Treatment Goals for OSA Patients
• Reduce Symptoms• Improve Quality of Life• Reduce Accident Risk• Minimize Cardiovascular
and Other Health Risks
Clinical Data Update Summary of published long-term 3-year outcomes data
Inspire Therapy for Obstructive Sleep ApneaFor OSA patients unable to tolerate or get
consistent benefit from CPAP
Consequences of Untreated Obstructive Sleep Apnea (OSA)
*Excerpt from a sleep study of an Inspire therapy candidate
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• Untreated OSA can have devastating effects on heart and brain health, impair quality of life and increase motor vehicle and occupational accident risk
AIRFLOW
Airway Obstruction:47 seconds
Airway Obstruction:86 seconds
• During sleep, OSA patients experience repetitive airway obstructions followed by oxygen desaturations
1. Artz et al., Am J Respir Crit Care Med 2005 2. Young et al., Sleep 2008 3. Peppard et al., N Engl J Med 2000 4. Tregear et al., J Clin Sleep 2009 5. Shahar et al., Am J Respir Crit Care Med 2001 6. Lindberg et al., Am J Respir Crit Care Med 2001 7. Reichmuth et al., Am J Respir Crit Care Med 2005 8. Smith et al., CHEST 2002 9. Gottlieb et al., S Circulation. 2010
OXYGEN SATURATION LEVEL
84% 74%
• Moderate to severe OSA patients can experience hundreds of obstructions and desaturations each night90%
INCREASED RISK DUE TO UNTREATED OSA
Desaturation (45.13s) [13] Desaturation (91.83s) [24]
Odds RatioHazard RatioRelative Risk
OSA Treatment Shown to Reduce Cardiovascular Events
• Untreated severe OSA (AHI of 30+) is associated with an increased risk of both fatal and non-fatal cardiovascular events
• Consistent treatment with Continuous Positive Airway Pressure1 (CPAP) or an AHI
The Hypoglossal Nerve (Cranial Nerve XII)The Basis for Inspire Upper Airway Stimulation Therapy
• Motor nerve
• Controls the muscles and movements of the tongue
• Mild stimulation of the distal hypoglossal nerve restores upper airway muscle tone
• Increase in muscle tone can prevent the tongue and other soft tissues from collapsing and obstructing the airway during sleep
Adapted from IVLine.org
Stimulation Synched with BreathingThe Inspire System Delivers Therapy When Airway is
Most Vulnerable to Collapse
• Fully implanted system that uses well-established technologies and surgical techniques
• Breathing sensor monitors a patient’s breathing cycle
• Rhythmic, mild stimulation is delivered to the hypoglossal nerve through the stimulation cuff
• Mild stimulation is delivered during inspiration, when the OSA patient’s airway is most vulnerable to collapse
1
2
3
1) Stimulation Cuff2) Generator3) Breathing Sensor
Safiruddin, et al. European Respiratory Journal, January 2015
Stimulation Effect on Airway Anatomy
No Stimulation Mild Stimulation
Obstructed Airway
Palate Palate180% increase
in airway dimension130% increase
in airway dimension
Tongue Base Tongue Base
Open Airway
*Endoscopy images of an Inspire therapy recipient
At therapeutic titrated levels, Inspire therapy prevents the airway from collapsing to
facilitate unobstructed breathing
Stimulation Effect During Sleep
• Airflow and breathing stabilized
• Normal SaO2 levels restored
• Uninterrupted sleep continues without arousals
*Sleep study of an Inspire therapy recipient
Inspire therapy turned on
Airflow
Breathing
SaO2
Severe OSA Events OSA Events Resolved
Inspire Therapy Clinical Evidence Development
12 peer-reviewed publications as of November 2015
ONGOING STUDIES
STAR PHASE III TRIAL WITH RANDOMIZED
CONTROLLED WITHDRAWAL STUDY
Safety/Efficacy
FDA Approval
Long-Term Follow-Up
Cost Effectiveness
8 Peer-Reviewed Publications
European Post-Approval Study
US Post-Approval Study
Multiple Single Center Experience Projects
European Randomized Controlled Study
First in Man
Patient Selection
Implant Technique
Safety/Efficacy
4 Peer-Reviewed Publications
INSPIRE 1, 2, 3 FEASIBILITY STUDIES
Peer-Reviewed STAR Trial Outcomes Publications:
One Year: Upper Airway Stimulation for Obstructive Sleep Apnea. Strollo et al. The New England Journal of Medicine. January 2014
Randomized Study:
Randomized Controlled Withdrawal Study of Upper Airway Stimulation on OSA. Woodson et al. Otolaryngology Head and Neck Surgery. September 2014
18 Months: Upper Airway Stimulation for Obstructive Sleep Apnea—Durability of the Treatment Effect at 18 months. Strollo et al. SLEEP. June 2015
Two Year: Upper Airway Stimulation for Obstructive Sleep Apnea: Self-Reported Outcomes at 24 months. Soose et al. Journal of Clinical Sleep Medicine. July 2015
Three Year: Three Year Outcomes of Cranial Nerve Stimulation for Obstructive Sleep Apnea: The STAR Trial. Woodson et al. Otolaryngology Head and Neck Surgery. November 2015
Inspire Therapy Long-Term Objective Outcomes
Patients using Inspire therapy experienced significant decreases in both AHI and ODI from baseline to 12 months. These significant improvements were maintained over the 36-month follow-up period.
