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HeartStart Home OTC Defibrillator FDA Panel Presentation. Introduction. Carl Morgan Company Co-Founder and Scientist. P 2. We propose to remove the prescription requirement for the Philips HeartStart Home Defibrillator. Introduction to today’s discussion. P 3.

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Presentation Transcript
introduction
Introduction
  • Carl Morgan
    • Company Co-Founder and Scientist

P 2

we propose to remove the prescription requirement for the philips heartstart home defibrillator
We propose to remove the prescription requirement for the Philips HeartStart Home Defibrillator.

Introduction to today’s discussion

P 3

slide4
HeartStart Home Rx cleared in 2002

Rx requirement:

“CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.”

P 4

improving access to help save lives
Improving access to help save lives
  • Mission
    • Prevent unnecessary deaths due to sudden cardiac arrest.
  • Focus
    • Improving access by developing and deploying automated external defibrillators (AEDs) that can be used by virtually anyone to help save a life.

P 5

timeline
Timeline
  • Heartstream founded 1992
  • ForeRunner launched 1996
  • First save on American Airlines 1998
  • Initial discussions with the FDA re: OTC 1999
  • FR2 launched 2000
  • Filed pre-IDE 2001
  • HeartStart Home Defibrillator launched 2002
  • Filed 510(k) for OTC clearance 2004

P 6

medical device labeling
Medical device labeling

The Food, Drug and Cosmetic Act requires that medical device labeling must bear “adequate directions for use…”(502 (f)(1))

“directions under which the layman can use a device safely and for the purposes for which it is intended.” (21CFR§801.5)

P 7

the prescription caution
The prescription caution

A prescription caution must be included in labeling if a device:

“…is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which ‘adequate directions for use’ cannot be prepared.”

(21CFR§801.109)

P 8

basis for removing the rx requirement for the heartstart home defibrillator
Basis for removing the Rx requirement for the HeartStart Home Defibrillator
  • Demonstrate established history of safe use.
  • Demonstrate that the HeartStart Home Defibrillator can be used safely and for its intended purpose based upon its labeling alone.

P 9

presenters
Presenters
  • David Snyder
    • Director of Research, Philips
  • Dr. Lance Becker
    • Professor of Medicine
    • Director, Emergency Resuscitation Center, University of Chicago
  • Dr. Jeremy Ruskin
    • Founder and Director, Cardiac Arrhythmia Service and Clinical Electrophysiology Laboratory, Massachusetts General Hospital
    • Arrhythmia research

P 10

product overview
Product overview
  • David Snyder
    • Director of Research, Philips

P 11

philips heartstart home defibrillator
Philips HeartStart Home Defibrillator
  • Received FDA clearance in November 2002.
  • Indications for use:
    • Unresponsive or not breathing normally.
    • If in doubt, apply pads.
  • Safety and effectiveness already established.

P 12

designed as safety equipment
Designed as safety equipment
  • “If you have concerns about your health or an existing medical condition, talk to your doctor. A defibrillator is not a replacement for seeking medical care.”
  • Cannot predict who might need it, or when.
  • Equipment may be used once in a lifetime.
  • Key characteristics:
    • Safe for all
    • Ready when needed
    • Easy in the moment

P 14

sophisticated arrhythmia detection
Rapidity of

signal conduction

  • ECG
  • amplitude

Heart rate

Stability of ECG

complexes

Sophisticated arrhythmia detection
  • No single parameter can lead to “shock advised.”
  • Multiple parameters required.

P 16

field demonstrated sensitivity specificity
Field-demonstrated sensitivity/specificity
  • Biphasic waveform study
    • 1st generation AED--ForeRunner
    • 286 out-of-hospital patients (1st 100 VF)
    • 100% sensitivity, 100% specificity
  • American Airlines study
    • 1st generation AED--ForeRunner
    • 200 consecutive uses; 15 VF patients
    • 100% sensitivity, 100% specificity
    • Includes use as a rhythm monitor
      • Tens of thousands of analyses
  • One known inappropriate shock.
    • Successful defibrillation, followed by AF with no ventricular activity; indistinguishable from fine VF. Patient survived with normal neurological function.

P 17

Gliner et al., Biomed Instrum Technol. 1998;32(6):631-643.

