Inspire
Medical Systems, Inc., developer of the novel Inspire® Upper Airway
Stimulation (UAS) therapy for treating obstructive sleep apnea (OSA),
announced today that results from its STAR (Stimulation Therapy for
Apnea Reduction) pivotal clinical trial have been published in the
January 9 issue of the New England Journal of Medicine.
The STAR trial was a multi-center clinical study designed to evaluate
the safety and effectiveness of Inspire therapy in patients with
moderate to severe OSA who were intolerant to Continuous Positive Airway
Pressure (CPAP). The STAR trial was conducted at 22 medical centers
across the United States and Europe.
In the STAR trial, patients implanted with Inspire therapy experienced a
reduction in apnea events and improvements along several indices
designed to measure quality of life. Endpoint results reported in the
publication include:
-
68 percent median reduction in apnea hypopnea index (AHI)
-
70 percent median reduction in oxygen desaturation index (ODI)
Inspire Medical Systems is in the process of seeking approval from the
FDA for use of Inspire therapy for patients with moderate to severe OSA,
who are intolerant to CPAP.
About Obstructive Sleep Apnea (OSA)
More than 18 million Americans have sleep apnea which is characterized
by repeated episodes of upper airway narrowing and collapse during
sleep. Patients with OSA stop breathing frequently during their sleep
(apnea), often for a minute or longer. Fragmented sleep with recurrent
awakening, called arousals, leads to daytime sleepiness and fatigue.
Depending on the degree of severity, OSA can be a potentially
life-threatening condition. Recent research suggests that a person with
undiagnosed sleep apnea or a person who is noncompliant to treatment of
their sleep apnea is at increased risk for heart attack, stroke, weight
gain, high blood pressure and heart failure.
About Inspire® Upper Airway Stimulation (UAS)
Therapy
Inspire therapy is a fully implanted system that is designed to sense
breathing patterns and deliver mild stimulation to a patient’s airway
muscles to keep the airway open during sleep. Inspire therapy uses
proprietary technology that delivers stimulation therapy based on a
patient’s unique breathing patterns.
About Inspire Medical Systems
Inspire Medical Systems is based in Maple Grove, Minnesota. Inspire was
formed in 2007 when the technology and a significant intellectual
property portfolio was spun-out of Medtronic (NYSE: MDT). Visit Inspire
Medical Systems on the web at www.inspiresleep.com.
Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED
STATES) LAW TO INVESTIGATIONAL USE.
The Inspire system is an investigational device and is not currently for
sale in the U.S.
Copyright Business Wire 2014