FIH Study Begins for Med Alliance's Selution Sirolimus-Coated Balloon

November 10, 2016—Switzerland-based Med Alliance recently announced commencement of patient enrollment in the first-in-human (FIH) study of the Selution sirolimus-coated balloon for the treatment of peripheral artery disease in the superficial femoral artery (SFA) and/or popliteal artery. Patients were enrolled at the Universitäts-Herzzentrum Freiberg-Bad Krozingen in Bad Krozingen, Germany, and the Franziskus Krankenhaus in Berlin, Germany. Enrollment in the Selution FIH study is scheduled for completion before summer 2017, with primary endpoint results anticipated in late 2017. Prof. Thomas Zeller, MD, with the Clinic for Cardiology and Angiology II of Universitäts-Herzzentrum Freiberg-Bad Krozingen, is the study's Principal Investigator.

According to the company, the objective of the FIH study is to assess the safety and efficacy of the Selution device in the treatment of de-novo occluded/stenotic or reoccluded/restenotic lesions of the SFA and/or the popliteal artery, as assessed at multiple time points by clinical evaluation, ultrasonography, and/or angiography. The study will enroll 50 patients in a prospective, controlled, multicenter, open, single-arm clinical investigation. The primary endpoint of the study is angiographic late lumen loss at 6 months. Secondary endpoints include major adverse events, primary patency, and angiographic binary restenosis.

Med Alliance’s Selution device contains microreservoirs made out of biodegradable polymer intermixed with sirolimus. The microreservoirs provide controlled and sustained release of sirolimus for a therapeutic effect in treating lesions over a prolonged period of time. The study intends to demonstrate that Selution is the first drug-coated balloon with sustained release of sirolimus, stated the company.

In Med Alliance’s press release, Prof. Zeller commented, “In preclinical studies, this technology has demonstrated sustained sirolimus release for several months. These findings gave us the confidence to initiate the [first-in-human study], whose results will permit comparison to previous studies of paclitaxel drug-coated balloons in the SFA.” Prof. Zeller continued, “This FIM will pave the way for studies in other indications, such as below-the-knee lesions, where a balloon coated with sirolimus may be safer and more effective than one coated with paclitaxel.”