Med Alliance's SELUTION FIM Study Achieves Primary Endpoint
January 31, 2018—Med Alliance announced that primary endpoint data from the first-in-man (FIM) study of the company's Selution sirolimus-coated balloon were presented by Principal Investigator Professor Thomas Zeller, MD, at LINC 2018, the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany.
The company advised that these data complete the documentation required to submit the Selution device for European CE Mark approval. The Selution device features microreservoirs made from biodegradable polymer mixed with sirolimus that facilitate controlled and sustained release of the antirestenotic drug.
Med Alliance stated that the SELUTION FIM study is a prospective, controlled, multicenter, open, single-arm clinical investigation. The study's primary endpoint is angiographic late lumen loss at 6 months. Secondary endpoints include major adverse events, primary patency, and angiographic binary restenosis.
The SELUTION FIM study was composed of 50 patients enrolled at four centers in Germany. The study's objective is to assess the safety and efficacy of the Selution device in the treatment of lesions of the superficial femoral artery and/or the popliteal arteries, measured at multiple time points through clinical, duplex ultrasound, and/or angiographic assessment (at 6-month time point only).
According to the company, the SELUTION FIM study demonstrated a median late lumen loss of the target lesion of 0.19 mm (-1.16 to 3.07), as measured by quantitative vascular angiography at 6 months after the index procedure, with a target lesion revascularization rate of 2.3%. There were no incidences of either death or the need for minor and/or major amputations.
In the company's press release, Prof. Zeller commented, “These initial results from the SELUTION FIM study are encouraging. The findings confirm the efficacy of the Selution sirolimus-coated technology and they concur with previous paclitaxel drug-coated balloon studies in the superficial femoral artery. The primary endpoint has been achieved, and excellent clinical outcomes have been reported: Rutherford classification, ankle-brachial-index, walking impairment, and quality-of-life assessment have all indicated beneficial patient improvement from this sirolimus technology. The study will be carried out to 24 months to confirm safety and efficacy.” Prof. Zeller is with Universitäts-Herzzentrum in Bad Krozingen, Germany.