A Maple Grove med-tech company has won approval to begin a large clinical trial for its implantable neuro-stimulator, which is designed to help people with obstructive sleep apnea.
Inspire Medical, founded in 2007 with technology spun out of Medtronic,
announced last week that the U.S. Food & Drug Administration signed off on a 100-plus-patient clinical trial for the therapy.
"It's the key trial that collects the data necessary for U.S. approval," CEO Tim Herbert said.
The study will test an alternative treatment for
obstructive sleep apnea, a condition in which the tongue and throat muscles relax during sleep and cause the airway to collapse. People with the condition briefly wake up and gasp for breath as many as 30 to 50 times an hour.
The most common treatment today is called continuous positive airway pressure, or CPAP. It's a mask that needs to be worn while sleeping and that blows air down the airway with enough pressure to keep it from closing.
"It's a very effective therapy. It's a very efficient therapy. The problem is you have to wear that mask and it's not really comfortable for a lot of people," says Herbert.
Herbert says research has shown that about 50 percent of people who are prescribed a CPAP are no longer using it a year later. Untreated, the condition can increase the odds of a stroke, hypertension, not to mention fatigue.
Inspire's treatment is an implantable system, similar to a pacemaker. Only instead of sending electrical pulses to the heart, the device sends tiny jolts to a nerve under the chin that controls the tongue and throat muscles.
The system is approved for sale in Europe. The company's clinical trial will begin enrolling patients early next year and likely take about two years to be completed. The company has 12 employees and outsources its manufacturing work to other companies, including Medtronic.
Herbert said the company is working toward having the therapy approved for sale in the United States by 2013.
Source: Tim Herbert, Inspire Medical Systems
Writer:
Dan Haugen