MedAlliance has announced completion of patient enrolment in the PRISTINE clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of patients with below-the-knee (BTK) disease. According to a MedAlliance press release, Selution SLR is the first DEB to be awarded Breakthrough Device designation by the US Food and Drug Administration (FDA).
The objective of the prospective PRISTINE trial is to evaluate the safety and efficacy of the Selution SLR sirolimus DEB in the treatment of infra-inguinal occlusive lesions (TASC C and D) in patients with chronic limb-threatening ischaemia in 75 patients over 12 months at Singapore General Hospital in Singapore.
PRISTINE is a follow-up registry to the PRESTIGE trial. The 12-month data from PRESTIGE were presented at LINC 2021 (The Leipzig Interventional Course, 25–29 January, online), showing sustained benefits up to one year. Eighteen-month data is to be presented at VIVA 2021 (Vascular InterVentional Advances; 4–7 October, Las Vegas, USA), where it is anticipated that these benefits will be further sustained. A similar outcome benefit is expected from PRISTINE in a larger real-world population.
“One of the important things to note is that we had few exclusion criteria, unlike many of the randomised controlled trials using drug-coated balloons in the peripheral vasculature, and the data represent real-life lesions that we face every day as vascular specialists in Singapore”, said lead investigator Tjun Yip Tang (Singapore General Hospital, Singapore).
“PRISTINE will offer further insight, leveraging on our initial experience with the PRESTIGE trial, into whether this sirolimus-eluting balloon will become an established device in our angioplasty armamentarium to fight the neointimal hyperplasia effect and restenosis phenomenon that lead to a significant number of clinically driven target lesion revascularisations in the BTK arteries, in this frail and challenging cohort of patients, whose ischaemic foot wounds are difficult to heal.”
In February 2020, MedAlliance received CE mark approval for Selution SLR in the treatment of peripheral arterial disease (PAD) and in May 2020 received CE mark approval for treatment in coronary arterial disease (CAD). MedAlliance has been awarded FDA Breakthrough designation for the Selution SLR for use in BTK and expects to begin the investigation device exemption (IDE) study later this year.