MedAlliance announced today that it completed patient enrollment for a trial of its Selution SLR sirolimus drug-eluting balloon.
Geneva, Switzerland-based MedAlliance, along with Japanese partner MDK Medical, completed the enrollment following the acceptance of a Clinical Trial Notification (CTN) by the Pharmaceutical Products and Medical Devices Agency (PMDA) of Japan in June 2020.
The study will evaluate the safety and efficacy of Selution SLR for treating superficial or popliteal femoral artery lesions in 133 patients across 13 centers in Japan. The prospective, controlled, multicenter, open-label, single-group clinical investigation holds a main variable of primary patency rate at 12 months, with secondary endpoints including major adverse events/revascularization of the treated lesion (RLT), primary patency and change in the Rutherford/ABI/WIQ classification, according to a news release.
“We are extremely satisfied with the quality and normative experience demonstrated by our partner MDK, and particularly proud that Japanese patients can now benefit from our unique technology,” MedAlliance president & CEO Jeffrey B. Jump said in the release. “This is the first sirolimus drug-eluting balloon implanted in Japan, where the current market of paclitaxel-coated balloons generates revenues of more than $ 100 million per year.”
Selution SLR holds CE mark approval for treating peripheral artery disease (PAD) and has received four FDA breakthrough device designations for treating atherosclerotic lesions in innate coronary arteries, coronary in-stent restenosis, peripheral diseases below the knee and indications for arteriovenous fistula.
The platform 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.
Last month, the company closed enrollment for a clinical trial for the treatment of patients with disease below the knee. Five days after that, MedAlliance enrolled the first patient in an erectile dysfunction (ED) feasibility study using Selution SLR.