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  1. 1. Usage of SilverHawk and MiniHawk Catheters for Peripheral Atherectomies Intelligence Report By MedPanel, Inc. September 2006
  2. 2. <ul><li>Contents </li></ul><ul><li>Study Objectives 2 </li></ul><ul><li>Methodology & Sample 3 </li></ul><ul><li>Respondent Background Information 4 </li></ul><ul><li>Executive Summary 5 - 9 </li></ul><ul><li>Detailed Findings 10 - 52 </li></ul>
  3. 3. Study Objectives Primary Objective: <ul><li>Specific Objectives: </li></ul><ul><li>Understand the current landscape of the peripheral atherectomy market </li></ul><ul><li>Assess current usage and perceptions of the SilverHawk catheters </li></ul><ul><li>Determine expected future use and trends for SilverHawk catheters </li></ul><ul><li>Gauge current usage and perceptions of the MiniHawk catheters </li></ul><ul><li>Determine expected future use and trends for MiniHawk catheters </li></ul><ul><li>Determine expected future use and trends for stent in PAD procedures </li></ul><ul><li>Measure physician awareness of the new technologies in PAD treatment </li></ul>Understand current usage and expected trends in usage of SilverHawk and MiniHawk catheters for peripheral atherectomies
  4. 4. Methodology and Sample <ul><li>Survey Specifics: </li></ul><ul><li>A 20-minute self-administered survey was fielded online via MedPanel’s Web site from September 5 - September 13, 2006. </li></ul><ul><li>Sample: </li></ul><ul><li>The sample comprised 26 interventional cardiologists and 29 vascular surgeons </li></ul><ul><ul><li>Physicians were selected from across the U.S. </li></ul></ul><ul><li>To qualify, respondents were required to meet the following criteria: </li></ul><ul><ul><ul><li>Primary specialty in interventional cardiology or vascular surgery </li></ul></ul></ul><ul><ul><ul><li>In practice between 2 and 30 years </li></ul></ul></ul><ul><ul><ul><li>Spend greater than 70% of their time in clinical practice </li></ul></ul></ul><ul><ul><ul><li>Currently see at least 50 patients/year with peripheral vascular disease </li></ul></ul></ul><ul><ul><ul><li>Perform interventional procedures in peripheral arteries </li></ul></ul></ul><ul><ul><ul><li>Currently perform or plan to perform peripheral atherectomies this year </li></ul></ul></ul>
  5. 5. Respondent Background S2. How many years have you been in practice, not including your residency or any fellowships? S3. What percent of your professional time is dedicated to clinical practice? S4. Please indicate the setting where you spend the majority of your clinical time. S5. Approximately how many patients per year do you see with peripheral vascular disease? Primary Practice Setting - Interventional Cardiologists- (n=26) Primary Practice Setting - Vascular Surgeons- (n=29) Interventional Cardiologists Mean Range 969 (100 – 3,000) 97 (80 – 100) 12.5 (5 – 25) 447 (50 – 1,000) Number of patients with peripheral vascular disease 95 (80 – 100) Percentage of time in clinical practice 9.6 (2 – 20) Years in practice Vascular Surgeons Mean Range
  6. 6. Executive Summary
  7. 7. Executive Summary <ul><li>Current Practices for PAD Treatment – Leg Atherectomies </li></ul><ul><ul><li>Interventional cardiologists currently perform about 7 peripheral atherectomy procedures per month. </li></ul></ul><ul><ul><li>Vascular surgeons currently perform about 6 peripheral atherectomy procedures per month. </li></ul></ul><ul><ul><li>Vascular surgeons most commonly perform leg atherectomies in the superficial femoral artery. Interventional cardiologists perform these procedures in the illiac artery and common and superficial femoral arteries almost equally. </li></ul></ul>
  8. 8. Executive Summary <ul><li>SilverHawk Usage and Perceptions </li></ul><ul><ul><li>Interventional cardiologists and vascular surgeons expect the increase in use of SilverHawk by 3-4 procedures in the next 6 months. </li></ul></ul><ul><ul><li>On average about 50% of interventional cardiologists and vascular surgeons indicate an increase in the use of SilverHawk in the past six months. </li></ul></ul><ul><ul><li>On average 50 % of interventional cardiologists and vascular surgeons indicate an increase in the use of SilverHawk in the next six months. </li></ul></ul><ul><ul><li>Interventional Cardiologists have a very positive impression of SilverHawk catheters. </li></ul></ul><ul><ul><ul><li>Interventional cardiologists primarily use SilverHawk in the superficial femoral, common femoral, and illiac arteries. </li></ul></ul></ul><ul><ul><li>Vascular surgeons have a more mixed impression of SilverHawk catheters. </li></ul></ul><ul><ul><ul><li>Vascular surgeons primarily use SilverHawk in the superficial femoral and popliteal arteries. </li></ul></ul></ul><ul><ul><li>Very few of the surveyed physicians were aware of any long-term data related to use of SilverHawk while rating highly the importance of the long-term data of the device. </li></ul></ul>
