PCRonline/News/Industry Press Releases
Med Alliance has announced completion on schedule of patient enrolment in the First-in-Man (FIM) study of SELUTION™, a novel sirolimus-coated balloon. 50 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 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 groundbreaking 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.
“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 Professor Thomas Zeller, Universitaets-Herzzentrum, Bad Krozingen, Germany.
