MedAlliance’s partner in Japan, MDK Medical, has enrolled the first patient 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) earlier this month.
The study involves up to 132 patients across a number of 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, multicentre, open, single-arm clinical investigation. Its primary endpoint will be the primary patency rate at twelve months. Secondary endpoints will 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 US$100M in revenue”, commented MedAlliance chairman and CEO Jeffrey B Jump.
In February 2019, MedAlliance became the first DEB company in the world to receive Breakthrough Device Designation status for a sirolimus DEB from the US Food and Drug Administration (FDA). SELUTION SLR has now achieved three separate FDA Breakthrough Device Designations: for the treatment of AV-Fistula; coronary in-stent restenosis and peripheral below-the-knee lesions. The company announced the enrolment of the first patient in its FDA IDE pivotal coronary trial earlier this month.
In February 2020, MedAlliance announced the award of its first CE mark approval: for SELUTION SLR in the treatment of PAD. In May 2020, the company announced the award of its second CE mark: SELUTION SLR 014 PTCA for the treatment of coronary arterial disease (CAD).