In 2020, it is estimated that 300 million men worldwide would be affected by erectile dysfunction (ED). This figure is expected to rise to 322 million by 2025. With almost 30% of these men aged between 40 and 70, the most common cause of the problem is vascular disease. Additionally, 70% of physical causes are due to reduced blood flow to the penis. Atherosclerotic occlusive disease of the ilio-pudendal-penile arteries leading to arterial insufficiency in the penis is thought to affect up to 75% of patients with erectile dysfunction. While PDE5 inhibitors like Viagra and Cialis are the most common treatments for erectile dysfunction, up to 50% of patients show a suboptimal response to the drugs. However, a potential therapeutic alternative consists in treating the pudendal and/or penile arteries percutaneously, using a metallic coronary stent or a balloon.
Hoping to fill the industry gap, the PERFECT-SELUTION FIM (Pelvic Revascularization for Erectile Dysfunction-SELUTION First-In-Man) clinical trial, which will treat half of its patient base randomized to SELUTION MedAlliance’s SLR—a sirolimus-eluting balloon—announced the enrollment of its first patient, an 82-year-old Taiwanese. The study involves a total of 54 patients with distal internal penile-pudendal artery stenosis and erectile dysfunction. The randomized half not using SELUTION SLR will be treated with plain balloon angioplasty (POBA). Patients will follow up with study investigators 12 weeks after the procedure.
“We are excited to begin this study in a population of patients who have suffered for so long. We hope this study will give these patients a better chance at a normal life, and we look forward to the results,” said Tzung- Dau Wang, Professor of Medicine and Director of Cardiac Cath Lab, National Taiwan University Hospital, who has performed pudendal and penile artery angioplasty with conventional devices (POBA and/or stents) on more than 500 patients with erectile dysfunction arteriogenic and acknowledged that restenosis occurred in more than 30% of treated patients, according to a press release. “We need advanced technology to break down this barrier. We are delighted to launch this study: the first patient responded well to this therapy.
The SELUTION SLR involves the formation of spherical micro-reservoirs made from biodegradable polymer mixed with the anti-proliferative drug, sirolimus. The micro-reservoirs allow controlled and sustained drug release for up to 90 days.
The primary endpoint of PERFECT-SELUTION FIM is angiographic binary restenosis (>50% lumen diameter stenosis) defined by computed tomography. Additionally, the primary safety endpoint is the rate of major adverse events. This study follows a successful feasibility study that was conducted in Europe in August 2021 and enrolled 10 patients with erectile dysfunction.
SELUTION SLR obtained CE Mark approval in February 2020 for the treatment of peripheral arterial disease and added the treatment of coronary artery disease in May of the same year.
“We have been very pleased with the clinical results of this technology in many applications: in-stent restenosis, de novo coronary, both below and above the knee, AV fistula, and now [ED]said Jeffrey B. Jump, president and CEO of MedAlliance. “This combination drug-device technology appears to be very versatile, and we eagerly await the results of this physician-initiated study, as this is clearly an unmet need affecting the lives of hundreds of millions of people.”