Page et al., N Eng J Med. 2000;343:1210-1216.

philips aed use estimates through 12 31 2003
Philips AED use estimates Through 12/31/2003
  • Over 150,000 AEDs deployed since 1996.
  • > 1,000,000 total patient applications.
    • ~ 200,000 patients required shocks.
    • ~ 800,000 patients did not require shocks.
  • Non-random sampling based on ForeRunner AEDs.

P 18

field performance
Field performance
  • Six confirmed AED emergency use failures across Philips installed base (> 1,000,000 patient applications).
    • 4 no patient impact
    • 1 patient impact indeterminate
    • 1 possible patient impact
  • No complaints about shock effectiveness.

P 19

mdr summary forerunner and fr2 top 3 issues and predominant causes confirmed unconfirmed
MDR summary—ForeRunner and FR2 Top 3 issues and predominant causes, confirmed & unconfirmed

P 20

heartstart home defibrillator design features relevant to top 3 forerunner and fr2 mdr issues
HeartStart Home DefibrillatorDesign features relevant to top 3 ForeRunner and FR2 MDR issues

P 21

first year annualized failure rate for philips defibrillators all causes
First-year annualized failure rate for Philips defibrillators (all causes)

P 22

heartstart home life cycle support
HeartStart Home life-cycle support

Storage & Maintenance

Post-Use

Use

Training

Purchase

Set-Up

Product Packaging

HeartStart Home Defibrillator

Primary labeling—Voice Prompts, Device Icons, Self-Test

Sales Materials

HeartStart Home Defibrillator

Secondary labeling—Quick Reference, Owner’s Manual, Training Video, Quick Start, Training Coupons, Product Registration Card

  • Product Website
  • Resources
  • FAQs

Philips Customer Service

Product Information, Training Resources, Consumables, Data Retrieval, Grief Counseling, Physician Access

P25

philips heartstart home defibrillator26
Philips HeartStart Home Defibrillator
  • Designed as safety equipment.
  • History of safety and readiness.
  • Designed for ease of use.

P 26

clinical overview safety and usability study
Clinical overview Safety and usability study
  • Dr. Lance Becker
    • Professor of Medicine, University of Chicago
  • Disclosures

P 27

sudden cardiac arrest a leading killer in the united states
Sudden Cardiac Arrest: A leading killer in the United States
  • Majority have no prior symptoms.
  • Nearly 80% happen in the home.
  • More than 50% of home arrests witnessed.

P 28

American Heart Association. Heart Disease and Stroke Statistics — 2004 Update. Dallas, Tex.: American Heart Association; 2003.

Litwin et al., Ann Emerg Med. 1987;16:787-791.

slide29
American Heart Association. Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Dallas, Texas: American Heart Association, 2000.

Cummins et al., Circulation. 1991;83:1832-1847.

P 29

slide30
Time is key to survival

Response curve (exponential decay rate) is after: De Maio et al., Ann Emerg Med. 2003;42:242-250.

Time intervals after Herlitz et al., Eur Heart J 2003;24:1750-5. Blackwell et al., Academic Emerg Med. 2002;9:288-295., Braun et al., Ann Emerg Med. 1990;19:1058-64., White et al., Resuscitation. 2002Oct;55(1):17-23., Myerburg et al., Circulation. 2002;106:1058-1064.

P 30

slide31
Early access can help save more lives

Response curve (exponential decay rate) after: De Maio, et al. Ann Emerg Med. 2003;42:242-250.

P 31

early defibrillation programs
Early defibrillation programs

Page et al., N Eng J Med. 2000;343:1210-1216.

Caffrey et al., N Eng J Med. 2002;347:1242-1247.

Valenzuela et al., N Eng J Med. 2000;343:1206-1209.

P 32

nhlbi sponsored public access defibrillation pad trial will aeds improve survival
NHLBI-sponsored Public Access Defibrillation (PAD) trial: Will AEDs improve survival?
  • Study objective — Will AEDs improve cardiac arrest survival compared with CPR alone?
    • 20,000 lay responders in facilities with a pre-defined risk of an event.
  • Results
    • Survival in CPR+AED group doubled (n=29) compared with CPR alone (n=15).
    • No serious adverse events associated with AED use.
    • 89.3% of evaluated responders (n = 3,671) demonstrated “adequate” AED skills 3 months after training.*
  • Conclusion
    • Laypersons can use AEDs safely to provide early defibrillation.

