“a solution for obstructive sleep apnea: closed loop neuromodulation : ”
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“A Solution for Obstructive Sleep Apnea: Closed Loop Neuromodulation : ”. Mark Christopherson Vice President Product Development, Inspire Medical Systems, Inc. NANS, December 6, 2012. The Inspire Therapy is Investigational Use Only in the United States - PowerPoint PPT PresentationTRANSCRIPT
Mark Christopherson Vice President Product Development, Inspire Medical Systems, Inc.
NANS, December 6, 2012
“A Solution for Obstructive Sleep Apnea: Closed Loop Neuromodulation: ”
• The Inspire Therapy is Investigational Use Only in the United States• Mark Christopherson is an employee of Inspire Medical Systems
• A loss of muscle tone during sleep allowing the upper airway to narrow or close… a physiologic issue
Definition of Obstructive Sleep Apnea
AHI = Apnea/Hypopnea Index is number of events per hour
Sufferers stop breathing for periods of up to 20-30 seconds as many as 40-50 times per hour
Breathing cessations eventually cause the brain to send what is essentially a wake-up call to the body
Many co-morbidities have been directly linked with Obstructive Sleep Apnea…
Early Mortality
High Blood Pressure
Congestive Heart Failure
Stroke
Neuro-cognitive Problems
Daytime Sleepiness
Job Impairment
Fatigue-related accidents
Health Consequences of OSA
Prevalence of OSA and Clinical Treatment Guidelines – United States
Surgical Intervention
Oral Appliance
CPAP
Remain Untreated
Fail CPAP30%-60%
Moderate to Severe OSA in
>30 yrs old:
Diagnosed20%
Many patients remain untreated or undertreated
+13 million patients
Moderate to Severe OSA Treatments
Invasiveness Low High
Intr
usiv
enes
s Lo
wH
igh (CPAP) • Gold standard
• ~1 mil units per year• Low compliance 50%
Maxillofacial advancement
• Facial reconstruction
• Good clinical results• <2k procedures / yr
Upper Airway Stimulation addresses and unmet need: Less invasive, durable results, high patient compliance
Inspire therapy
UPPPSurgical removal: tonsils,
uvula, adenoids, soft palate
• Variable results• Painful recovery• 40k procedures /
yr
The Inspire System
• No removing / altering anatomy
• Straightforward, scalable procedure
• Fast post-op recovery
• Non invasive therapy titration
Neurostimulation works WITH patient’s physiology
The Inspire System Closed-loop Synchronized Stimulation
Stimulation Lead - Self sizing cuff - Multiple stimulation vectors
Implanted Pulse Generator (IPG) - Commercial grade technology platform - 6-8 year projected longevity
Respiration Sensor - Secure, stable location - Direct measurement of respiratory effort
Upper Airway Neuro-anatomy &Stimulation Site
Stimulation Site:
Medial branch of the hypoglossal nerve, activates only protrusors (genioglossus, geniohyoid), distal to retractors (styloglossus and hyoglossus)
Styloglossus (SG)
Hypoglossal Nerve (XII)
Hyoglossus (HG)
Superior root of ansa cervicalis Genioglossus (GG)
Geniohyoid (GH)Thyrohyoid
Stimulation Site
Superior Longitudinal
Inferior Longitudinal
Mauer JT 2012
Cuff Electrode Placement on the Hypoglossal Nerve
Sensor Location: Minimally Invasive
Sensor Incision/Dissection: • Within Intercostal muscles2
3
4
5
Typical Stimulation Parameters:2.5 volts, 90 microseconds, 33 Hz
Stimulating Pulses
Sen
sor S
igna
l Expiratory
Inspiratory
Upper Airway StimulationImmediate effect on stabilizing airway
Therapy OFF Therapy ON
EEG
EMGNasal
ThermChestAbdm
SaO2
30 second
Therapy activated
Stimulation turned off
Sleep Study – Apneic events return upon Turning the Inspire system OFF
Airflow obstructionsSnoring
Effort shows patientis trying to breath
Inspire Clinical Trial Experience
Inspire 1
Proof of Principle Trial
• 8 patients
• Completed in 2001
• Demonstrated therapy concept
• Publication: Archives Otolaryngology Head Neck Surgery 2001
Inspire 2&3
Feasibility Trials
• 34 patients
• Completed in 2010
• Demonstrated safety and patient selection
• Publication: Laryngoscope 2012
Inspire STAR
Pivotal Trial(Phase 3)
• 126 patients
• Completed in Q1 2012
• 12-month data follow-up period
• Data will be submitted for FDA commercial approval
Feasibility Trial - AHI ResponsePatients meeting Pivotal Selection Criteria (N=18)
Baseline Last0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
45.0
50.0
AHI
11.6 ±934 ±6.2
AHI = Apnea-Hypopnea Index
Inspire Therapy: 20 years of Clinical Research and Product Development Experience
Feasibility Studies 2&3
Complete
STARPivotal Trial
Implants Complete
2nd GenTechnology
Development
Target for FDA approval
& US commercial
launch
MedtronicFeasibility
Study 1 Complete
20122000
• Inspire is a spin out from Medtronic
• 170+ global implants conducted at 25+ global clinical sites
• Commercially available in Europe (CE Mark received in 2010)
• The Inspire system is for Investigational Use Only in the United States
• Mark Christopherson is an employee of Inspire Medical Systems
2007
Inspire Therapy Aims to Improve Comfort, Convenience and Utilization
Patient uses Controller to: - Start, stop, pause therapy
Inspire therapyCPAP therapy
• Clinically effective• Utilization / compliance 40-
70%