Geneva, Switzerland, September 10, 2022 /PRNewswire/ — An 82-year-old Taiwanese man becomes the first patient enrolled in the first ever erectile dysfunction (ED) randomized clinical trial (RCT) involving SELUTION SLR™, MedAlliance’s new sirolimus-releasing balloon.
FIM Perfect Selection (PHYSICAL EDUCATION Rivico rhemostasis debt Also me again Connecticut The ile dysfunction-SELUTION First-In-Man study will include a total of 54 patients with stenosis of the distal penile internal pudendal artery and erectile dysfunction.
They will be randomly assigned to treatment with their SELUTION SLR or simple balloon angioplasty (POBA) and will then be followed for 12 weeks. The primary efficacy endpoint of this study was angiographic binary restenosis (>stenosis of 50% lumen diameter) 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 gives these patients a better chance to lead normal lives and we look forward to the results.” increase.” tsundu oneProfessor of Medicine and Director of Cardiology cath lab National Taiwan University Hospital, More than 500 patients with atherogenic erectile dysfunction underwent penile and pudendal artery angioplasty with conventional devices (POBA and/or stents), and restenosis occurred in more than 30% of treated patients. “We need cutting-edge technology to break this barrier.
“We are very pleased with the clinical results in many applications of this technology: in-stent restenosis, de novo coronary, 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 affects the lives of hundreds of millions of people.” Jeffrey B. Skip President and CEO of Med Alliance.
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 erectile dysfunction in 2020, and this number is projected to rise to 322 million by 2025. Almost 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 erectile dysfunction are due to poor blood circulation in the penis. PDE5 inhibitors (Viagra, Cialis, etc.) are the most widely used drug treatments for erectile dysfunction, but up to 50% of treated patients experience suboptimal responses. A possible alternative therapy for these patients is the use of stents or coronary metal balloons to treat the pubic and/or penile arteries through a percutaneous approach. Atherosclerotic obstructive disease of the lipoidemia artery leading to penile arterial insufficiency has been reported to affect up to 75% of patients with erectile dysfunction.
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 granted SELUTION SLR 4 Historic Designations. in-stent coronary restenosis; Peripheral indications below the knee and AV fistula.
of August 2021the first of more than 3,000 patients to be enrolled in a landmark randomized controlled coronary study comparing SELUTION SLR with Limus drug-eluting stents [DES]This is the largest DEB study ever started and has the potential to change medical practice.
MedAlliance’s DEB technology includes a patented MicroReservoir made of a biodegradable polymer mixed with the anti-restenotic drug sirolimus. These microreservoirs provide a controlled and sustained release of the drug for up to 90 days.1Sustained-release sirolimus from stents has been shown to be highly effective in both the coronary and peripheral vasculature. Unique to MedAlliance, its CAT™ (Cell Adherent Technology) allows the MicroReservoir to be coated onto the balloon and adhere to the lumen of the vessel when delivered via an angioplasty balloon.
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About the Media Alliance
MedAlliance is a private medical technology company. Based in Nyon, Swisswith office Germany, SingaporeUK and United States of America MedAlliance specializes in the development of innovative technologies and the commercialization of combination products of advanced drug devices for the treatment of coronary and peripheral artery disease. For more information, visit www.medalliance.com.