Medtronic, Inc. (NYSE: MDT), has announced the initiation of a feasibility study of an interventional treatment for erectile dysfunction (ED) that uses a specially-designed drug-eluting stent system. 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 U.S. Food and Drug Administration and is expected to enroll a total of 50 subjects at up to ten medical centers in the United States over the next year.
“The link between erectile dysfunction and coronary artery disease has been well established; 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,” said Dr. Jason Rogers, director of interventional cardiology at UC Davis Medical Center in Sacramento and one of the ZEN primary investigators. “Understanding that in a large number of cases ED is caused by vascular disease due to the deterioration of the endothelium, and that Medtronic’s drug-eluting stent (DES) preserves endothelial function of the native vessels, Medtronic’s DES technology is uniquely suited to be studied for this condition.”
Medtronic 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.
The first implant in the ZEN study was performed recently by a team at Prairie Vascular Institute in Springfield, Ill., consisting of urologist Dr. Tobias Kohler, and two interventionalists, Drs. Nilesh Goswami and Krishna Rocha-Singh.
“It’s exciting to see the field of interventional medicine advancing in new areas,” said Dr. Rocha-Singh, medical director of Prairie Vascular Institute, and one of the ZEN primary investigators. “However, it’s vitally important that we study promising new approaches in the clinic as historical data have shown the importance of properly identifying subjects so that we are targeting those who will benefit most from this novel therapy.”
“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,” said Dr. Irwin Goldstein, director of sexual medicine at Alvarado Hospital in San Diego, editor-in-chief of The Journal of Sexual Medicine and one of the ZEN primary investigators. “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.”
“Erectile dysfunction represents an unmet medical need for physicians and patients,” said Sean Salmon, vice president and general manager of Medtronic’s Coronary and Peripheral business. “The ZEN study represents Medtronic’s interest in addressing this need, while also serving as a potential opportunity to broaden our pipeline of interventional therapies. Importantly, Medtronic has the support of both the urology and the interventional communities as we embark on a path to pioneer a new treatment for ED.”
Medtronic CardioVascular is committed to advancing the treatment of coronary, peripheral, aortic and structural heart disease through collaboration with leading clinicians, researchers and scientists worldwide.