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Erectile Dysfunction Trial Using SELUTION SLR Enrolls First Patient

Article-Erectile Dysfunction Trial Using SELUTION SLR Enrolls First Patient

Image courtesy of Cision PR Newswire MedAlliance_Logo.jpg
The study will examine the safety and efficacy of a sirolimus-eluting balloon for the treatment of distal internal pudendal-penile artery stenotic disease and ED.

In 2020, an estimated 300 million men worldwide were reported to be affected by erectile dysfunction (ED). This figure is projected to increase to 322 million by 2025. With nearly 30% of these men between 40 and 70-years old, the most common cause of the issue is vascular disease. Additionally, 70% of physical-related causes are due to reduced blood circulation to the penis. Atherosclerotic occlusive disease of the ilio-pudendal-penile arteries resulting in arterial insufficiency in the penis is reported to affect up to 75% of patients with ED. While PDE5 inhibitors like Viagra and Cialis are the most common treatments for ED, up to 50% of patients experience a suboptimal response to medication. Now, a potential alternative therapy is to treat the pudendal and/or penile arteries via the percutaneous approach, using a coronary metallic stent or a balloon.

In hopes to address the industry gap, the PERFECT-SELUTION FIM (Pelvic Revascularization for Erectile dysfunction-SELUTION First-In-Man) clinical trial, which will treat half of its randomized patient-base with MedAlliance’s SELUTION SLR — a sirolimus-eluting balloon — has announced the enrollment of its first patient, an 82-year-old Taiwanese man. The study involves a total of 54 patients effected by distal internal pudendal-penile artery stenotic disease and ED. The randomized half not utilizing SELUTION SLR will be treated with plain old balloon angioplasty (POBA). The patients will have a follow-up with study investigators at 12-weeks post-procedure.

"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, who has performed pudendal and penile artery angioplasty with conventional devices ( POBA and/or stents) on more than 500 patients with arteriogenic ED and acknowledged that restenosis occurred in more than 30% of treated patients, according to a press release. "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."

The SELUTION SLR involves the formation of spherical micro-reservoirs made from biodegradable polymer intermixed with the antiproliferative drug, sirolimus. The micro-reservoirs provide controlled and sustained drug release for up to 90 days.

The primary endpoint for PERFECT-SELUTION FIM is angiographic binary restenosis (>50% lumen diameter stenosis) defined by computer 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 ED.

SELUTION SLR was awarded CE Mark approval in February 2020 for the treatment of peripheral artery disease and added the treatment of coronary arterial 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, coronary de novo, both below and above the knee, AV fistula, and now [ED],” said Jeffrey B. Jump, chairman and CEO of MedAlliance. “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.”

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