Twelve-month results from the PRESTIGE below-the-knee (BTK) study have been presented as a late-breaking trial at LINC 2021 (25–29 January, virtual). 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 and D) in patients with chronic limb-threatening ischaemia (CLTI).
The primary patency rate was 78% and the rate of wound healing was 81%. Freedom from target lesion revascularisation (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 is a prospective, single-centre, physician-initiated clinical study, run at the Singapore General Hospital (SGH) by Tze Tec Chong and 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. Eighty-eight per cent 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 Chong.
Singapore has a high percentage of diabetics in its population and CLTI therefore constitutes a major challenge among patients seen with peripheral arterial disease (PAD). SGH performs over 1,000 interventional procedures a year on patients suffering from CLTI.
In February 2020 MedAlliance received CE mark approval for SELUTION SLR in the treatment of peripheral arterial 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 drug-eluting balloon (DEB) in the treatment of peripheral below-the-knee lesions.