MedAlliance’s SELUTION SLR Japanese Study Completes Enrollment

September 21, 2021—MedAlliance, with its Japanese partner MDK Medical, has completed enrollment in the clinical study of Selution SLR, the company’s sirolimus drug-eluting balloon (DEB) for the treatment of peripheral artery disease (PAD).

In June 2020, the Clinical Trial Notification was accepted by Japan’s Pharmaceutical and Medical Device Agency. The company announced the beginning of enrollment on July 22, 2020.

According to the company, the study’s objective is to assess the safety and efficacy of the Selution SLR DEB for the treatment of lesions of superficial femoral arteries and/or popliteal arteries. The study is a prospective, controlled, multicenter, open, single-arm clinical investigation. The study will enroll 133 patients at 13 centers in Japan.

The primary endpoint of the study is the primary patency rate at 12 months. Secondary endpoints include major adverse vents/target lesion revascularization, primary patency, and the change of Rutherford classification, ankle-brachial index, and Walking Impairment Questionnaire scores.

MedAlliance advised that the Selution SLR DEB was awarded CE Mark approval for the treatment of PAD in February 2020 and for the treatment of coronary artery disease in May 2020. In the United States, the FDA has awarded Breakthrough Device designations for the device for these four indications: treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee; and arteriovenous fistula.

On August 31, 2021, the company announced the beginning of enrollment in the randomized controlled SELUTION DeNovo study of the company’s coronary Selution SLR sirolimus DEB versus a limus drug-eluting stent. The study will be composed of more than 3,300 patients.