Med Alliance's Selution DCB Demonstrates Safety and Efficacy in Long Lesions

March 6, 2018—Med Alliance announced that findings 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 CRT 2018, the Cardiovascular Research Technologies conference held March 3–6 in Washington, DC.

According to the company, the SELUTION FIM study demonstrated safety and efficacy in a subgroup analysis of patients with long lesions (mean, 112.05 ± 25.31 mm) with similar safety and efficacy as the overall cohort. In this subgroup, median late lumen loss (LLL) was 0.23 mm and the target lesion revascularization (TLR) rate was 0%.

In the overall cohort data of 50 patients enrolled at four centers in Germany, the study's primary endpoint was achieved with a median LLL 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. The TLR rate was 2.3%. There were no incidences of either death or the need for minor and/or major amputations. The overall cohort findings were first presented by Prof. Zeller at LINC 2018, the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany.

Prof. Zeller, who is with Universitaets-Herzzentrum in Bad Krozingen, Germany, commented in the company's announcement, "These results from the SELUTION FIM study are promising. 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."

He continued, "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 early insight that patients with long lesions have similar efficacy when treated with the Selution sirolimus DEB is very encouraging."

As summarized by Med Alliance, the SELUTION FIM study involved 50 patients enrolled across four German centers. Its objective has been 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 (6-month time point only).

It is a prospective, controlled, multicenter, open, single-arm clinical investigation. In addition to the primary endpoint of angiographic LLL at 6 months, secondary endpoints include major adverse events, primary patency, and angiographic binary restenosis. The study will be carried out to 24 months to confirm safety and efficacy, advised the company.