  9. 9. Executive Summary <ul><li>MiniHawk Usage and Perceptions </li></ul><ul><ul><li>Physicians generally were not familiar with MiniHawk but indicate an overall positive impression with the device. </li></ul></ul><ul><ul><li>Most commonly, physicians indicate they have better access to smaller vessels as major strengths of the MiniHawk. Weaknesses: MiniHawk’s small size and lack of long-term success. </li></ul></ul><ul><ul><li>Interventional cardiologists and vascular surgeons cite tibial vessel procedures and below-knee procedures as the most frequent types of lower extremity cases for which MiniHawk is utilized. </li></ul></ul><ul><ul><li>Vascular surgeons and interventional cardiologists currently use MiniHawk for approximately 14% of their peripheral (lower extremity) atherectomies. </li></ul></ul><ul><ul><li>Vascular surgeons and interventional cardiologists who use both devices say they would use MiniHawk instead of the SilverHawk in smaller vessel cases . </li></ul></ul><ul><ul><li>Interventional cardiologists and vascular surgeons say they will use MiniHawk instead of the SilverHawk in 11% and 16% respectively, of the total number of peripheral procedures in the lower extremities. </li></ul></ul>
  10. 10. Executive Summary <ul><li>Stent Usage in PAD Treatment </li></ul><ul><ul><li>Vascular surgeons and interventional cardiologists currently use stents for approximately 90% of PAD treatment procedures. Stents are mainly used in the illiac artery and superficial femoral arteries. </li></ul></ul><ul><ul><li>A large majority of interventional cardiologists and vascular surgeons indicate stent effectiveness for treatment of PAD in lower extremities given better efficacy and patency rate of stents. </li></ul></ul><ul><ul><li>About one third of the surveyed physicians anticipate an increase in the usage of stents for PAD treatment over the next year. </li></ul></ul><ul><ul><ul><li>Vascular surgeons also expect a 14% decrease in the use of stents due to SilverHawk usage. </li></ul></ul></ul><ul><li>Awareness of New Technologies </li></ul><ul><ul><li>Neither group of physicians had any awareness of Pathway PV system. </li></ul></ul><ul><ul><li>Among new technologies for PAD treatment, physicians mention cryoplasty and gene therapy most commonly. </li></ul></ul>
  11. 11. Detailed Findings
  12. 12. Section 1: Current Practices
  13. 13. Current Practices On average, interventional cardiologists currently perform about 7 peripheral atherectomy (leg) procedures per month. Q1. In a typical month, how many total interventional procedures do you perform? Q2. What percent of the interventional procedures you perform are for peripheral vascular disease? Q3. What percent of the peripheral interventional procedures you perform are for the lower extremities (legs)? Q4. Of the peripheral procedures you perform in the lower extremities, for what percent do you perform atherectomies? Interventional Procedures/ Month -Interventional Cardiologists- (n=26) 6.9 60% % of Peripheral Interventional Procedures Performed in Lower Extremities that Include Atherectomies 11.6 60% % of Peripheral Interventional Procedures Performed in Lower Extremities 19.3 25% % of Interventional Procedures for Peripheral Vascular Disease Total Interventional Procedures/Month – 77 Total Atherectomies/Month – 6.9 Mean number of procedures performed per month % of Procedures
  14. 14. Current Practices On average, vascular surgeons currently perform about 6 peripheral atherectomy procedures (leg) per month. Q1. In a typical month, how many total interventional procedures do you perform? Q2. What percent of the interventional procedures you perform are for peripheral vascular disease? Q3. What percent of the peripheral interventional procedures you perform are for the lower extremities (legs)? Q4. Of the peripheral procedures you perform in the lower extremities, for what percent do you perform atherectomies? Interventional Procedures/Month -Vascular Surgeons- (n=29) 5.7 21% % of Peripheral Interventional Procedures Performed in Lower Extremities that Include Atherectomies 27.0 71% % of Peripheral Interventional Procedures Performed in Lower Extremities 38.3 71% % of Interventional Procedures for Peripheral Vascular Disease Total Interventional Procedures/Month – 54 Total Atherectomies/Month – 5.7 Mean number of procedures performed per month % of Procedures
  15. 15. Current Practices Vascular surgeons most commonly perform leg atherectomies in the superficial femoral artery. Interventional cardiologists perform these procedures in the illiac artery and common and superficial femoral arteries almost equally. 5. Of the atherectomies you perform in the lower extremities, what percentage are performed in the following arteries? -Interventional Cardiologists- (n=26) -Vascular Surgeons- (n=29) Atherectomy Procedures by Type – Among those who currently perform atherectomies-
  16. 16. Section 2: SilverHawk Usage
