First-in-Human Study of Med Alliance's Selution DCB Completes Enrollment

May 30, 2017—Med Alliance Group, Inc., a Switzerland-based company, announced completion of patient enrollment in the first-in-human (FIH) evaluation of the Selution sirolimus-coated balloon in peripheral arteries. The commencement of enrollment in the Selution FIH study was announced by the company in the fall of 2016. The study's Principal Investigator is Prof. Thomas Zeller, MD, of Universitäts-Herzzentrum in Bad Krozingen, Germany.

Between October 26, 2016 and May 23, 2017, 50 patients were enrolled at four German centers: Franziskus Krankenhaus, Berlin; Evangelisches Krankenhaus Hubertus, Berlin; Vivantes Klinikum Neukölln, Berlin; and Universitäts-Herzzentrum, Bad Krozingen.

According to Med Alliance, the Selution FIH study is a prospective, controlled, multicenter, open, single-arm clinical investigation that aims to demonstrate that Selution is the first drug-coated balloon (DCB) with sustained release of sirolimus to be effective in the treatment of both superficial femoral artery and popliteal artery lesions. 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.

The study will assess the safety and efficacy at multiple time points through clinical, duplex ultrasound, and/or angiographic assessment (6-month time point only). Primary endpoint results for the study are anticipated later this year. These will complete the documentation required to submit for European CE Mark approval of the Selution sirolimus-coated balloon, advised Med Alliance.

The company noted that the Selution DCB contains microreservoirs that are composed of biodegradable polymer intermixed with sirolimus. The microreservoirs provide controlled and sustained release of the antirestenotic drug sirolimus, which is expected to provide a therapeutic effect in treating lesions over a prolonged period of time.

In Med Alliance's announcement, 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 FIH study, whose results will permit comparison to previous studies of paclitaxel DCBs in the superficial femoral artery."Prof. Zeller added, “This FIH study 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."