Med Alliance has announced first patient enrolment in the first-in-man study of the Selution novel sirolimus-coated balloon. Patients were enrolled at the Universitaets-Herzzentrum, Bad Krozingen, Germany, and the Franziskus Krankenhaus, Berlin, Germany.
Selution contains micro-reservoirs made out of biodegradable polymer intermixed with sirolimus. The micro-reservoirs, which are unique to the Selution drug-coated balloon, provide controlled and sustained release of the anti-restenotic drug sirolimus, which is expected to provide a therapeutic effect in treating lesions over a prolonged period of time. This -breaking study is intended to demonstrate that Selution is the first drug-coated balloon with sustained release of sirolimus, according to a Med Alliance press release.
“In pre-clinical studies, this technology has demonstrated sustained sirolimus release for several months. These findings gave us the confidence to initiate the first-in-man trial, the results of which will permit comparison with 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 enrolled the first patient in this important trial”, added Ulrich Beschorner, Universitaets-Herzzentrum, Bad Krozingen, Germany. “Both I and my fellow investigators participating in this study are committed to supporting a rapid enrolment process”.
The objective of the study is to assess the safety and efficacy of Selution in the treatment of de novo occluded/stenotic or re-occluded/restenotic lesions of the superficial femoral artery and/or the popliteal arteries, assessed at multiple time points through clinical, ultrasound and/or angiographic assessment. The study will enrol 50 patients in a prospective, controlled, multicentre, 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.
“This 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”, Zeller concluded.
Enrolment in the Selution first-in-man study is scheduled for completion before summer 2017, with primary endpoint results anticipated in late 2017.