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Suffering from ED – Medtronic May Have A Stent for That – Clinical Trials

Posted Oct 13 2009 10:01pm

A total of 50 men is the target for enrollment.  If this works Viagra could be in danger.  We keep seeing more and more devices being developed to image take the place of drugs and this is one more.  Here’s a device in the works to take the place of Warfarin, the blood thinner for one example.  There are many others I have posted about as well on the blog, so here come the devices.  Perhaps now we will see a new type of physician evolve from this the interventional urologist.   If there are any batteries included we now have this under development too, a battery pack you wear to power all your implanted devices too. 

Implantable Devices Getting Wireless External ...

When they finally get the device finished, I can almost bet it will have the capability of reporting data too, so now you would be able to fully analyze whatever it is you might want to figure out (grin).  Down the road almost every device, knee, hip, stent, etc. will have some type of data reporting capability whether it’s wireless or an implanted chip that could be read.  One condition for the trial though is that you will need to have had not very good luck with the current drugs on the market for ED. 

Press Release:

Medtronic Starts Study of Interventional Erectile Dysfunction Therapy

Novel Approach Addressing Significant Unmet Medical Need for Men with Suboptimal Response to Traditional Drug Therapies to Be Studied at Ten U.S. Sites

MINNEAPOLIS– Oct. 13, 2009 – Medtronic, Inc. (NYSE: MDT), announced today 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.

About Medtronic
Medtronic, Inc. ( www.medtronic.com ), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Medtronic Starts Study of Interventional Erectile Dysfunction Therapy

Hat Tip:  Pharmalot   (great find)

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