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
Geneva [Switzerland], August 24 (ANI/PRNewswire): The first US patient has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) clinical trial evaluating SELUTION SLR, MedAlliance s novel sirolimus-eluting balloon
GENEVA, Switzerland, Aug. 24, 2022 /PRNewswire/ The first US patient has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) clinical trial evaluating SELUTION SLR, MedAlliance's novel sirolimus-eluting balloon. This milestone follows Investigational Device Exemption (IDE) approval in the US in May 2022, with enrollment of the first patient occurring in Germany one week after approval. "We are very excited to finally have drug-eluting technology in the US to treat this difficult patient population," commented the trial's Principal Investigator (PI) Dr. Ehrin Armstrong. "We are encouraged by the positive early outcomes with this novel SELUTION SLR Sirolimus Drug Eluting Balloon (DEB) in Europe and Asia. We hope this FDA IDE trial will demonstrate significant benefit for patients who currently have limited treatment options." The aim of the SELUTION4BTK clinical trial is to demonstrate the superior efficacy and equivalent safety of SELUTION SLR compared
GENEVA, Switzerland, Aug. 24, 2022 /PRNewswire/ The first US patient has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) clinical trial evaluating SELUTION SLR, MedAlliance's novel