Recent studies are showing positive results with penile stents which could lead to them becoming serious rivals to the erectile dysfunction medications Viagra, Stendra, Cialis and Levitra! The research showed an almost 70 percent improvement in erections three months after they were inserted surgically into the penile artery. The study, which was financed by Medtronic, showed no adverse affects or health problems as a result of the surgery.
Dr. Jason Rogers of UC Medical Center and a researcher of this Medtronic-sponsored trial commented that ED is basically a vascular disease and this is the main reason why the company has so much interest in it.
It has been estimated that there are about 30 million men in the United States who are suffering from ED, and about 300 million across the world.
Rogers also said that about 50 percent of men suffering from ED stopped drug therapy which included Viagra, Levitra and Cialis as a result of them not working, or developing intolerable side effects which included low blood pressure.
Research & Studies
The new study which was made public at a meeting for the Vascular Interventional Advances recently held in Las Vegas involved stents being inserted into 30 men of an average age of 60 all of whom suffered from erectile dysfunction.
Stents are tube-shaped medical devices often used to prop open blocked arteries to the heart. They have been used in thousands of patients for heart problems. Now researcher are looking to use the same technology for erectile dysfunction, implanting it in men below the waist to treat ED.
Stents are commonly implanted in diseased arteries to help improve blood flow. And erectile dysfunction — which affects about 30 million American men — is sometimes caused by a blocked vessel impeding blood flow to the penis, according to Dr. Tobias Kohler, a urologist at Southern Illinois University School of Medicine. This research represents a perhaps never-seen-before collaboration of vascular interventionalists and urologists/sexual-medicine specialists.
Kohler has teamed up with four interventional cardiologists at the Prairie Heart Institute at St. John’s Hospital, Springfield, on the first phase of a clinical study called ZEN that is testing the safety and feasibility of a drug-coated stent for erectile dysfunction.
Dr Jason Rogers – UC Davis Medical Center, stresses that the etiology of erectile dysfunction is multifaceted—”between the legs, between the couple, and between the ears,” and that straightening out just who is the ideal candidate for an invasive therapy such as this will take time.
Medical technology giant, Medtronic Inc.’s is also involved in developing drug-coated stents.
Safe and Effective
The stent is safe and improves erectile function in men who don’t respond to conventional therapy such as Pfizer Inc.’s Viagra, Bayer AG’s Levitra and Eli Lilly & Co.’s Cialis, according to a study released yesterday at the annual meeting for Vascular Interventional Advances in Las Vegas. The Medtronic’s clinical trial is the first to test stents for treating impotence in men who don’t respond to drug therapy, researchers said.
The study found 68 percent improvement in erectile function after three months in 30 men with an average age of 60 who were implanted with the stents. Their impotence was caused by narrowed pudendal arteries in the pelvis. There were no issues such as clots or the need for surgery one month after treatment in the study funded by Minneapolis-based Medtronic.
Men can experience erectile dysfunction at any age, but half of men over 50 will experience it at least some of the time, Kohler says.
And, contrary to the myth that it’s all about desire, erectile dysfunction is typically caused by a physical problem, such as disease, injury or medication side effects. Lifestyle choices such as poor diet, being overweight, drinking too much alcohol and smoking also raise the risk.
The stent—a tiny wire mesh tube similar to those used to prop open heart arteries—was placed in the internal pudendal artery, which supplies blood to the penis.
The stent was delivered using a catheter threaded up to the pelvis, where the pudendal artery is located. It was placed in the artery, opening the vessel and allowing for better blood flow.
“ED is largely a vascular disease and that’s why Medtronic was interested in this,” said Dr. Jason Rogers of UC Davis Medical Center, one of the researchers of the company-sponsored trial. About 75 percent of the time, erectile dysfunction is linked to vascular disease, and 75 percent of men with coronary artery disease also experience problems in the bedroom, according to Medtronic Inc., the medical technology company that developed the new stent system.
Kohler and his colleagues performed the first ZEN procedure in Springfield a year ago, and Medtronic spokesman Joseph McGrath said there are now 13 sites enrolling patients in this clinical trial.
To date, 40 percent of the procedures have been performed in Springfield, he said. The company declined to identify most of the trial sites due to competitive factors, but did say three of the sites (Springfield and two others in California) are at the institutions of doctors serving as principal investigators.
Dr. Krishna Rocha-Singh, an interventional cardiologist and principal investigator in Springfield, said one of the challenges in the ZEN trial is that it requires the collaboration of two medical subspecialties that don’t often work together — urologists and interventional cardiologists.
Drug-coated stents can resolve problems for patients suffering heart pain or a heart attack, Rocha-Singh said, so it stands to reason that stents would hypothetically have a similar effect on opening up blockages affecting blood flow to the penis.
Why undergo surgery at all when the little blue pill is available? Not all men respond to Viagra and many men have serious side effects. New drugs such as Avanafil, promis fewer side effects, but still carry some risk.
When Viagra fails
Erectile dysfunction drugs such as Viagra, Stendra, Cialis and Levitra help dilate arteries to increase blood flow, Kohler said, and they’re effective in about two-thirds of erectile dysfunction cases. But they don’t tend to work with dysfunction that is severe or long-lasting, he adds.
When the drugs fail, men sometimes turn to more intrusive or invasive therapies such as a penile implant or injections, Kohler said. Penile implants require an involved surgery. There’s a risk of infection and a risk that the device won’t work. But new materials, designs and surgical procedures have greatly improved results. Most men with penile implants and their partners say they’re satisfied with the results.
The new stent procedure could prove to be a less invasive option to try next, he said. It’s done on an outpatient basis, and men typically recover in a day or two.
In heart angioplasty a sheath (a thin plastic tube) is inserted into an artery — usually in your groin, but sometimes in the arm. A long, narrow, hollow tube, called a catheter, is passed through the sheath and guided up the blood vessel to the arteries surrounding the heart.
A small amount of contrast material is injected through the catheter and is photographed as it moves through the heart’s chambers, valves, and major vessels. From the digital pictures of the contrast material, the doctors can tell whether the coronary arteries are narrowed and/or whether the heart valves are working correctly. The procedure usually lasts about 1 1/2 to 2 1/2 hours, but the preparation and recovery time add several hours and sometimes a overnight stay for observation.
Early results from the research suggests suggest that this novel use for a DES is safe and associated with significant improvement in erectile function and satisfaction. But the trial also encountered logistical problems related to the uncharted complex terrain of the pelvic vasculature, meaning that the next trial in this arena is going to take a step back.
Medtronic was founded in 1949 as a medical equipment repair shop by Earl Bakken and his brother-in-law, Palmer Hermundslie. Since then, we’ve grown into a multinational company that uses technology to transform the way debilitating, chronic diseases are treated.
The inspiration for Medtronic’s first pacemaker was a musical metronome.
Our first life-changing therapy – a wearable, battery-powered cardiac pacemaker – was the foundation for dozens more Medtronic therapies that use our electrical stimulation expertise to improve the lives of millions of people.
Over the years, we adapted additional technologies for the human body, including radio frequency therapies, mechanical devices, drug and biologic delivery devices, and diagnostic tools. Today, our technologies are used to treat more than 30 chronic diseases affecting many areas of the body.