MedAlliance announced today that it closed patient enrollment for its clinical trial of the Selution SLR 018 BLF drug-eluting balloon.
Nyon, Switzerland–based MedAlliance designed its Selution SLR 018 BLF for the treatment of patients with disease below the knee. The company touts Selution SLR as the first device of its kind to receive an “innovative device designation” from the FDA.
Selution SLR includes unique micro-reservoirs made of biodegradable polymer intermixed with sirolimus. The micro-reservoirs provide a controlled and permanent release of the drug for up to 90 days, while MedAlliance’s CAT (cell-adherent technology) allows microdeposits to coat the balloons and adhere to the vessel lumen when delivered through an angioplasty balloon.
The Pristine clinical trial will investigate the safety and efficacy of treatment with the sirolimus-coated balloon in infrainguinal artero-occlusive disease TASC C and D over 12 months in a group of 75 patients from Singapore suffering from chronic ischemia that threatens the lower extremities, according to a news release.
Pristine serves as a follow-up registry for the Prestige trial, which showed sustained benefits for up to one year. MedAlliance said it expects to observe a similar benefit in the Pristine trial from a larger, real-world population.
Selution SLR holds CE mark, having garnered approval in February 2020 for treating peripheral artery disease, then again in May 2020 for coronary artery disease. The company expects to begin an FDA investigational device exemption trial later this year.
“This is an important study for MedAlliance,” MedAlliance president & CEO Jeffrey B. Jump said in the release. “Our innovative technology has demonstrated safety and efficacy in diseases below the knee in highly complex patients, as seen in the Prestige trial. We expect similar observations in the Pristine registry. This is particularly encouraging as, to date, no other BLF has demonstrated efficacy in this complex patient population. ”
