News | October 14, 2009

Medtronic Study Uses Stents to Treat Erectile Dysfunction

October 14, 2009 – Medtronic Inc. yesterday initiated a feasibility study of an interventional treatment for erectile dysfunction (ED) that uses a specially-designed drug-eluting stent (DES) 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 10 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 Jason Rogers, M.D., director of interventional cardiology at University of California 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 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 Tobias Kohler, M.D., and two interventionalists, Nilesh Goswami, M.D., and Krishna Rocha-Singh, M.D.

“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 Irwin Goldstein, M.D., 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.”

For more information:

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init