introduction to inspire therapy - ear, nose, throat & plastic surgery associates

© Inspire Medical Systems, Inc. 2015 All Rights Reserved

800-115-001, Rev A

Training Module #1

Introduction to Inspire Therapy

www.inspiresleep.com


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Program Training Curriculum

2

Module 1:

Introduction

to Inspire

therapy

Module 2:

DISE

Module 3: Prior

authorization

Module 4:

Implant

Module 5: OR

prep

Module 6:

Activation /

titration and

programmer

Who needs

training?

Any AHP or

MD that will

discuss Inspire

therapy with

patients

Physician that

will perform

DISEs

MD and staff

that submit prior

authorizations

Implanting

surgeon(s)

OR staff that

will support

Inspire therapy

implants

Any MD, AHP

or night tech

that will work

programmer at

activation or

titration

Who conducts

the training?

Local Inspire

territory

manager

Inspire

technical

training group

Inspire prior

authorization

team

Inspire

technical

training group

Local Inspire

territory

manager

Inspire

technical

training group

Where is the

training?

At center At center At center Cadaver lab

Tampa or

Phoenix

At center At center

When is the

training

conducted?

Immediately

post selection

(Site Visit or

Kickoff)

Once first

patients have

been screened

and scheduled

for DISE

Once first

patients have

passed DISE

Once site has

two patients

scheduled for

implant

After surgeon

has been

trained and

one week prior

to 1st case

After first

implant and

prior to first

device

activation

Goal: Move through this

process in 6-8 weeks


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Module 1: Introduction to Inspire Therapy

Section 1 – information for health care professionals

• Indications overview

• How Inspire therapy works

• Episode of care overview

• Therapy implementation

Section 2 – “Patient Introduction to Inspire”

• Inspire therapy overview

• Who are good candidates for Inspire therapy

• Patient assessment overview

• Inspire therapy implementation

• Inspire therapy reimbursement Q&A

• Other frequently asked questions from patients


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Section 1:

Inspire Therapy for Healthcare Professionals

• Indications overview

• How Inspire therapy works

• Episode of care overview

• Therapy implementation


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Inspire Therapy Indications

• Adults 22 years of age and older

• Diagnosed OSA with an AHI range of 20-65 per hour

• CPAP failure or inability to tolerate CPAP treatment:– PAP failure is defined as an inability to eliminate OSA (AHI of greater than

20 despite PAP usage), and PAP intolerance is defined as:

– Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night).

– Unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it).

• Appropriate airway anatomy

Indications Overview


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Inspire Therapy Contraindications

• Screening sleep study shows > 25% central+mixed apneas

• Anatomical assessment findings that could compromise the performance

of Inspire such as complete concentric collapse (CCC) at the palate

• Pre-existing conditions that have compromised neurological control of

the upper airway

• Patients who are unable or do not have the necessary assistance to

operate Inspire therapy

• Patients who are pregnant or plan to become pregnant

• Patients who will require MRI

• Patients with another implantable device (ex. pacemaker) should consult

the device manufacture to assess possibility of interaction



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Inspire Therapy Warnings and Precautions

• Body Mass Index ≤ 32

– BMI > 32 may be associated with decreased likelihood of response to

treatment

• Diathermy (primarily used in physical therapy)

– Do not use shortwave diathermy, microwave diathermy or therapeutic

ultrasound diathermy on patients with a neurostimulation system

• MRI can cause tissue damage as well as damage to the Inspire

system and components

• Electromagnetic compatibility and interference (EMI). Extremely

strong sources of EMI could interfere with normal IPG operation

– Electrocautery, irradiation, lithotripsy, RF-ablation, x-ray, and fluoroscopy

are typical EM disturbance sources. Treatments that use ultrasonics,

defibrillation, or radiation can adversely affect the Inspire System.



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Inspire Therapy Overview

• Inspire therapy:– Works inside the body - fully implanted

– Monitors breathing patterns during sleep

– Delivers mild stimulation to key airway

muscles to keep airway open during sleep

– Turned on and off with a handheld

sleep remote

8

Sleep Remote

How Inspire Therapy Works


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Multi-level Mechanism of Action

• Therapeutic effect is evident at both the palate and tongue-base

• More prominent response with increasing stimulation energy – within

therapeutic range

Safiruddin F, et al. Effect of upper-airway stimulation for obstructive sleep

apnoea on airway dimensions. European Respiratory Journal, 2014.



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Inspire Therapy – Sleep Study Illustration

Inspire therapy turned on

Severe OSA Events Resolved

Airflow

SpO2

Inspire therapy effect during

polysomnography

Airflow, breathing and normal oxygen levels restored



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Pre Implant – Episode of Care Summary

ENT SurgeonSleep or ENT

Surgeon

A multi-disciplinary team consisting of a sleep physician and ENT

surgeon is responsible for carefully selecting the right patient to

receive Inspire therapy

ScreeningSurgical

ConsultDISE

Insurance Prior Auth.

