A pacemaker-like device that sends electric pulses to nerves in Jackie Kopplin’s tongue controls her sleep apnea, and may soon lift the fortunes of the small Maple Grove company that makes it.
Inspire Medical Systems has been developing the technology for years, but an article published Wednesday in the New England Journal of Medicine calls attention to the device that stimulates the tongue to get out of the way of breathing. Results of clinical trials were so positive that experts predict the technology may become a viable alternative for patients who can’t tolerate continuous airway pressure (CPAP) machines.
“I was trying the CPAP and that wasn’t working. I just kept pulling it off of my face because I just didn’t like it — the air blowing in my nose all the time,” said Kopplin, 45, of Coon Rapids. “Before, I quit breathing anywhere from 35 to 40 times an hour. Now, I can actually sleep through the night. ”
The article highlights Inspire’s Stimulation Therapy for Apnea Reduction (STAR) trial, which followed participants for a year after the device was implanted, and showed that upper-airway stimulation was safe and effectively treated moderate to severe obstructive sleep apnea. In addition, the study’s investigators said, the technology significantly decreased sleep apnea events and showed a reduction in the effects of sleep apnea and improved quality of life.
Obstructive sleep apnea is a sleep disorder that occurs when the tongue and other soft tissues relax during sleep, obstructing the airway and preventing fresh air from reaching the lungs. Without fresh air, the oxygen level in the blood decreases. The brain arouses the body from sleep just long enough to open the airway.
This fitful sleep cycle can repeat many times an hour over the course of a night, and its cumulative effects can lead to serious health problems, including high blood pressure and heart failure. According to the National Heart, Lung, and Blood Institute, more than 12 million people in the United States have sleep apnea.
Tim Herbert, president and CEO of the 24-employee private company that spun off from Medtronic in 2007, said: “We’ll probably have 50 employees by this time next year.”
That’s because the trial results appear likely to persuade U.S. regulators to approve the device for a sleep apnea market expected to hit $7 billion by 2017.
CPAP not for everyone
The most common and effective treatment of the disorder is CPAP. Patients wear a mask that keeps airways open by blowing air into the nose and mouth during sleep. CPAP is not effective, however, if patients do not wear their mask or cannot tolerate the therapy, said Dr. Jason Cornelius, a neurologist and sleep specialist with the Minneapolis Clinic of Neurology and medical director of the North Memorial Sleep Health Centers.
“We know that CPAP is an excellent first-line therapy,” he said. “But the CPAP is only as good as your compliance with it.”
Cornelius, who was a principal investigator in the STAR trial and had 16 patients enrolled in the study, said Inspire’s technology “really gives us a new tool to help manage patients.”
The Inspire device, which is implanted in the chest, has a generator connected to two wires: one that senses when a patient’s lungs begin inhaling and another that stimulates the nerves of the tongue. The electric pulse makes the tongue move out of the airway each time the patient inhales.
“It was really amazing to see the transformation of some of these folks, to have something that was robustly effective,” said Cornelius, who was reimbursed for participating in the trial but has no financial stake in the company. “These patients had dramatic improvements in quality of life.”
Kopplin had her device implanted in July 2011 and was soon wondering if she had made a mistake in getting rid of her CPAP. Soon after her surgery, the incision became inflamed and painful. “It was like I had a basketball under my chin,” she said.
Anti-inflammatory medications and an attentive medical team helped, she said. After several weeks, the pain and inflammation were gone. After a couple months of adjustments, she was sleeping well and feeling rested. She recently had her 30-month checkup.
“Before, I couldn’t go out the door without always being tired. I was constantly dozing off,” said Kopplin, who runs her own housecleaning business. And now? “I would recommend it. But I would say you are going to have some pain.”
“Still,” she added, “You will feel better.”
Inspire’s device has been approved for sale in Europe and has limited availability there, but still needs U.S. Food and Drug Administration approval for sale in this country. An advisory panel is scheduled to meet Feb. 20 and could make a recommendation.
Suraj Kalia, an analyst with Northland Securities, said Inspire “is not on the radar screen for the majority of investors.” He expects that to change with FDA approval, which could happen before the end of this year.
While the Inspire technology is more expensive than CPAP — up to an estimated $30,000, including surgical and recovery costs, vs. $1,000 for a CPAP — Kalia said the possibility of savings down the road by reducing apnea-related health costs makes it “compelling.”
“For a company like Inspire, they are starting from ground zero,” Kalia said. “I could see them easily growing to $200 million-plus in revenues very quickly.”