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Medtronic stents used in trial of ED treatment

  • Article by: JIM SPENCER
  • Star Tribune
  • October 21, 2011 - 9:04 PM

One of the slides Dr. Jason Rogers uses to explain his first-of-its-kind research on erectile dysfunction shows an image of secret agent James Bond aiming a pistol with a drooping barrel. It is a humorous moment for a serious problem, one that Rogers, a California cardiovascular specialist, and Medtronic, the Fridley-based medical device maker, believe can be treated with an approach that already works for clogged arteries.

Rogers and his research team implanted tube-like stents made by Medtronic into the pelvises of men whose erectile dysfunction (ED) had not responded to treatment with drugs such as Viagra, Cialis and Levitra. Positive results from 20 of the first 30 patients portend a possible new therapy for a condition believed to affect 30 million American men.

"These are first-in-man trials," said Rogers, a physician at the University of California-Davis Medical Center. "It is very exciting."

But, he quickly adds, the treatment requires more extensive research. Like Rogers, Medtronic is not sure that stent therapy, while a huge success for millions of heart patients, will ultimately prove adaptable to treat ED. If effective, it will likely be years before a treatment goes to market.

The positive results and a lack of side effects tantalized professionals and potential patients when Rogers reported his findings this week at a medical conference in Las Vegas. Medtronic is sponsoring Rogers and other physicians in a second study of pelvic arteries that includes 350 patients. Strong results from a larger patient pool should lend more credibility to the effectiveness.

"This is completely new research that has never been done before," said Medtronic spokesman Joe McGrath. "We're learning and writing the book as we go along. It's truly groundbreaking."

Drug therapy doesn't always work for ED, as an estimated 30 to 50 percent of men report less-than-optimal results from taking pills. The pelvic stents could provide a unique mechanical alternative. The stents are placed in internal pudendal arteries on either side of the body, insuring blood flow to the penis in a way that pills cannot, Rogers said. Pills can increase blood flow, but they cannot open clogged arteries.

Further, poor blood flow links heart disease and erectile dysfunction, Rogers said. "ED may predict cardiovascular disease."

To protect their unique discovery from competitors, neither Rogers nor Medtronic would discuss whether the type of stent being used to treat erectile dysfunction is similar or even the same as Medtronic's heart stent. Nor would they talk about whether the implantation procedure is the same as for a heart stent.

Cardiovascular specialists and urologists screened patients in the initial Medtronic-sponsored study to make sure that they had erectile dysfunction that had not responded to drug therapy. In measuring the success of the implanted stents, researchers did not just take the word of the study's subjects.

Patients answered a scientifically accepted 15-question "assessment tool" used in the evaluation of other erectile dysfunction treatments, Rogers said. That subjective evaluation showed two-thirds of the patients describing significant improvement in erectile function.

"Some of that could be placebo effect," Rogers said. To rule out imagined improvement, Rogers and his partners performed ultrasound tests on the patients that showed actual increases in blood flow.

Nevertheless, Rogers carefully avoided describing pelvic implants as a substitute for Viagra and other ED pills.

"We see this as an adjunct to current therapy," he said. "We can't recommend that doctors start doing this."

Even if the therapy turns out to be feasible and effective, and gains regulatory approval, there is no way to make it or any other erectile dysfunction treatment foolproof, Rogers said.

"We have a saying about ED," he noted. "It's between the legs, between the partners and between the ears."

Jim Spencer • 202-408-2752

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