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Blind trials: Tried and tested
Despite uncertainty, blind clinical trials can give patients a quicker route to new treatments.
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Before closing a hole in a heart
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A hospital gown hung limply on Shelley Sable’s small frame as she waited in a cubicle at Abbott Northwestern Hospital just over a year ago. The waiting was tedious. Nurses checked, rechecked and then triple-checked her vital information before she was finally wheeled into an operating room for a heart procedure.
Or no procedure at all. Sable, now 44, had eagerly enrolled in a clinical trial that is probing a possible link between the small hole in her heart and the crippling migraine headaches she’s suffered for the past 16 years.
The 400-patient study is sponsored by Plymouth-based AGA Medical Corp., which makes a device that plugs the hole, called a patent foramen ovale, or PFO.
Because the study is double-blinded, Sable and her physician did not know for the past year whether she was treated with the device, although she certainly had her suspicions. And even if she was treated with the device, there was no guarantee that it would work.
The Rosemount resident is among the hundreds — perhaps thousands — of patients each year who agree to enroll in studies testing experimental medical devices and drugs. Their participation is crucial for companies hoping to prove their device is safe and effective, and an essential step before gaining regulatory approval to sell the product.
“If we didn’t have people like Shelley willing to enroll in clinical trials, the medical field would not be where it is today,’’ said Dr. Anil Poulose, a cardiologist with the Minneapolis Heart Institute, who is involved in the AGA study.
Sable, a nurse, thinks the possible link between her heart and brain makes sense. After suffering, on average, one to three migraines a week for most of her adult life, Sable was willing to consider unusual alternatives.
The experimental part of the bargain didn’t bother her one bit.
A swinging door
The path to that chilly hospital cubicle has been a fortuitous one not only for Sable, but for companies making devices intended to plug the hole in the heart.
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Blog: Patent Pending
Meanwhile, in Wisconsin....
As you read this blog entry, angel investors and start-ups are flocking to Madison, Wisconsin for the annual Wisconsin Early Stage Symposium and the Mid West Health Care Venture forum.
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