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Evaluation of Trends in the US ICD Market Following Recent Events By: MedPanel, Inc.

Evaluation of Trends in the US ICD Market Following Recent Events By: MedPanel, Inc. February 2006. Study Objectives. Primary Objective: To assess the changes in ICD market based on recent issues and events. Specific Objectives include:

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Evaluation of Trends in the US ICD Market Following Recent Events By: MedPanel, Inc.

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  1. Evaluation of Trends in the US ICD Market Following Recent EventsBy: MedPanel, Inc. February 2006

  2. Study Objectives Primary Objective: To assess the changes in ICD market based on recent issues and events. • Specific Objectives include: • To understand the impact of performance issues and recalls in the past year; • To determine past and expected future usage trends; • To identify current company perceptions; • To evaluate impact of Boston Scientific’s acquisition of Guidant

  3. Methodology and Sample • Survey Specifics: • A 10-minute self-administered survey was fielded online via MedPanel’s website from February 5 – February 9, 2006. • Sample: • The total sample consists of 50 Electrophysiologists from across the US: • To qualify, respondents were required to meet the following criteria: • Board certified or board eligible in electrophysiology • Have been in practice between 2 and 30 years • Spend at least 75% of their professional time in clinical practice • Perform 10 ICD implants per month

  4. Respondent Practice Background Respondent Practice Background Practice Location (n=50) Years in Practice: Range: 2-25 Average: 11.0 Time in Clinical Practice: Range: 75-100% Average: 91.9% Mean # of ICD implants per month: Range: 10-50 Average: 17.1

  5. Summary of Key Findings • Reaction to Product Recalls • Despite patient safety concerns due to ICD performance issues and recalls there does not appear to be a significant effect on overall referral patterns for the majority of electrophysiologists. • 94% of electrophysiologists indicated that patients are more concerned about ICD safety. • 66% of electrophysiologists indicate that the performance issues and recalls have had no impact on patient referrals over the past 12 months. • ICD Implant Volume • Over three quarters of the electrophysiologists saw an increase in their initial and replacement ICD implant volume in 2005 as compared to 2004. • Expectation of implant volumes for 2006 vary by procedure: • 76% expect to see increased volume in their initial implant procedures. • However, only 38% expect to see increased volume in their replacement ICD procedures.

  6. Summary of Key Findings • ICD Product Comparisons • Medtronic received the highest overall scores for ICD product quality, sales support quality and corporate integrity. • Guidant received the lowest scores in all three categories. • Impact of Boston Scientific Acquisition of Guidant • Most electrophysiologists do not feel that the acquisition will change their overall opinion of Guidant’s CRM business. • However, about one-quarter of electrophysiologists do feel that the acquisition will positively impact their opinion. • Approximately one-third of electrophysiologists expect product quality, manufacturing integrity and sales support to improve under ownership by Boston Scientific.

  7. Summary of Key Findings • Product Mix • Electrophysiologists most commonly used Medtronic ICDs in 2005 and that trend continues today. • Medtronic ICDs currently hold about 50% market share. • Guidant lost ground to both Medtronic and St. Jude in 2005. • In the first half of 2007, Medtronic is still expected to have the largest share followed by Guidant and St. Jude. • Guidant is expected to make up a portion of the losses from last year.

  8. Detailed Summary of Findings

  9. Impact of Performance Issues Two-thirds of electrophysiologists indicted that the recent performance issues and recalls have had no impact on their patient referral patterns. However, the vast majority of electrophysiologists report that patients are more concerned about defibrillator therapy. Patient Referral Patterns Following ICD Recalls (n=50) Impact on Patients’ View of Defibrillator Therapy (n=50) Q1. Have the ICD performance issues and recalls of the last 12 months (Medtronic Marquis, Guidant Prizm, Renewal, etc) impacted patient referral patterns to your practice for ICD therapy? Q2. What about the impact on the patients’ view of defibrillator therapy?

  10. Trend in Implant Volume Over 80% of electrophysiologists indicated that their initial ICD implant volume increased in 2005 as compared to 2004. The average increase in volume was nearly 25%. Initial ICD Implant Volume -2005 vs. 2004- (n=50) n=41 Mean increase in volume = 24% (range: 3-100%) n=4 Mean decrease in volume = 21% (range: 15-30%) Q3a. How did your ICD initial implant volume in 2005 (not including replacements) compare with your initial implant volume in 2004?