Ornato J. AHA Scientific Sessions 2003.

*Sehra et al., (Abstract 2002);Suppl to Circulation, Vol 106, No 19, pg II-403.

P 33

rapid response saves lives
Rapid response saves lives
  • Time is critical — Early defibrillation is highly effective.
  • Primary question — Can the HeartStart Home Defibrillator be used safely by lay people?

P 34

safety and usability study
Safety and usability study
  • Hypothesis #1
    • The Philips HeartStart Home Defibrillator and FR2 are safe – even in the absence of training.
  • Hypothesis #2
    • The HeartStart Home and FR2 have high usability when used with primarylabeling components(voice prompts, product graphics) plus training video.
  • Study method
    • Mock cardiac arrest scenario with a fully dressed manikin and AED.

P 35

enrollment and randomization
Randomization

Randomization

Enrollment and randomization

FR2

HeartStart Home

HeartStart Naïve

n = 62

Simulated Use Test

Simulated Use Test

Powered to detect a 20% difference between naïve and video trained for

each device with power = 0.80 and alpha = 0.05 (approx. 62 per group).

P 36

primary and secondary endpoints
Primary and secondary endpoints
  • Primary endpoints
    • Safe: no touching of patient in a manner that could result in a shock across the rescuer’s chest.
    • Successful: shock delivered with pads positioned in a manner likely to defibrillate (includes power on, attach pads with appropriate pad placement, analyze, and defibrillate within 5 min).
  • Secondary endpoints (based on starting time from when participant entered the room).
    • Time-to-pads on
    • Time-to-shock

P 37

study limitations
Study limitations
  • Simulated use vs. reality
  • Demographics
  • Human anatomy more varied

P 42

conclusions
Conclusions
  • The HeartStart Home Defibrillator and the FR2 were used safely in all cases (n = 132, 124 respectively).
  • FR2 success rate significantly improved by video training from 48% to 86% (p < 0.001).
  • HeartStart Home Defibrillator successfully used by both naïve and video trained volunteers at 87% (79% LCL, n = 61) and 89% (81% LCL, n = 63) with no difference detected between naïve and video trained.

P 43

labeling evaluation and simulated use lay user survey post market study
Labeling evaluation and simulated use Lay user surveyPost-market study
  • David Snyder
    • Director of Research, Philips

P 44

labeling evaluation and simulated use purpose
Labeling evaluation and simulated usePurpose
  • Labeling evaluation: Test comprehension of secondary labeling materials for the Philips HeartStart Home OTC Defibrillator.
    • Owner’s Manual
    • Quick Reference
    • Training Video
    • Quick Start Poster
  • Simulated use: Demonstrate safe and successful use after review of only one component of labeling.
    • Owner’s Manual
    • Quick Reference

P 45

methods
Methods
  • Recruitment in 3 geographically diverse shopping malls.
  • No medical or defibrillator training, no CPR training within 2 years.
  • Age range 21-74.

P 47

methods48
Methods
  • Hypothesis for comprehension test:
    • The written labeling materials are well understood.
    • Approximately 90% passing grade (LCL > 80%).
  • Hypotheses for simulated use:
    • The HeartStart Home Defibrillator is safe.
    • The HeartStart Home Defibrillator can be successfully used by laypersons to deliver a defibrillation shock.
    • Non-inferiority vs. 90% (10% margin).
  • Study method
    • Mock cardiac arrest scenario with a fully dressed manikin and AED

P 48

enrollment and randomization49
Randomized

Randomized

Stratified

Enrollment and randomization

30 min

15 min

Simulated use powered for a non-inferiority delta of 10% versus presumed success rate of 90% with power = 0.80 and alpha = 0.05.

Comprehension sample size determined to establish 95% LCL of 80% for presumed success rate (C grade or better) of 90%.

