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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 ....

National Taiwan University Hospital , T Ai Pei , Switzerland General , United States , United Kingdom , Richard Kenyon , Tzung Dau Wang , Ma Med Alliance , Cath Lab , Cell Adherent Technology , Erectile Dysfunction , Revascularization For , Cardiac Cath Lab , Sept 10 , 022 Prnewswire An 82 Year Old Taiwanese Man Has Become The First Patient To Be Enrolled In Initial Erectile Dysfunction Ed Randomized Clinical Trial Rct Involving Selution Slr , Edalliance 39s Novel Sirolimus Eluting Balloon The Perfect Selution Fim Pelvic Revascularization For Erectile Dysfuction First In Man Study Involvesa Total Of 54 Patients Suffering From Distal Internal Pudendal Penile Artery Stenotic Disease And Ed They Are Being Randomized To Treatment With Either Slr Or Plain Old Angioplasty Poba , Hen Followed Up Fora Period Of 12 Weeks The Primary Efficacy Endpoint Study Is Angiographic Binary Restenosis Gt 50 Lumen Diameter Stenosis Defined By Computer Tomography Ct And Safety Rate Major Adverse Events Quot We Are Excited To Begin This On Sucha Long Suffering Patient Population Hope That Will Give These Patientsa Better Chance Ofa Normal Life , Nd Look Forward To The Results , Uot Said Tzung Dau Wang , Rofessor Of Medicine And Director Cardiac Cath Lab , National Taiwan University Hospital , Ho Has Performed Pudendal And Penile Artery Angioplasty With Conventional Devices Poba Or Stents On More Than 500 Patients Arteriogenic Erectile Dysfunction Acknowledged That Restenosis Occurred In 30 Of Treated Quot We Do Needa State The Art Technology To Break This Barrier Are Pleased Initiate Study First Patient Responded Well Therapy Have Been Very Clinical Results Many Applications Stent , Oronary De Novo , Oth Below And Above The Knee , V Fistula And Now Erectile Dysfunction This Combination Drug Device Technology Seems To Be Very Versatile , Nd We Look Forward To The Results From This Physician Initiated Study ,