Implant

Episode of Care Overview


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What Pre Implant Follow-up is Needed?

• The sleep MD or ENT surgeon should perform all necessary screening activities– pre-implant sleep study, evaluation of indications, patient interest in surgery

• Each patient should undergo a full consultation with the ENT surgeon to discuss the surgery and evaluate their airway

• The ENT surgeon should perform a Drug Induced Sedated Endoscopy (DISE) toassess the airway collapse pattern and to rule out complete concentric collapse at the palate, which is contraindicated

• Once the patient has been properly screened and assessed, a prior authorization for payment of benefits will be submitted to the patient’s insurance company typically by the ENT surgeon’s office

• Once a determination of benefits coverage (prior authorization) has been approved, the patient will be scheduled for an Inspire system implant

ScreeningSurgical

ConsultDISE

Insurance Prior Auth.

Implant



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Post Implant – Episode of Care Summary

A multi-disciplinary team consisting of an sleep physician and ENT

surgeon is responsible for therapy activation and long term care

follow up

Post-op CheckTherapy

ActivationPhone

CallSleep Study

Regular Follow Up

Sleep PhysicianSleep or ENT Surgeon



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What Post Implant Follow-up is Needed?

• The ENT surgeon should examine the incisions and healing process 7-10 days following implant– NOTE: Inspire therapy is still de-activated

• 1 month after implant, the physician will activate Inspire therapy for the first time

• 1 week following activation, the patient should be called to assess the acclimation process

• ~1 month after activation, the patient will undergo an in-lab sleep study titration to optimize Inspire therapy parameters

• Regular follow up visits are recommended every 6-12 months

Post-op CheckTherapy

ActivationPhone

CallSleep Study

Regular Follow Up



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Patient Follow Up With Inspire Therapy- Module 6 training will be conducted after the 1st implant -

Physician Tablet

Programmer Bag

The physician tablet allows the provider to:

– Program Inspire therapy settings wirelessly

– Monitor and track Inspire adherence

– Reporting capabilities & troubleshooting



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Patient Response Curves

16

OS

A S

eve

rity

Rapid, durable responder Slow-but-sure responder Partial-to-non responder

Implant /

Activation

2-3 Month

Titration1 Year Long Term

Curves are approximations

Most

patients

• Ideally centers should have 10 implanted patients followed at 6 months before assessing overall therapy effectiveness

• Some patients will require advanced titration methods• Regardless of curve the goal for all patients is “all night every night” usage

Therapy Implementation


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Therapy Outcome Drivers

• Patient selection

– BMI > 32

• Decreased likelihood of response

• Increased complexity of implant

– OSA type

• Greater than 25% central sleep apnea patients are not indicated

– DISE to screen out patients with CCC at the palate

• Sedation level is critical, must closely mimic sleep

• Electrode placement / implant technique

– Optimal tongue motion

– Minimal disruptive dissection of nerve and supporting structures

Therapy Implementation


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Section 2: Patient Introduction to Inspire

• Inspire therapy overview

• Good candidates for Inspire therapy

• Patient visit overview

• Inspire therapy questions and answers


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Patient Introduction to Inspire

19


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Inspire Therapy Overview

• Inspire therapy:– Works inside the body - fully implanted

– Monitors breathing patterns during sleep

– Delivers mild stimulation to key airway muscles to keep airway open while you are sleeping

– Turned on and off with a handheld sleep remote

20

Sleep Remote


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Therapy History

• Over 100,000 patients each year receive an implantable

neuro-stimulation system for various medical conditions

• Inspire therapy is a neuro-stimulation system for sleep

apnea and was developed at Medtronic

• Over 40 leading medical centers are currently qualified

and trained to treat patients with Inspire therapy


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How Does Inspire Therapy Work?

Inspire therapy keeps your airway open while you sleep


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Inspire Therapy – Sleep Study Illustration

Inspire OFF

A four minute snapshot while therapy is being turned on

Inspire ON

Airflow

Breathing

Effort

Oxygen

Severe OSA Airflow, breathing and normal oxygen

levels restored


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Inspire Therapy Performance Was Evaluated In The

STAR Clinical Trial

• 126 patients who struggled with CPAP received Inspire therapy

• Results were published in the New England Journal of Medicine

Results at 1 year:

• 86% of patients reported using the therapy every night

• On average, patients experienced a 70% decrease in their sleep apnea events

• 85% of patients showed improvement in their quality of life measures

• 85% of bed partners reported “no or soft snoring”

Sources:

• Upper-airway Stimulation for Obstructive Sleep Apnea, Strollo PJ Jr, Soose RJ, Maurer JT et al. N Eng J Med. 2014;370(2):139-149

• Inspire STAR clinical database

There were no unanticipated adverse events - only two events required surgical intervention. Both involved repositioning the

generator – procedures performed under local anesthesia.


