New Inspire Upper Airway Stimulation Therapy 18-Month Durability Research Shows Sustained Reductions in Obstructive Sleep Apnea (OSA) Severity, Improvement In Quality of Life

Download as PDF

 

Data to Be Featured in Peer‐Reviewed Publication and in Several Scientific
Presentations at SLEEP 2015 in Seattle June 6–10

MINNEAPOLIS (June 4, 2015) — Inspire Medical Systems announced today that the
manuscript entitled, “Upper Airway Stimulation for Obstructive Sleep Apnea:
Durability of the Treatment Effect at 18 months” has been accepted for publication in
SLEEP, the official journal of the American Academy of Sleep Medicine
www.journalsleep.org

The Inspire Upper Airway Stimulation (UAS) therapy durability data demonstrates
that significant reductions in obstructive sleep apnea (OSA) severity and quality of
life measures were maintained at the 18‐month mark. The outcomes data from the
22 center Stimulation Therapy for Apnea Reduction (STAR) Trial cohort
demonstrates:

  • A 67.4 percent reduction of apnea‐hypopnea index (AHI) at 18 months.
  • Quality of life measures including daytime sleepiness and functioning
    showed clinically meaningful and significant improvement over baseline.

Inspire therapy is an FDA‐approved treatment for people with moderate to severe
OSA who are unable to use or don’t get relief from Continuous Positive Airway
Pressure (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 device is turned on with
a handheld Inspire sleep remote and, when activated, Inspire therapy senses
breathing patterns and delivers mild stimulation to key airway muscles which keeps
the airway open during sleep.

“The clinical evidence supporting the use of Inspire therapy is very strong. With the
publication of the 18‐month durability data, there are now nine peer‐reviewed
publications covering the safety, effectiveness and durability of Inspire therapy,”
says Tim Herbert, CEO of Inspire Medical Systems. “We also expect publication of
the two‐year and three‐year outcomes data in the second half of 2015.”

In addition, two‐year and three‐year objective and subjective outcomes data from
the STAR Trial will be featured during several scientific sessions at the American
Academy of Sleep Medicine (AASM)’s SLEEP 2015 meeting in Seattle, June 6‐10,
2015. SLEEP attendees can learn more about Inspire therapy and the recent
research results during the following conference presentations in Seattle:

  • Tuesday, June 9th:
    • S09: “Randomized Trials of Surgery for OSA”
  • Room 6C; 10:20 am – 12:20 pm
    • O19: “Obstructive Sleep Apnea Treatment”
  • Room 6B; 4:30 pm – 4:45 pm
    • Wednesday, June 10th:
  •  D04: “How Do New Clinical and Consumer‐Oriented Tools Fit Within the
    Practice of Sleep Medicine?”

    • Room 6B: 8:00 am – 10:00 am

Physicians attending the SLEEP conference and interested in learning more can also
visit Inspire Medical Systems at booth #620.

STAR Trial 12‐month data was first published in the January 9, 2014, edition of the
New England Journal of Medicine.

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 or don’t get relief from 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 device is turned on with a handheld Inspire sleep remote
and, 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 Stimulation
Therapy for Apnea Reduction (STAR) 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: www.inspiresleep.com

About Inspire Medical Systems
Inspire Medical Systems, based in Minneapolis, Minn., was incorporated in 2007 and
has developed the world’s first implantable FDA‐approved neurostimulation system
for the treatment of 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.