Simulated Use Test

P 49

primary and secondary endpoints50
Primary and secondary endpoints
  • Primary endpoints
    • Safe: no touching of patient in a manner that could result in a shock across the rescuer’s chest.
    • Successful: shock delivered with pads positioned in a manner likely to defibrillate (includes power on, attach pads with appropriate pad placement, analyze, and defibrillate within 5 min).
  • Secondary endpoints (based on starting time from when participant entered the room).
    • Time-to-pads on
    • Time-to-shock

P 50

comprehension test
Comprehension test
  • Written labeling materials at a 6th grade reading level or lower (Flesch-Kincaid).
  • Test topics included:
    • Definition of SCA (vs. MI, stroke, etc.)
    • Set-up
    • Training
    • Storage
    • Maintenance
    • When to use defibrillator
    • Rescue steps
    • Post-shock care
    • Infant/child use

P 51

limitations and conclusions
Limitations and conclusions
  • Study limitations same as safety and usability study.
  • All labeling well understood with at least 90% receiving a “passing” grade. Passing grade LCL ≥ 88% for all tests.
  • Defibrillator used safely in all cases (n = 178).
  • Successful use 97% (92% LCL, n = 89) with Quick Reference.
    • Recommended labeling for emergency response.

P 55

follow up
Follow-up
  • Added information to training video and Quick Start poster regarding intended use of various labeling materials.
  • Cover of Owner’s Manual modified to clarify its purpose as a guide to set up, maintenance, and accessories.

P 56

lay user survey purpose
Lay user survey–Purpose
  • Determine if lay use of Philips AEDs results in any previously unreported problems.

P 57

Jorgenson et al., Resuscitation. 2003;59:225-233.

lay user survey methods
Lay user survey–Methods

Owned AED at least 1 year

Medical professionals excluded

Lay users identified

145 homes 2,683 businesses and public facilities

Initial contact by phone center (at least 7 contact attempts)

Brief interview Use by layperson?

Yes—Use by a layperson

Detailed interview with medical professional

P 58

lay user survey results
Lay user survey–Results
  • Surveyed 78 homes and 1,645 businesses.
    • No problems reported.
    • 209 businesses (13%) had used an AED at least once.
    • 9 uses in homes/home offices.
  • Conducted 11 detailed interviews regarding pads applied to unresponsive patients.
    • EMS called in all cases.
    • 3 patients appropriately received no shocks.
    • 8 patients received shocks.
      • 6 survived to hospital admission.
      • 4 received shocks solely from lay responders, and all survived to hospital admission.

P 59

lay user survey limitations and conclusions
Lay user survey–Limitations and conclusions
  • Limitations—Survey and interview participation was voluntary.
  • Conclusions
    • No harm or injury to users, bystanders or patients.
    • No malfunctions or problems.
    • All users willing to use defibrillator again.
    • No safety or effectiveness issues reported.

P 60

ongoing heartstart home post market study purpose
Ongoing HeartStart Home post-market studyPurpose
  • Evaluate lay uses of HeartStart Home Defibrillator for safe and appropriate application.

P 61

methods62
Methods

Contact lists generated:

HeartStart Home owned > 1 year

or 1 year since last surveyed

Pads re-ordered or use

reported to Philips

AEDused?

Contact owner

Detailed interviewwith medical professional

Yes

P 62

proposed extension to heartstart home post market study
Proposed extension to HeartStart Home post-market study
  • Extend ongoing post-market study to 200 home uses total or 4 years from HeartStart Home OTC Defibrillator clearance.
  • Results to be reviewed by DSMB and reported annually to FDA.

P 63

clinical perspective
Clinical perspective
  • Dr. Jeremy Ruskin
    • Director, Cardiac Arrhythmia Service, Massachusetts General Hospital
  • Disclosures

P 64

sudden death risk stratification
Sudden death - Risk stratification

"High-Risk" Pts

Survivors

VT-VF

Prior MI

LV Dysfxn

CHF

VEA

+EPS

50%

65%

50%

50%

65%

P 65

Ruskin et al., NEJM. 1980;303:607-613.

Wilber et al., NEJM. 1988;318:19-24.

sudden death risk stratification66
Undetected

High-Risk

Patient Pool

Sudden death–Risk stratification

"High Risk" Pts

Survivors

VT-VF

Prior MI

LV Dysfxn

CHF

VEA

+EPS

50%

65%

50%

50%

65%

P 66

Ruskin et al., NEJM. 1980;303:607-613.

