A Maple Grove company is on the forefront of a new technology that could revolutionize the way sleep apnea is treated and help millions of sufferers from the sleep disorder get a better night's rest.
After 15 years of development, Inspire Medical Systems of Maple Grove, a spinoff of Medtronic, now has an implantable pacemaker-style device that could prove to be an alternative to the most common sleep apnea treatment, the CPAP, a night-time mask worn while sleeping.
Sleep apnea is a disease that affects at least 15 million Americans. During sleep, the airway collapses and breathing is interrupted, so patients don't sleep well.
While the CPAP mask, hooked to a bedside machine, continuously pushes air through the mask to keep the airway open, the Inspire device is implantable.
"We implant the device below the skin, and it stimulates the hypoglossal nerve that's just underneath the chin," said Tim Herbert, president and CEO of Inspire Medical. "When it stimulates, it pulls your tongue forward and opens up your airway."
The Inspire device has already been tested in three feasibility studies with patients. Now the company needs to complete one final clinical study, called a pivotal trial, in order to get approval from the FDA.
"It's no longer if this technology is going to be come available someday, it's when is it going to be available," said Herbert.
Dr. Oleg Froymovich, a leading sleep apnea specialist in the Twin Cities, will surgically implant the new device in patients for the final study.
"It's very exciting, it's a whole new area," said Froymovich of Paparella Ear, Head, and Neck Institute in Maple Grove. "It's a new way of thinking [about sleep apnea treatment], it's the new approach."
Sleep apnea can lead to a whole host of serious health problems including heart disease, hypertension, diabetes, heart attacks, strokes, and obesity.
"The reality is sleep apnea is rampant in our society. We're beginning to see the meaning and the true impact of sleep apnea on our social infrastructure as well as on our health in general," said Froymovich.
If you're interested in learning more about the Inspire clinical study visit www.theSTARtrial.com or call 1-888-844-4811.
Alexandra Renslo reporting
Wednesday, June 15, 2011