GENEVA, Switzerland, Sept. 10, 2022 /PRNewswire/ An 82-year-old Taiwanese man has become the first patient to be enrolled in the initial Erectile Dysfunction (ED) randomized clinical trial
GENEVA, Switzerland, Sept. 10, 2022 /PRNewswire/ An 82-year-old Taiwanese man has become the first patient to be enrolled in the initial Erectile Dysfunction (ED) randomized clinical trial (RCT) involving SELUTION SLR, MedAlliance's novel sirolimus-eluting balloon. The PERFECT-SELUTION FIM (PElvic Revascularization For EreCTile dysfuction-SELUTION First-In-Man) study involves a total of 54 patients suffering from distal internal pudendal-penile artery stenotic disease and ED. They are being randomized to treatment with either SELUTION SLR or plain old balloon angioplasty (POBA), then followed-up for a period of 12 weeks. The primary efficacy endpoint of the study is angiographic binary restenosis (>50% lumen diameter stenosis) defined by computer tomography (CT) and the primary safety endpoint is the rate of major adverse events. "We are excited to begin this study on such a long-suffering patient population. We hope that this study will give these patients a better chan
GENEVA, Switzerland, Sept. 10, 2022 /PRNewswire/ An 82-year-old Taiwanese man has become the first patient to be enrolled in the initial Erectile Dysfunction (ED) randomized clinical trial (RCT) involving SELUTION SLR, MedAlliance's novel sirolimus-eluting balloon. The PERFECT-SELUTION FIM (PElvic Revascularization For EreCTile dysfuction-SELUTION First-In-Man) study involves a total of 54 patients suffering from distal internal pudendal-penile artery stenotic disease and ED. They are being randomized to treatment with either SELUTION SLR or plain old balloon angioplasty (POBA), then followed-up for a period of 12 weeks. The primary efficacy endpoint of the study is angiographic binary restenosis (>50% lumen diameter stenosis) defined by computer tomography (CT) and the primary safety endpoint is the rate of major adverse events. "We are excited to begin this study on such a long-suffering patient population. We hope that this study will give these patients a better chan