MedAlliance today announced that the first patient has been enrolled in a trial of its Selution SLR sirolimus-eluting balloon.
Last month, the company received an Investigational Device Exemption (IDE) from the FDA for the Selution SLR drug-eluting balloon, which it designed to provide controlled and sustained release of drug, similar to an eluting stent. of medicine. The FDA IDE BTK (below the knee) clinical trial Selution4BTK follows this IDE. Selution SLR received FDA Breakthrough Device designation in 2019.
Selution SLR (sustained limus release) from MedAlliance, based in Geneva, Switzerland, features unique micro-reservoirs made of biodegradable polymer blended with sirolimus. The micro-reservoirs provide controlled, sustained drug release for up to 90 days, while MedAlliance’s cell-adherent technology (CAT) allows the micro-deposits to coat the balloons and adhere to the vessel lumen as they are administered through an angioplasty balloon.
According to a press release, the trial aims to demonstrate superior efficacy and equivalent safety for Selution SLR compared to single (uncoated) balloon angioplasty (POBA) in the treatment of BTK arteries in patients with chronic limb threatening ischemia (CLTI). The prospective, multicenter, single-blind study will randomize 377 subjects 1:1 to Selution SLR or control.
Patients are being recruited from about 40 sites in the United States, Europe and Asia for the study, according to MedAlliance, the first of its kind where patients with real-world critical limb ischemia (CLI) can be enrolled.
“I am very proud of the MedAlliance team who were able to launch this study so quickly and enrolled the first patient only a week after receiving IDE approval,” said MedAlliance President and CEO Jeffrey B. Jump, in the press release. “This is a great achievement and a major milestone for MedAlliance.”
Selution SLR was the first drug-eluting balloon (DEB) to earn Breakthrough Device Designation from the FDA, first in March 2019 and then in September 2019, for below the knee (BTK) indications in arterial disease device (PAD), MedAlliance said.
The drug-eluting balloon currently has CE Mark approval for the treatment of PAD and its four breakthrough device designations by the FDA cover the treatment of atherosclerotic lesions in the innate coronary arteries, in-stent coronary restenosis, peripheral diseases below the knee and indications of arteriovenous fistula.