Reduced OSA Severity: AHI
29.3
9.0 9.7 6.2
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
Baseline N=126
12 Month N=124
18 Month N=121
36 Month N=98
Apnea Hy
popnea Index
Results in median All p values < 0.01 vs. baseline
Reduced OSA Severity: ODI
25.4
7.4 8.6
4.8
0.0
5.0
10.0
15.0
20.0
25.0
30.0
Baseline N=126
12 Month N=124
18 Month N=121
36 Month N=98
Oxygen De
saturaKo
n Index
Results in median All p values < 0.01 vs. baseline
All p values < 0.01 vs. baseline. Results in median.
All p values < 0.01 vs. baseline. Results in median.
OXYGEN DESATURATION INDEX (ODI)
APNEA HYPOPNEA INDEX (AHI)
Improved Day8me Func8oning: FOSQ
14.6
18.2 18.4 18.8
10 11 12 13 14 15 16 17 18 19 20
Baseline N=126
12 Month N=123
18 Month N=123
36 Month N=110
FuncKo
nal O
utcomes o
f Sleep QuesKonnaire
Normalized daytime functioning
Results in median All p values < 0.01 vs. baseline
Reduced Day8me Sleepiness: ESS Scale
11.0
6.0 6.0 6.0
4
5
6
7
8
9
10
11
12
Baseline N=126
12 Month N=123
18 Month N=123
36 Month N=110
Epworth Sleepiness S
cale
Normalized dayKme sleepiness
Results in median All p values < 0.01 vs. baseline
Inspire Therapy Long-Term Patient Reported Outcomes
Patients using Inspire therapy reported significant improvements and normalization of both daytime sleepiness and daytime functioning. These significant improvements were reported at 12 months and were sustained at 36-month follow up.
All p values < 0.01 vs. baseline. Results in median.
All p values < 0.01 vs. baseline. Results in median.
EPWORTH SLEEPINESS SCALE (ESS)
FUNCTIONAL OUTCOMES OF SLEEP QUESTIONNAIRE* (FOSQ)
* Importantly, all 5 FOSQ subscale variables showed clinically significant improvements. FOSQ subscale variables include (1) activity, (2) productivity, (3) social, (4) intimacy and (5) vigilance.
Inspire Therapy Adherence
86% 81% 81%
93% 86% 87%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
12 Month N = 124
24 Month N = 117
36 Month N = 108
Use every night (%) Use at least 5 nights a week (%)
Patient Self-Reported
From STAR database
Inspire Therapy Patient and Partner Experience
Sleep apnea affects not only patients but their bed partners as well. Snoring, a common sleep apnea symptom, was significantly impacted in patients using Inspire therapy from baseline. Additionally, fewer partners left the room due to their partner’s snoring.
PARTER REPORTED SNORING OUTCOMES
THERAPY ADHERENCE
Bed partner leaves roomNo or soft snoring
Therapy adherence remained high throughout the three-year follow-up period.
50%
40%
30%
20%
10%
0%
30%
BaselineN=108
5%
12 MonthN=103
4%
18 MonthN=103
3%
36 MonthN=97
100%
80%
60%
40%
20%
0%
17%
BaselineN=108
86%
12 MonthN=103
87%
18 MonthN=103
80%
36 MonthN=97
Inspire Therapy Patient Selection Considerations
Patients use the handheld sleep remote to turn the therapy on before bed and off upon waking.
Inspire therapy is FDA-approved and available at over 50 leading medical centers in the United States. It is intended for people who:
• Have been diagnosed with moderate to severe OSA (AHI 20-65)• Cannot tolerate or get consistent benefit from CPAP• Are not significantly overweight
People who meet these basic criteria can be referred to a specialist who can evaluate sleep parameters, assess the airway anatomy and determine if Inspire therapy is right for them.
In addition, Inspire therapy is approved and available in over 8 European countries.
Visit www.inspiresleep.com to review risks, benefits and expectations associated with Inspire therapy. Risks associated with the surgical implant procedure are low but may include infection and temporary tongue weakness. Most patients acclimate well to the presence of the Inspire system and to the therapeutic stimulation. Some patients may require post-implant adjustments to the system’s settings in order to improve effectiveness and ease acclimatization.
Additional Resources:www.InspireSleep.com844 OSA HELP (844-672-4357)
© Inspire Medical Systems, Inc. 2015. All Rights Reserved. 800-132-001 Rev A Nov 2015
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