Medtronic's ZEN Study to Address Use of DES to Treat ED

October 13, 2009—Medtronic, Inc. (Minneapolis, MN) 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 ZEN (Zotarolimus-Eluting Peripheral Stent System for the Treatment of Erectile Dysfunction in Males with Sub-Optimal Response to PDE5 Inhibitors) study is being performed under an investigational device exemption issued by the US Food and Drug Administration. ZEN is expected to enroll a total of 50 patients at up to 10 medical centers in the United States over the next year. The study will evaluate the safety and improved erectile function of pelvic artery stenting, with results expected in 2011.

Medtronic stated that it is collaborating with urologists and interventionists at each of the participating sites to design and execute the study in subjects who have had suboptimal response to PDE5 inhibitors. The first implant in the ZEN study was performed by interventionists Nilesh Goswami, MD, and Krishna Rocha-Singh, MD, and urologist Tobias Kohler, MD, at Prairie Vascular Institute in Springfield, Illinois.

"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," commented Jason Rogers, MD, 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 preserves endothelial function of the native vessels, Medtronic's DES technology is uniquely suited to be studied for this condition."

Irwin Goldstein, MD, Editor-in-Chief of The Journal of Sexual Medicine and one of the ZEN primary investigators, added, "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."