MINNEAPOLIS, April 22, 2015 /PRNewswire/ -- Inspire Medical
Systems, Inc., announced today that Inspire® Upper Airway
Stimulation (UAS) therapy has been approved for inclusion in the
Government Services Administration (GSA) Federal Supply Schedule
(FSS). The agreement enables access to Inspire therapy to patients
cared for at Veteran Administration hospitals, military treatment
facilities, and Indian Health Services hospitals. Inspire therapy
is an FDA approved implantable device for the treatment of
Obstructive Sleep Apnea (OSA), a common condition affecting 18
million Americans.
According to the U.S. Department of Veterans Affairs (VA), one
out of every five war veterans has been diagnosed with
OSA—compared with only five out of 100 civilians in the general
population. Between 2008 and 2010, the number of veterans who
received medical benefits related to sleep apnea grew by 61
percent, from 39,145 cases in 2008 to 63,118 cases in
2010. Depending on the degree of severity, OSA can be a
potentially life-threatening condition. Recent research shows that
a person with poorly managed sleep apnea is at increased risk for
heart attack, stroke, weight gain, high blood pressure and heart
failure.
"With this approval, military personnel and veterans with sleep
apnea who are unable to use Continuous Positive Airway
Pressure will now have access to Inspire therapy and hopefully
a better night's sleep," said Tim
Herbert, CEO of Inspire Medical Systems. "We are very proud
of this achievement and happy that many veterans and military
personal will be able to benefit from Inspire therapy."
While Continuous Positive Airway Pressure (CPAP) is often
successful, studies show that roughly half of all patients that
start CPAP eventually become non-compliant. In contrast to CPAP,
Inspire therapy works inside the body and with a patient's natural
breathing process. The implantable system includes a small
generator, a sensing lead and a stimulation lead. Turned on by a
handheld remote, it delivers mild stimulation to key airway
muscles, which keeps the airway open during sleep. Inspire therapy
is approved to treat a subset of people with moderate to severe OSA
who are unable to use CPAP therapy.
The Tampa VA is the first VA hospital to offer Inspire
therapy. Several more VA and military hospitals are expected
to complete training and offer Inspire therapy in the second half
of 2015. Military veterans and personnel can learn more and
view hospitals offering Inspire therapy by visiting
www.inspiresleep.com.
About Inspire therapy
Inspire® Upper Airway
Stimulation (UAS) is an FDA approved treatment for people with
moderate to severe OSA who are unable to use CPAP. In contrast to
CPAP, Inspire therapy works inside the body and with a patient's
natural breathing process. The system includes a small
neurostimulator, a sensing lead and a stimulation lead. The single
external component, a handheld Inspire sleep remote, is used to
turn the therapy on before bed and off upon waking. When activated,
Inspire therapy senses breathing patterns and delivers mild
stimulation to key airway muscles, which keeps the airway open
during sleep. Patients implanted with Inspire therapy who
participated in the STAR (Stimulation Therapy for Apnea Reduction)
pivotal clinical trial experienced a 68 percent reduction in apnea
events, a 70 percent reduction in oxygen desaturation events, and
significant improvements in Quality of Life. These results were
published in the January 9, 2014,
issue of the New England Journal of Medicine. For more
information, visit:
http://www.multivu.com/mnr/7169651-fda-approves-inspire-upper-airway-stimulation-therapy-sleep-apnea
About Inspire Medical Systems
Inspire Medical Systems,
based in Minneapolis, Minn., was
formed in 2007 when the technology and a significant intellectual
property portfolio was spun-out of Medtronic (NYSE: MDT). Inspire
Medical Systems has developed the FDA approved Inspire system for
the treatment of Obstructive Sleep Apnea (OSA). Privately held,
investors include Aperture Venture Partners, GDN Holdings, Johnson
& Johnson, Kleiner Perkins
Caufield & Byers, Medtronic, OrbiMed Advisors, Synergy
Life Science Partners, TGap Ventures and US Venture Partners.
To learn more and to locate medical centers offering Inspire
therapy, visit Inspire Medical Systems on the web at
www.inspiresleep.com.
Media contacts:
Helen Shik or Rachel Gross
MSLGROUP Boston
781-684-0770
InspireMedical@mslgroup.com
Logo - http://photos.prnewswire.com/prnh/20140514/87756
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/inspire-therapy-approved-for-sleep-apnea-patients-at-military-and-va-hospitals-300070273.html
SOURCE Inspire Medical Systems, Inc.