First Patient Enrolled in Erectile Dysfunction Prospective Randomized Study with SELUTION SLR™
9 September 2022 – 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 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 erectile dysfunction and acknowledged that restenosis occurred in more than 30% of treated patients. “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”.
“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. 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”, added Jeffrey B. Jump, Chairman and CEO of MedAlliance.
This study follows a successful feasibility study conducted in Europe in August 2021, involving ten patients with ED.
It is estimated that over 300 million men worldwide were affected by ED in 2020, a figure projected to increase to 322 million by 2025. Nearly 30% of these were aged between 40 and 70. The most common cause of ED is vascular disease. 70% of physically-related causes of ED are due to reduced blood circulation to the penis. PDE5 inhibitors (e.g. Viagra, Cialis) are the most commonly used form of drug treatment for ED, but up to 50% of those patients treated experience a suboptimal response. A potential alternative therapy for these patients is to treat the pudendal and/or penile arteries via the percutaneous approach, using a coronary metallic stent or a balloon. 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.
SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary arterial disease in May 2020. The US FDA has awarded SELUTION SLR with four breakthrough designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee and AV-Fistula indications.
In August 2021, the first of over 3,000 patients was enrolled in a ground-breaking coronary randomized controlled study comparing SELUTION SLR with a limus drug-eluting stent [DES]. This is the largest DEB study ever initiated and has the potential to change medical practice.
MedAlliance’s DEB technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days1. Extended release of sirolimus from stents has been proven highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via an angioplasty balloon.