A Prospective, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Effectiveness of the Transdermal Compress Device in Participants With Transfemoral Amputations

This study is a prospective, multicenter, single-arm, open-label study in skeletally mature participants with transfemoral limb loss (unilateral or bilateral), without bone or vascular disease who have or are anticipated to have rehabilitation problems with or cannot use a conventional socket prosthesis. Study participants will undergo surgical implantation of the Transdermal Compress device on Study Day 1. Participant progression including clinical assessments and prosthetic use will follow the study rehabilitation protocol. Events of special interest include superficial and deep infection…