Med Alliance has announced the on-schedule completion of patient enrolment in the first-in-man (FIM) study of Selution, the company’s sirolimus-coated balloon. Fifty patients have been enrolled between 26 October 2016 and 23 May 2017 across four German centres: Franziskus Krankenhaus, Berlin; Evangelisches Krankenhaus Hubertus, Berlin; Vivantes Klinikum Neukölln, Berlin; and Universitäts-Herzzentrum, Bad Krozingen.
Selution contains micro-reservoirs made out of biodegradable polymer intermixed with sirolimus. The micro-reservoirs, which a press release states are unique to the Selution drug-coated balloon (DCB), 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. This study is intended to demonstrate that Selution is the first DCB with sustained release of sirolimus to be effective in the treatment of both superficial femoral artery and popliteal artery lesions.
The objective of the FIM study is to assess the safety and efficacy of Selution in the treatment of lesions of the superficial femoral artery and/or the popliteal arteries, assessed at multiple time points through clinical, duplex ultrasound and/or angiographic assessment (six-month time point only). The Selution FIM study is a prospective, controlled, multi-centre, open, single-arm clinical investigation. The primary endpoint of the study is angiographic late lumen loss at six months. Secondary endpoints include major adverse events, primary patency, and angiographic binary restenosis.
“In pre-clinical studies, this technology has demonstrated sustained sirolimus release for several months. These findings gave us the confidence to initiate the FIM, whose results will permit comparison to previous studies of paclitaxel drug-coated balloons in the superficial femoral artery”, commented principal investigator Thomas Zeller, Universitaets-Herzzentrum, Bad Krozingen, Germany.
“We are very excited to have completed patient enrolment in this important trial”, adds Klaus Brechtel, Franziskus Krankenhaus, Berlin, Germany. “Both I and my co-investigators participating in this study will now be working towards achieving a meaningful result”.
“This FIM will pave the way for studies in other indications, such as below-the-knee (BTK) lesions, where a balloon coated with sirolimus may be safer and more effective than one coated with paclitaxel”, concludes Zeller.