Wilber et al., NEJM. 1988;318:19-24.

safety equipment
Air bags

HeartStart Home

Defibrillator

Seat belt

Safety equipment

Smoke alarm

Fire extinguisher

P 68

benefits and limitations
Benefits and limitations

Ahrens, M. U.S. experience with smoke alarms and other alarm devices, Nov 2003, National Fire Protection Association, Fire Analysis and Research Division, 1 Batterymarch Park, Quincy, MA 02169-7471

 National Highway Safety Administration, Air Bag Facts, Safety Fact Sheet, 11/02/1999 http://www.nhtsa.dot.gov/airbags/factsheets/numbers.html

P 69

sca and motor vehicle injury deaths in us 1999
SCA and motor vehicle injury deaths in US (1999)

P 70

State-Specific Mortality from Sudden Cardiac Death--- United States, 1999. CDC, MMWR, February 15, 2002/ 51(06); 123-6

10 Leading Causes of Unintentional Injury Deaths, United States, 1999, All Races, Both Sexes. CDC Website

10 year expectations for emergency events
10-year expectations for emergency events
  • U.S. Experience with Smoke Alarms and other Fire Alarms, Ahrens, Fire Analysis and Research Division, National Fire Protection Association, Nov 2003.
  • Projections of the Number of Households and Families in the United States: 1995 to 2010, P25-1129, US Dept of Commerce, Bureau of the Census, April 1996.
  • How Many Homes Are There? US Census Bureau, American Housing Survey, http://www.census.gov/hhes/www/housing/ahs/01dtchrt/tab2-1.html.
  • Safety Fact Sheet, National Highway Traffic Safety Administration, 11/2/99, http://www.nhtsa.dot.gov/airbags/factsheets/numbers.html.
  • ZJ Zheng, et al, State-Specific Mortality from Sudden Cardiac Death-- United States, 1999. MMWR Weekly, CDC, Feb 15, 2002/ 51(06); 123-6.

P 71

benefits of removing the rx requirement
Benefits of removing the Rx requirement
  • Broader access to a safe and effective technology that is the only definitive treatment for SCA.
  • Provide an opportunity to save some of the lives that would otherwise be lost to SCA.

P 72

risks can the aed cause harm
Risks—Can the AED cause harm?
  • HeartStart Home OTC is the same intended user and patient population as Rx.
  • Robust safety features.
    • ECG analysis system
    • Artifact detection
    • No manual override

P 73

philips aed field performance
Philips AED field performance
  • > 1,000,000 total patient applications.
    • ~ 200,000 patients required shocks.
    • ~ 800,000 patients did not require shocks.
  • One known inappropriate shock.
  • No complaints about shock effectiveness.

P 74

summary
Summary
  • Safe design and establishedhistory of safe use.
  • The HeartStart Home Defibrillator can be used safely and for its intended purpose based upon its labeling alone.

P 75

theoretical risks
Theoretical risks
  • Will OTC AEDs interfere with medical care?
    • Not a substitute for medical care.
    • Risk factors still need to be addressed.
    • Care and prescribed therapies for pre-existing conditions need to continue.
    • Physicians retain option to prescribe AEDs in cases of medical necessity.
    • Target populations are different.
  • Will OTC defibrillators interfere with EMS response?
    • SCA survival rate is <5% because defibrillators do not arrive in time.
    • Philips supports calling EMS in labeling.
      • Early defibrillation one part of emergency response.
    • Rx requirement does not enhance EMS response.

P 76

heartstart home defibrillator realistic expectations
HeartStart Home Defibrillator: Realistic expectations
  • SCA is an epidemic and a major public health problem; the most common cause of death in adults.
    • Survival rates are abysmally low (<5%).
  • A defibrillator is not a “cure” for the problem of SCA.
    • Unwitnessed arrests, devices used incorrectly, device failure, other human and logistical factors.

P 77

heartstart home defibrillator realistic expectations78
HeartStart Home Defibrillator: Realistic expectations
  • OTC defibrillators represent a paradigm shift and a step toward wider access.
    • Potential to save some lives that would otherwise be lost.
  • Long term: even a small impact could double current survival rates.

P 78

strategies for addressing sca
Strategies for addressing SCA
  • Prevention of coronary artery disease.
  • Revascularization and ICDs in high-risk patients.
  • Availability of on-site rapid defibrillation.

P 79

slide80
“Successful defibrillation depends on immediate recognition of the emergency and prompt application of the external defibrillator.”

Paul M. Zoll, M.D. 1956

P 80

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