  11. Trend in Implant Volume Approximately three-quarters of electrophysiologists expect that their initial ICD implant volume will increase in 2006 as compared to 2005. The average expected increase in volume is 16%. Initial ICD Implant Volume -2006 vs. 2005- (n=50) n=38 Mean increase in volume = 16% (range: 3-50%) n=4 Mean decrease in volume = 16% (range: 10-25%) Q4a. How do you expect your ICD initial implant volumes for 2006 will compare with 2005?

  12. Trend in Implant Volume Approximately three quarters of electrophysiologists indicated that their replacement ICD implant volume increased in 2005 as compared to 2004. The average increase in volume was nearly 25%. Replacement ICD Implant Volume -2005 vs. 2004- (n=50) n=38 Mean increase in volume = 24% (range: 10-50%) n=2 Mean decrease in volume = 15% (range: 10-20%) Q3b. How did your replacement ICD implant volume for 2005 compare with replacement volume during 2004?

  13. Trend in Implant Volume Only about 40% of electrophysiologists expect that their replacement ICD implant volume will increase in 2006 as compared to 2005. The average expected increase in volume is 13%. Replacement ICD Implant Volume -2006 vs. 2005- (n=50) n=19 Mean increase in volume = 13% (range: 5-30%) n=8 Mean decrease in volume = 18% (range: 10-30%) Q4b. What are your replacement ICD implant volume expectations for 2006 compared with 2005?

  14. ICD Product Comparisons In general, ratings for ICD product quality were positive across the three manufacturers. Overall, Medtronic received the highest ratings for quality while Guidant received the lowest ratings. ICD Product Quality (n=50) Poor Quality High Quality Q5. Please rate overall ICD product quality, on a scale of 1-5, for the following manufacturers:

  15. ICD Product Comparisons On average, all manufacturers received high ratings for the quality of their sales support. Medtronic received the best ratings overall while Guidant was rated lowest. Sales Support Quality (n=50) Excellent Poor Q6. Please rate the quality of sales support, on a scale of 1-5, for the following ICD manufacturers:

  16. ICD Product Comparisons Medtronic and St. Jude received positive ratings for corporate integrity, while Guidant was perceived more negatively. Corporate Integrity (n=50) Highest Lowest Q7. Please indicate your view of corporate integrity, on a scale of 1-5, for the following ICD manufacturers:

  17. Boston Scientific Acquisition About one in four electrophysiologists indicated that the acquisition of Guidant by Boston Scientific would have a positive impact on their opinion of Guidant’s CRM business. Likewise, about one in three expect that the acquisition will improve Guidant’s product quality, manufacturing integrity and sales support. Impact of Boston Scientific Acquisition of Guidant (n=50) Impact on Guidant Perceptions (n=50) Q8a. Do you think the acquisition of Guidant by Boston Scientific would positively or negatively impact your opinion of Guidant’s CRM business? Q8b. Under the Boston Scientific umbrella, do you expect product quality, manufacturing integrity, and sales support to improve at Guidant?

  18. Boston Scientific Acquisition While 20% of electrophysiologists are likely to increase use of Guidant products after the acquisition, the majority (72%) indicated that they are not likely change their use. Impact of Boston Scientific Acquisition of Guidant on Usage (n=50) Q8c. Finally, would the acquisition of Guidant by Boston Scientific make you more or less likely to use the company’s devices?

  19. ICD Usage In the first half of 2005, Medtronic ICDs and CRT-Ds were used most commonly. Guidant devices were used slightly less often while use of St. Jude devices lagged far behind the other two manufacturers. ICD Usage -First Half of 2005- (n=50) Q9. One year ago (first half of 2005), what do you think your product mix was for (a) all ICD implants and then (b) just CRT-D devices?

  20. ICD Usage Currently, Medtronic ICDs and CRT-Ds are used by the majority of electrophysiologists and are used approximately twice as much as devices from the other manufacturers. ICD Usage -Current- (n=50) Q10. How would you describe your current product mix for (a) all ICD implants and then (b) just CRT-D?

  21. ICD Usage In the first half of 2007, Medtronic ICDs and CRT-Ds are expected to be used by approximately 50% of electrophysiologists. Guidant devices will be used more commonly than those made by St. Jude, but both fall far behind Medtronic. ICD Usage -First Half of 2007- (n=50) Q11. One year from now (first half of 2007), what do you anticipate your product mix will be?

  22. ICD Usage In 2005, Guidant experienced a relative decline to both Medtronic and St. Jude in product usage. By 2007, electrophysiologists expect Guidant to make a slight comeback.

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