MedAlliance’s Selution SLR Continues to Be Evaluated to Treat BTK Disease in PRISTINE Registry

August 12, 2021—MedAlliance, which is headquartered in Switzerland, announced completion of patient enrollment in the PRISTINE clinical trial with the company’s Selution SLR 018 sirolimus drug-eluting balloon (DEB) with sustained limus release for the treatment of patients with below-the-knee (BTK) disease. In October 2020, the company announced commencement of enrollment in PRISTINE.

PRISTINE is a prospective registry with the objective to evaluate the safety and efficacy of the Selution SLR DEB in the treatment of infrainguinal occlusive lesions (TASC C and D) in patients with chronic limb threatening ischemia in 75 patients during 12 months at Singapore General Hospital.

According to the company, PRISTINE is a follow up registry to the PRESTIGE trial and is expected to show a similar outcome benefit in a larger real-world population. PRESTIGE completed enrollment in January 2020.

The 12-month data from the PRESTIGE BTK study were presented as a late-breaking trial at LINC 2021, the Leipzig Interventional Course held virtually January 25-29. The PRESTIGE data showed benefits up to 1 year with the device. These benefits are anticipated to be sustained in the 18-month data that will be presented at VIVA 2021, the Vascular Interventional Advances conference to be held in October 4-7 in Las Vegas, Nevada, stated the company.

Associate Professor Tjun Yip Tang, MD, lead investigator of PRISTINE and senior consultant, Department of Vascular Surgery, at Singapore General Hospital in Singapore, commented in the MedAlliance press release, “One of the important things to note is that we had few exclusion criteria, unlike many of the randomized clinical trials using drug-coated balloons in the peripheral vasculature, and the data represent real life lesions that we face every day as a vascular specialist in Singapore.”

Professor Tang continued, “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 revascularizations in the BTK arteries, in this frail and challenging cohort of patients, whose ischemic foot wounds are difficult to heal.”

In February 2020, MedAlliance received European CE Mark approval for Selution SLR in the treatment of peripheral artery disease and CE Mark approval for treating coronary artery disease in May 2020. In the United States, the company announced in September 2019 that the FDA granted Breakthrough Device designation for the Selution SLR for use in BTK. MedAlliance expects to begin its United States investigational device exemption study of the device later in 2021, advised the company.