MedAlliance announced today that the first patient was enrolled in a trial of its Selution SLR sirolimus-eluting balloon.
Last month, the company received FDA investigational device exemption (IDE) for the Selution SLR drug-eluting balloon, which it designed to provide a controlled sustained drug release, similar to a drug-eluting stent. The FDA IDE BTK (below-the-knee) Selution4BTK clinical trial comes on the heels of that IDE. Selution SLR was granted FDA breakthrough device designation in 2019.
Geneva, Switzerland-based MedAlliance’s Selution SLR (sustained limus release) features 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.
According to a news release, the trial aims to demonstrate superior efficacy and equivalent safety for Selution SLR compared to plain (uncoated) balloon angioplasty (POBA) in the treatment of BTK arteries in chronic limb-threatening ischemia (CLTI) patients. The prospective, multi-center, single-blinded study will randomize 377 subjects 1:1 with either Selution SLR or control.
Patients are being enrolled across approximately 40 sites in the U.S., Europe and Asia for the study MedAlliance says is the first of its kind where real-world critical limb ischemia (CLI) patients can be included.
“I am very proud of the MedAlliance team which has been able to initiate this study so quickly and have the first patient enrolled only a week after receiving IDE approval,” MedAlliance Chair and CEO Jeffrey B. Jump said in the release. “This is a great achievement and a major milestone for MedAlliance.”
Selution SLR was the first drug-eluting balloon (DEB) to garner FDA breakthrough device designation, first in March 2019, then September 2019, for below-the-knee (BTK) indications in peripheral artery disease (PAD), MedAlliance said.
The drug-eluting balloon currently has CE mark approval for treating PAD and its four total FDA breakthrough device designations cover the treatment of atherosclerotic lesions in innate coronary arteries, coronary in-stent restenosis, peripheral diseases below the knee and indications for arteriovenous fistula.