Geneva, Switzerland, September 10, 2022 /PRNewswire/ — An 82-year-old Taiwanese man becomes the first patient to be enrolled in the first erectile dysfunction (ED) randomized clinical trial (RCT) involving SELUTION SLR™, MedAlliance’s new sirolimus-eluting balloon I was.
Perfect Selection FIM (PERivic R.Hemostasis debtAlso eagainCTThe ile dysfuction-SELUTION First-In-Man) study will include a total of 54 patients with distal internal pudendal penile artery stenosis and ED. They will be randomized to treatment with either her SELUTION SLR or plain old balloon angioplasty (POBA) and then followed for 12 weeks. The primary efficacy endpoint of this study was angiographic binary restenosis (>50% lumen diameter stenosis) was defined by computed tomography (CT), and the primary safety endpoint was the incidence of major adverse events.
“We are excited to begin this study in such a long-suffering patient population. We hope this study will give these patients a better chance to lead a normal life and we look forward to the results.” increase.” tsundu oneProfessor of Medicine and Director of Cardiology cath labNational Taiwan University Hospital, Over 500 patients with arterogenic erectile dysfunction underwent pudendal and penile artery angioplasty using conventional devices (POBA and/or stents), and restenosis occurred in over 30% of treated patients “We need cutting-edge technology to break through this barrier.
“We are very pleased with the clinical results in many applications of this technology: in-stent restenosis, coronary de novo, both below and above the knee, AV fistula, and now erectile dysfunction. We look forward to the results of this physician-led study as it is an unmet need that impacts the lives of hundreds of millions of people.” Jeffrey B. JumpChairman and CEO of MedAlliance.
This study follows a successful feasibility study conducted in Europe of August 2021including 10 patients with ED.
It is estimated that more than 300 million men worldwide will be affected by ED in 2020, and this number is projected to increase to 322 million by 2025. Nearly 30% of these men were between the ages of 40 and 70. Vascular disease is the most common cause of ED. 70% of the physical causes of ED are due to poor blood circulation to the penis. PDE5 inhibitors (Viagra, Cialis, etc.) are the most commonly used drug treatments for ED, but up to 50% of treated patients experience suboptimal responses. A potential alternative therapy for these patients is the use of coronary metal stents or balloons to treat the pubic and/or penile arteries via a percutaneous approach. Atherosclerotic obstructive disease of the iliopudendal artery leading to arterial insufficiency into the penis has been reported to affect up to 75% of patients with ED.
SELUTION SLR received CE Mark approval for the treatment of peripheral arterial disease. February 2020 and for the treatment of coronary artery disease May 2020The US FDA has given SELUTION SLR 4 landmark designations. Coronary in-stent restenosis; peripheral below-the-knee and AV-fistula indications.
of August 2021the first of more than 3,000 patients to be enrolled in a landmark coronary randomized controlled study comparing SELUTION SLR with Limus drug-eluting stents [DES]This is the largest DEB study ever initiated and has the potential to change medical practice.
MedAlliance’s DEB technology includes a proprietary MicroReservoir made from a biodegradable polymer blended with the anti-restenotic drug sirolimus. These microreservoirs provide controlled and sustained release of drug for up to 90 days.1The sustained release of sirolimus from stents has proven to be highly effective in both the coronary and peripheral vasculature. Unique to MedAlliance, his CAT™ (Cell Adherent Technology) allows the MicroReservoir to be coated onto the balloon and adhered to the vessel lumen when delivered via an angioplasty balloon.
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About Media Alliance
MedAlliance is a privately held medical technology company. Headquartered in Nyon, Switzerlandwith office Germany, SingaporeUK and united states of americaMedAlliance specializes in developing breakthrough technologies and commercializing advanced drug device combination products for the treatment of coronary and peripheral artery disease. For more information, please visit www.medalliance.com.
1. Obvious drug concentrations in MicroReservoirs and tissues – data archived at MA Med Alliance SA