MedAlliance announced today that it enrolled the first patient in a trial for its drug-eluting ballon in treating erectile dysfunction.
Geneva, Switzerland-based MedAlliance said an 82-year-old Taiwanese man enrolled in the initial trial. It will evaluate the Selution SLR sirolimus-eluting balloon for the treatment of erectile dysfunction (ED).
The Perfect-Selution FIM study includes 54 patients. The participants suffer from distal internal pudendal-penile artery stenotic disease and ED. They are being randomized to either Selution SLR treatment or plain old balloon angioplasty. There will be a follow-up period of 12 weeks.
MedAlliance said the primary efficacy endpoint is angiographic binary restenosis defined by CT. 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 chance of a normal life, and look forward to the results,” said Tzung-Dau Wang, professor of medicine and director of Cardiac Cath Lab, National Taiwan University Hospital. “We do need state-of-the-art technology to break this barrier. We are pleased to initiate this study: the first patient has responded well to this therapy.”
The study comes on the heels of a feasibility study conducted in Europe last year. That study involved 10 patients with ED.
“We have been very pleased with the clinical results of this technology in many applications: in-stent restenosis, coronary de novo, both below and above the knee, AV fistula and now erectile dysfunction,” MedAlliance Chair and CEO Jeffrey B. Jump said. “This combination drug-device technology seems to be very versatile, and we look forward to the results from this physician-initiated study, as this is clearly an unmet need touching the lives of hundreds of millions of people.”