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HeartStart Home OTC Defibrillator FDA Panel Presentation

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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HeartStart Home OTC Defibrillator FDA Panel Presentation

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  1. HeartStart Home OTC DefibrillatorFDA Panel Presentation

  2. Introduction • Carl Morgan • Company Co-Founder and Scientist P 2

  3. We propose to remove the prescription requirement for the Philips HeartStart Home Defibrillator. Introduction to today’s discussion P 3

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Product overview • David Snyder • Director of Research, Philips P 11

  12. 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

  13. Demonstration P 13

  14. 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

  15. History of Philips AED technology P 15

  16. 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

  17. 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.

  18. 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

  19. 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

  20. MDR summary—ForeRunner and FR2 Top 3 issues and predominant causes, confirmed & unconfirmed P 20

  21. HeartStart Home DefibrillatorDesign features relevant to top 3 ForeRunner and FR2 MDR issues P 21

  22. First-year annualized failure rate for Philips defibrillators (all causes) P 22

  23. Automated self-test P 23

  24. Iterative design process P 24

  25. 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

  26. Philips HeartStart Home Defibrillator • Designed as safety equipment. • History of safety and readiness. • Designed for ease of use. P 26

  27. Clinical overview Safety and usability study • Dr. Lance Becker • Professor of Medicine, University of Chicago • Disclosures P 27

  28. 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.

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. FR2 results: Simulated-use test P 38

  39. FR2 results: Time-to-shock P 39

  40. HeartStart Home results: Simulated-use test P 40

  41. HeartStart Home results: Time-to-shock P 41

  42. Study limitations • Simulated use vs. reality • Demographics • Human anatomy more varied P 42

  43. 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

  44. Labeling evaluation and simulated use Lay user surveyPost-market study • David Snyder • Director of Research, Philips P 44

  45. 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

  46. Secondary labeling materials P 46

  47. 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

  48. 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

  49. 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

  50. 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

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