MedAlliance Enrolls First US Patient into its Third FDA IDE Study: SFA SELUTION4SFA
SFA SELUTION4SFA is being conducted in over 30 centers in the US plus an additional 10 centers worldwide. The study will enroll 300 patients, with the aim of demonstrating the superiority of SELUTION SLR over balloon angioplasty (POBA). The primary efficacy endpoint is primary patency of the target lesion at 12 months and the primary safety endpoint is freedom from death at 30 days. Enrollment into the study will be complete by the end of 2023.