New Device Helps Treat Erectile Dysfunction

A new kind of stent offers an alternative to pharmaceuticals for men with erectile dysfunction, an Oct. 19 Reuters article reported.

A stent is a tube made of wire mesh that can be surgically placed in blocked or narrowed blood vessels to improve circulation. Stents are typically used to address issues involving vessels to the heart, but Medtronic has developed a stent that can be positioned in an artery that supplies the penis with blood.

A study by Medtronic involving 30 men with an average age of 60 resulted in significant improvement for about 20 of the participants. There were no side effects within three months of the stents being surgically implanted in the men's internal pudenda artery, though long-term issues remain a possibility.

Drugs like Viagra work through vasodilatation, meaning they allow blood vessels to dilate and allow more blood flow. The vascular tissue of the penis responds to such drugs, allowing the tissue to become engorged with blood and resulting in an erection.

But not all men can take such drugs. Some heart patients must avoid vasodilators. Also, while the vascular tissue of the penis responds to drugs like Viagra and Cialis, if the pudenda artery is clogged or narrow, the blood is not available to the vascular tissue.

The men in the study had suffered narrowing of the pudenda artery, such that the vascular tissue did not have enough blood to allow them to get or maintain an erection. The stent's job was to hold the artery open and allow blood to get to the vascular tissue.

There is an enormous potential market for products that address erectile dysfunction, or ED.

"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," Bloomberg Businessweek reported on Oct. 20.

The study showed "a sexual encounter profile showed a significant improvement in intercourse, while ultrasound exams found increased blood flow to the penis," the Bloomberg Businessweek article added. "The men reported a 10 point improvement on a 30 point international index of erectile function, the main test used to evaluate new treatments."

While some companies have produced pills like Cialis and Levitra, one condom manufacturer created a new product that combines safer sex with the vasodilatation effect of drugs like Viagra.

"We set out to show this could be done and it didn't hurt people," said researcher Jason Rogers of the University of California Davis Medical Center. "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," Rogers added.

The new condom--the CSD500, made by Futura Medical and marketed under the Durex brand--is lubricated with a special gel that allows the active ingredient to be absorbed through the skin, allowing men who have difficulty maintaining erections while using condoms to overcome that hurdle. However, there is a catch: Men who suffer from an inability to get an erection in the first place would still need to use something like Viagra or Cialis before putting the condom on.

The new condom was cleared for use in Europe and some non-European markets last summer, but is not yet available in the United States.

It may also be some time before Medtronic's new stent is available for routine surgical implantation. A larger follow-up study and approval would be needed first, and the process could take a number of years.

The results of Medtronic's study were announced in Las Vegas on Oct. 19 at the Vascular Interventional Advances conference.