MedAlliance, with its Japanese partner MDK Medical, has completed enrollment in the clinical study of its novel Sirolimus Drug Eluting Balloon (DEB), SELUTION SLR™, for the treatment of peripheral arterial disease (PAD).
This follows the acceptance of a Clinical Trial Notification (CTN) by Japan’s Pharmaceutical and Medical Device Agency (PMDA) in June 2020.
The study involves 133 patients across 13 centres in Japan. Its objective is to assess the safety and efficacy of SELUTION SLR for the treatment of lesions of superficial femoral arteries and/or popliteal arteries. The study is a prospective, controlled, multi-centre, open, single-arm clinical investigation. Its primary endpoint is the primary patency rate at twelve months. Secondary endpoints include Major Adverse Events/TLR, Primary Patency, and the change of Rutherford classification/ABI/WIQ.
“We are extremely pleased with the regulatory and quality expertise demonstrated by our partner MDK, and particularly proud that Japanese patients can now benefit from our unique technology. This is the first sirolimus drug eluting balloon implanted in Japan, where the current paclitaxel coated balloon market generates more than $100M in revenue per year”, commented MedAlliance Chairman and CEO Jeffrey B. Jump.
SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary arterial disease in May 2020. The US FDA has awarded SELUTION SLR with four breakthrough designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee and AV-Fistula indications.
In August 2021, the first of over 3,000 patients was enrolled in a ground-breaking coronary randomized controlled study comparing SELUTION SLR with a limus drug-eluting stent [DES]. This is the largest DEB study ever initiated and has the potential to change medical practice.
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.