NYON, Switzerland, Aug. 12, 2021 /PRNewswire/ -- MedAlliance has announced completion of patient enrolment in the PRISTINE clinical trial with SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of patients with Below-the-Knee (BTK) disease. SELUTION SLR is the first DEB to be awarded "Breakthrough Device Designation" by the FDA.
PRISTINE is a Prospective Registry to Investigate the Safety and efficacy of Treatment with SELUTION SLR Sirolimus Drug Coated Balloon in TASC C and D athero-occlusive Infra-iNguinal disease in patients with chronic limb threatening ischemia from SingaporE.
The objective of this trial is to evaluate the safety and efficacy of the SELUTION SLR DEB in the treatment of infra-inguinal occlusive lesions (TASC C and D) in patients with chronic limb threatening ischemia in 75 patients over 12 months at Singapore General Hospital.
PRISTINE is a follow up registry to the PRESTIGE Trial. The 12-month data from PRESTIGE was presented at LINC 2021 in January, showing sustained benefits up to one year. 18-month data is to be presented at VIVA in October this year, 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.
BTK represents the worse part of the spectrum of peripheral artery disease and patients are at an increased risk of limb loss and mortality. One of the cornerstones of BTK treatment is to re-establish blood flow to the foot to promote wound healing. Although percutaneous lower limb angioplasty has become the favored option of revascularization, its Achilles Heel is vessel recoil and restenosis from neointimal hyperplasia.
"One of the important things to note is that we had few exclusion criteria, unlike many of the RCTs 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," said Associate Professor Tjun Yip Tang, Lead Investigator & Senior Consultant, Department of Vascular Surgery, Singapore General Hospital.
"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 below-the-knee arteries, in this frail and challenging cohort of patients, whose ischemic foot wounds are difficult to heal."
"This is an important study for MedAlliance", explained Chairman and CEO Jeffrey B. Jump. "Our breakthrough technology has demonstrated safety and efficacy in below-the-knee diseases in highly complex patients as seen in the PRESTIGE trial. We are expecting similar observations in the PRISTINE registry. This is particularly encouraging, as to date no other DEB has demonstrated effectiveness in this challenging patient population."
In February 2020 MedAlliance received CE Mark approval for SELUTION SLR in the treatment of Peripheral Artery Disease (PAD) and in May 2020 received CE Mark approval for treatment in Coronary Artery Disease (CAD). MedAlliance has been awarded FDA Breakthrough designation for the SELUTION SLR for use in BTK and expect to begin the IDE study later this year. MedAlliance has a robust global clinical trial program to evaluate outcomes in Coronary, SFA, BTK, Dysfunctional AVF and Erectile Dysfunction, across different demographic population groups.
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.
MedAlliance is a privately-owned medical technology company. It is headquartered in Switzerland, with facilities in Irvine, California; Glasgow, UK; and Singapore. MedAlliance specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. For further information visit: www.medalliance.com
1. Drug concentration evident in MicroReservoirs and tissue – Data on file at M.A. Med Alliance SA