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Inspire Therapy Patient Profile

• Diagnosed with obstructive sleep apnea (AHI 20-65)

• Struggle to get consistent benefit from CPAP

• Have a compatible airway anatomy profile

• Have a body mass index (BMI) ~32 or less


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Inspire Therapy Visits

Routine

Follow-ups

Sleep profile(May require a new sleep study)

Anatomy check(Requires a sedated endoscopy)

Typically

outpatient

Assessment ImplantAfter Implant

Therapy

activation

Therapy

optimization(Requires a sleep study)

Annual check up


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Inspire Therapy Surgery Overview

• Typically an outpatient procedure

– Most patients return to home the same day

– General anesthesia

• Three small incisions

– Expect some pain & swelling at the incision sites for a few days after

surgery

• Recovery time of ~ 2 weeks

– A return to normal non-strenuous activities occurs within a few days

– The surgeon will evaluate the healing process after one week

– Strenuous activity should be avoided for about two weeks

• Most patients take Tylenol for post surgery pain if needed


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How Do You Control Inspire Therapy?

• You have complete control of Inspire

therapy with your personal sleep remote:

– Turn Inspire ON or OFF

– Pause therapy

– Adjust the level of stimulation

• Each night, you use the sleep remote to

turn Inspire therapy on before going to

sleep and off when you wake up


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What Does Inspire Therapy Feel Like?

Stimulation Off

Mild

Stimulation

• Inspire therapy delivers

mild stimulation to key

airway muscles

• Patients describe feeling

a mild contraction or

tingling sensation in the

tongue when first

activating Inspire

therapy

• Therapy is adjustable for

patient comfort


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Starting with Inspire Therapy

• Most patients get used to Inspire

therapy within the first week

• Therapy levels can be adjusted by the

patient

• In the STAR trial, at 1 year follow-up,

86% of patients reported using Inspire

therapy every night


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Is Inspire Therapy Covered by Insurance?

• This approach has been successful and we are

committed to helping each patient with the

process

• You do not need to have prior approval from

your insurance company for the therapy before

your first clinic visit

• Inspire therapy is FDA approved and proven to be effective in

treating obstructive sleep apnea

• Currently, the therapy is reviewed and approved by insurance

companies on a patient by patient basis

• We will work with Inspire (the company which developed the

therapy) on your behalf to gain payment approval


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Will You Have Out of Pocket Expenses?

• Each insurance plan is different

• In general, the co-pay for Inspire therapy should be similar to co-pays for other surgical procedures

• You may also have secondary benefits or supplemental coverage that will offset your co-pay


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Incisions After Healing is Complete

Incision and device

under collar boneIncision on neck

for stimulation lead

Incision on chest

for sensor lead


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How Do Physicians Monitor & Program Inspire Therapy?

Physician Tablet

The physician tablet enables wireless communication and programming


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Common Questions About Inspire Therapy

• How long will the battery last?

• ~8-11 years

• Once the battery runs out, the generator

will be replaced with a routine procedure

• How often should a doctor check the

Inspire system?

• The system should be checked 1-2

times per year


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Common Questions About Inspire Therapy

• Are there any medical technologies

that should be avoided?

– MRI scanners may cause harm to

components of the Inspire system and

may also cause tissue damage. Other

imaging technologies like CT-scan and

ultrasound are safe to use.

• How about microwave ovens and other

common household appliances?

– Any common household appliances that

do not emit a strong magnetic field are fine


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As with any surgically implanted device, there are risks associated with the Inspire

system. First, there are risks related to the surgical procedure itself such as pain,

swelling, temporary tongue weakness, and infection. These types of events are

risks with any kind of surgery, and almost all of them resolve on their own or with

medication within a period of weeks or months.

Once the therapy is turned on, some patients may experience discomfort from

stimulation, tongue abrasion, mouth dryness, and discomfort from the presence of

the device. The majority of these events resolve either on their own, with

medication, or by adjusting the therapy settings. Inspire therapy may not work for

everyone. Your doctor may need to take additional steps to address your sleep

apnea.

Patients with Inspire therapy will not be able to have an MRI. Other imaging

modalities are OK.

Risk Considerations


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Patient Education Materials

38

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www.InspireSleep.com

introduction to inspire therapy - ear, nose, throat & plastic surgery associates

Health & Medicine

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