MedAlliance Selution SLR DEB Evaluated for Treating Erectile Dysfunction in Feasibility Study

August 17, 2021—MedAlliance announced enrollment of the first patient in an erectile dysfunction (ED) feasibility study with its Selution SLR sirolimus drug-eluting balloon (DEB).

According to the Switzerland-based company, the aim of the study is to assess the feasibility and safety of angioplasty with a sirolimus-eluting balloon in patients with ED and distal internal pudendal and/or penile artery stenotic disease, using plain old balloon angioplasty as a comparator. A total of 10 patients will be enrolled in the feasibility study. A successful outcome of the study will lead to a larger ED study composed of approximately 50 patients.

The first patient in the study was treated under the direction of the study’s Principal Investigator Professor Giuseppe Sangiorgi, MD, at Tor Vergata University of Rome in Rome, Italy, where he is Professor of Cardiovascular Interventional Pathology.

“We are very excited by the potential outcome of this study,” commented Prof. Sangiorgi in MedAlliance’s press release. “There are a significant proportion of ED patients who don’t respond to conventional drug therapy, and initial studies have suggested that drug-eluting balloons could provide the solution. The balloon used in this study, providing a slow release of sirolimus, could be particularly suitable.”

According to MedAlliance, an estimated 300 million men worldwide were affected by ED in 2020, a figure projected to increase to 322 million by 2025. Approximately 30% of these men were between 40 to 70 years of age. 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. Up to 50% of ED patients experience a suboptimal response when treated with the most-commonly used form of drug treatment, PDE5i—phosphodiesterase-5 inhibitors (eg, Viagra, Cialis).

The company stated that a potential alternative therapy for these patients is to treat the pudendal and/or penile arteries via the percutaneous approach, using a coronary stent or percutaneous transluminal coronary angioplasty balloon.

MedAlliance’s Selution SLR DEB 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. It is available in Europe and all other countries where the CE Mark is recognized. Selution SLR is not currently licensed for the treatment of ED, cautioned the company.