July 22, 2020
First Patient Enrolled in Japanese Study of MedAlliance's Selution SLR Sirolimus-Eluting Balloon for PAD
July 22, 2020—MedAlliance announced that its partner in Japan, MDK Medical, has enrolled the first patient in the clinical study of the MedAlliance Selution SLR sirolimus-eluting balloon for the treatment of peripheral artery disease (PAD). Earlier this month, a clinical trial notification was approved by Japan’s Pharmaceutical and Medical Device Agency.
According to the company, the study will enroll up to 132 patients across multiple centers in Japan. The study's objective is to assess the safety and efficacy of Selution SLR for the treatment of lesions of the superficial femoral and/or popliteal arteries.
The study is a prospective, controlled, multicenter, open, single-arm clinical investigation. The primary endpoint is the primary patency rate at 12 months. Secondary endpoints include major adverse events/target lesion revascularization; primary patency; and the change in Rutherford classification, ankle-brachial index, and Walking Impairment Questionnaire.
In February 2020, MedAlliance announced European CE Mark approval for the Selution SLR sirolimus-eluting balloon for the treatment of PAD.