A drug-eluting stent might be significant in effectively treating erectile dysfunction. A key study that was initiated by Medtronic (Minneapolis) earlier this week seeks to see if DES can be used to successfully treat this condition that affects nearly 30 million men in the U.S.

The study, called ZEN (Zotarolimus-Eluting Peripheral Stent System for the Treatment of erectile dysfunction in males with sub-optimal response to PDE5 Inhibitors), is being performed under an investigational device exemption (IDE) issued by the FDA and is expected to enroll a total of 50 subjects at up to ten medical centers in the U.S. throughout the next year.

The company received approval to conduct the IDE about two months ago – but it's been an issue that the med-tech giant has been hoping to work on for a significant amount of time.

"We've been taking a look at this issue for a number of years," Sean Salmon, VP of Medtronic CardioVascular and general manager of Medtronic's Coronary and Peripheral business told Medical Device Daily. "Large numbers of erectile dysfunction patients have cardio vascular problems. In the last few years it's been seen that erectile dysfunction has been the precursor for cardiovascular disease."

The purpose of the study is to look at erectile dysfunction in a different light, in that it is often caused by the blockage of arteries.

"It takes blood to make the heart work and it takes blood to make the penis work so this is a natural treatment for ED," Irwin Goldstein MD, director of sexual medicine at Alvarado Hospital (San Diego) told MDD.

Erectile dysfunction could be thought of as a sort of penile angina, according to Goldstein and could in fact be treated much the same way the heart is treated by DES.

In a large number of cases ED is caused by vascular disease due to the deterioration of the endothelium. The company said that its drug-eluting stent is ideal because it preserves endothelial function of the native vessels.

To do this the company will insert a small mesh stent coated with drugs into the arteries that bring blood to the penis. The device, which hasn't been named yet, will be inserted into the pelvic area of the body.

Medtronic added that it is collaborating with urologists and interventionalists at each of the participating sites to design and execute the study in subjects who have had suboptimal response to PDE5 inhibitors, which include Viagra, Cialis and Levitra.

The study will evaluate the safety and improved erectile function of pelvic artery stenting, with results expected in 2011.

"At the end of the day we struggle with finding a cure for erectile dysfunction. We have band aids such as Viagara or Cialis but we haven't evolved into a curative therapy," Goldstein told MDD.

The first implant in the ZEN study was performed recently by a team at Prairie Vascular Institute (Springfield, Illinois), consisting of urologist Tobias Kohler, MD, and two interventionalists, Nilesh Goswami, MD, and Krishna Rocha-Singh, MD.

If the therapy proves to be feasible in the 50 patients, then Medtronic will then try for a randomized trial. If that is successful then the company said it would seek regulatory approval for the product.

"We can help patients prevent heart attacks, we can help them treat stroke . . . with this we can help with quality of life, and improve their lives," Goldstein said. "Despite breakthroughs in drug therapy, ED remains a problem for a significant number of men who have failed drug therapy and do not wish to proceed with highly-invasive second or third line therapies. We look forward to seeing the outcome of the ZEN study and evaluating the therapy's potential benefit to a patient population with limited options."

Omar Ford, 404-262-5546;
omar.ford@ahcmedia.com