Oct. 20 (Bloomberg) -- Men with erectile dysfunction caused by clogged arteries leading to the penis may be helped by Medtronic Inc.’s drug-coated stent, a device more commonly associated with treating heart disease.
The stent is safe and improves erectile function in men who don’t respond to conventional therapy such as Pfizer Inc.’s Viagra, Bayer AG’s Levitra and Eli Lilly & Co.’s Cialis, according to a study released yesterday at the annual meeting for Vascular Interventional Advances in Las Vegas. The clinical trial is the first to test stents for treating impotence in men who don’t respond to drug therapy, researchers said.
The study found 68 percent improvement in erectile function after three months in 30 men with an average age of 60 who were implanted with the stents. Their impotence was caused by narrowed pudendal arteries in the pelvis. There were no issues such as clots or the need for surgery one month after treatment in the study funded by Minneapolis-based Medtronic.
“This isn’t a panacea for erectile dysfunction,” said Jason Rogers, director of interventional cardiology at the University of California Davis Medical Center in Sacramento. “We set out to show this could be done and it didn’t hurt people. It was a first-in-man trial and the fact that it was feasible and improved blood flow is amazing. This is the birth of a whole new approach to erectile dysfunction.”
Thirty million men in the U.S. and more than 300 million worldwide suffer from erectile dysfunction. The majority of the cases stem from vascular problems, including insufficient blood from the arteries, studies show.
Mesh stents made by Medtronic and rivals including Natick, Massachusetts-based Boston Scientific Corp. are routinely used to prop open diseased arteries to the heart. As many as 70 percent of men with heart disease also report problems achieving an erection, Rogers said.
While drugs such as Viagra, Levitra and Cialis help many men, as much as half eventually stop taking the medicine because of inadequate response or side effects, Rogers said. The few alternatives include penile injections and prostheses.
Viagra generated $1.9 billion for Pfizer in 2010, while Lilly’s Cialis had $1.7 billion in sales and Levitra produced revenue of $569 million for Bayer, according to Bloomberg data.
Some doctors tested balloon angioplasty to clear clogged arteries in the pelvis in the 1980s to treat impotence, though their results were never systematically studied or published, Rogers said. Little progress was made in the following three decades, he said in a telephone interview.
In the study released at the medical meeting, a sexual encounter profile showed a significant improvement in intercourse, while ultrasound exams found increased blood flow to the penis. The men reported a 10 point improvement on a 30 point international index of erectile function, the main test used to evaluate new treatments.
The researchers didn’t include information from eight patients. Three weren’t available three months after the procedure and five had the stents implanted outside the main arteries targeted in the trial.
While the results are promising, more work must be done to confirm the safety and benefit of the approach, Rogers said. Medtronic is working on a second study, called Impasse, involving 350 men.
“Achieving a good erection requires a variety of vascular components to work well, including a good flow of blood to the penis through the arteries,” Rogers said. While drugs like Viagra relax the spongy tissue to allow the blood to enter, “if you don’t have good inflow into the penis, it doesn’t matter how much that tissue relaxes, you don’t have a good erection,” he said.
--Editors: Andrew Pollack, Donna Alvarado
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