MedAlliance Begins PERFECT-SELUTION FIM Randomized Trial of Selution SLR Balloon to Treat Erectile Dysfunction

September 9, 2022—MedAlliance announced the commencement of enrollment in PERFECT-SELUTION FIM, a first-in-man randomized controlled trial of pelvic revascularization for erectile dysfunction (ED) using the company’s Selution SLR sirolimus-eluting balloon.

According to the company, the PERFECT-SELUTION FIM study will enroll 54 patients with distal internal pudendal-penile artery stenotic disease and ED. Patients will be randomized to treatment with either the Selution SLR device or plain old balloon angioplasty (POBA), with 12-week follow-up.

The trial’s primary efficacy endpoint is angiographic binary restenosis (≥ 50% lumen diameter stenosis) defined by CT. The primary safety endpoint is the rate of major adverse events.

A Taiwanese man (aged 82 years) was the first patient enrolled in the PERFECT-SELUTION FIM trial.

Tzung-Dau Wang, MD, commented in the company’s press release, “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. We do need a 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.”

Dr. Wang, who is Professor of Medicine and Director of Cardiac Catheterization Lab, National Taiwan University Hospital in Taipei, Taiwan, has performed pudendal and penile artery angioplasty with conventional devices (POBA and/or stents) on > 500 patients with arteriogenic ED and acknowledged that restenosis occurred in > 30% of treated patients, noted the company.

The PERFECT-SELUTION FIM trial was preceded by a successful feasibility study conducted in Europe in August 2021 that enrolled 10 patients with ED.

According to MedAlliance, an estimated 300 million men worldwide were affected by ED in 2020, a figure projected to increase to 322 million by 2025. Approximately 30% of these men were between 40 to 70 years of age. Atherosclerotic occlusive disease of the ilio-pudendal-penile arteries resulting in arterial insufficiency to the penis has been reported to affect up to 75% of patients with ED. Up to 50% of ED patients experience a suboptimal response when treated with the most commonly used form of drug treatment, PDE5i—phosphodiesterase-5 inhibitors (eg, Viagra, Cialis).

The company stated that a potential alternative therapy for these patients is to treat the pudendal and/or penile arteries via the percutaneous approach, using a coronary stent or percutaneous transluminal coronary angioplasty balloon.

MedAlliance’s Selution SLR drug-eluting balloon was awarded CE Mark approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary artery disease in May 2020. It is available in Europe and all other countries where the CE Mark is recognized.

Selution SLR is not currently licensed for the treatment of ED, advised the company.