Men with erectile dysfunction may be able to turn to Medtronic Inc.’s (NYSE:MDT) drug-eluting pudendal stent when drugs fail to help, according to a preliminary study.
The Minneapolis-based medical device giant concluded an initial feasibility study of 30 men, and 30-day results found the drug-eluting stent safe and significantly effective in treating erectile dysfunction.
The study, unveiled at this year’s Vascular Interventional Advances conference, was a hybrid of vascular intervention and sexual health medicine, TheHeart.org reported, a rare meeting for medicine.
"This is a potentially remarkable kind of intervention," Dr. Jason Rogers, who unveiled the study results, told TheHeart.org. "The men who’ve been treated are incredibly excited and enthusiastic. We know that erectile dysfunction has a huge impact on the quality of life."
Rogers added that the benefits go beyond the individuals to their loved ones.
"We have had grateful couples," he said. "The impact has been large."
Medtronic’s launched the trial in 2009 as a first-in-man feasibility study for up to 50 patients with erectile dysfunction who had failed to respond to drug therapies such as Viagra, Cialis or Levitra.
The study implanted stents coated in zotarolimus in the internal pudendal artery, which supplies blood to the penis, to open the vessel and improve blood flow.
Initial findings saw at least 4 points of improvement on the 30-point Index of Erectile Dysfunction scale, and there were no adverse events at 30 days.
"The link between erectile dysfunction and coronary artery disease has been well established," Rogers said in a 2009 press release. "Based on this evidence, we are investigating the use of stents in pelvic arteries to determine whether it may provide a new treatment approach and enable better response to drug therapies."