 for up to 90 days1. 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.