  17. 17. SilverHawk Usage Interventional cardiologists and vascular surgeons expect the increase in use of SilverHawk by 3-4 procedures in the next 6 months. 6. Approximately, how many SilverHawk procedures did you perform (per month) six months ago? 7. Approximately, how many SilverHawk procedures will you have performed this month? 8. Approximately, how many SilverHawk procedures do you expect to perform (per month) in six months? SilverHawk Procedures Performed per Month -Among those who currently perform atherectomies-
  18. 18. SilverHawk Usage On average, about 50% of surveyed interventional cardiologists indicate an increase in the use of SilverHawk in the past six months mainly due to ease of use and increased efficacy of the device. 9. How has your usage of SilverHawk changed in the past six months? 10. Please indicate the reason(s) for the change in usage Change in SilverHawk Usage -Interventional Cardiologists- n=26 <ul><li>Increase: </li></ul><ul><li>Ease of use (5) </li></ul><ul><li>Increased efficacy (4) </li></ul><ul><li>More procedures and more combination procedures (3) </li></ul><ul><li>Availability (1) </li></ul><ul><li>Decrease: </li></ul><ul><li>Insufficient data (2) </li></ul>Reasons for Change in Prescribing
  19. 19. SilverHawk Usage More than 50% of surveyed vascular surgeons indicate an increase in the use of SilverHawk in the past six months mainly due to improved results and ease of use of the device. 9. How has your usage of SilverHawk changed in the past six months? 10. Please indicate the reason(s) for the change in usage Change in SilverHawk Usage -Vascular Surgeons- n=29 <ul><li>Increase: </li></ul><ul><li>Improved results (6) </li></ul><ul><li>Increased patient population (2) </li></ul><ul><li>Ease of use (4) </li></ul><ul><li>Availability (3) </li></ul><ul><li>Decrease: </li></ul><ul><li>Poor results (2) </li></ul><ul><li>Poor Availability(3) </li></ul>Reasons for Change in Prescribing
  20. 20. SilverHawk Usage Slightly less than 50 % of interventional cardiologists indicate a possible increase in the use of SilverHawk in the next six months mainly due to increased patient population and ease of use of the device. 11. How do you anticipate your usage of SilverHawk to change in the next six months? 12. Please indicate the reason(s) for the anticipated change in usage. Change in SilverHawk Usage -Interventional Cardiologists- n=26 <ul><li>Increase: </li></ul><ul><li>Improved results (2) </li></ul><ul><li>Increased patient population (5) </li></ul><ul><li>Ease of use (4) </li></ul><ul><li>Availability (1) </li></ul>Reasons for Change in Prescribing
  21. 21. SilverHawk Usage Large majority of vascular surgeons indicate an increase in the use of SilverHawk in the next six months mainly due to increased patient population and improved long-term outcomes of the device. 11. How do you anticipate your usage of SilverHawk to change in the next six months? 12. Please indicate the reason(s) for the anticipated change in usage. Change in SilverHawk Usage -Vascular Surgeons- n=29 <ul><li>Increase: </li></ul><ul><li>Increased patient population (7) </li></ul><ul><li>Improved outcomes (5) </li></ul><ul><li>Ease of use (2) </li></ul><ul><li>Availability (2) </li></ul><ul><li>Increased awareness (2) </li></ul><ul><li>Decrease: </li></ul><ul><li>Poor results (2) </li></ul>Reasons for Change in Prescribing
  22. 22. Number of SilverHawk catheters used per procedure On average, interventional cardiologists and vascular surgeons use 1-2 SilverHawk catheters per procedure. 13. What is the average number of SilverHawk catheters you use per procedure? SilverHawk Usage Mean 1.7 Range (1 – 5) Interventional Cardiologists (n=26) Mean 1.4 Range (1 – 2) Vascular Surgeons (n=29)
  23. 23. SilverHawk Usage Interventional cardiologists currently use Silverhawk for approximately 54% of their peripheral (lower extremity) atherectomy procedures. SilverHawk will be used mainly in the superficial femoral artery and common femoral arteries. 14. What percentage of your peripheral (lower extremity) atherectomies per month is currently performed using SilverHawk? 15. In what arteries do you most commonly utilize SilverHawk? Atherectomies Performed Using SilverHawk -Interventional Cardiologists- (n=26)
  24. 24. SilverHawk Usage Vascular surgeons currently use Silverhawk for approximately 78% of their peripheral (lower extremity) atherectomy procedures. SilverHawk will be used mainly in the superficial femoral and the popliteal arteries. 14. What percentage of your peripheral (lower extremity) atherectomies per month is currently performed using SilverHawk? 15. In what arteries do you most commonly utilize SilverHawk? Atherectomies Performed Using SilverHawk -Vascular Surgeons- (n=29)
  25. 25. SilverHawk Usage Interventional cardiologists have an overall positive impression of SilverHawk, while vascular surgeons have expressed a mixed impression of the device. 16. What is your overall impression of the SilverHawk system? -Interventional Cardiologists- (n=26) Mean Rating: 4.7 -Vascular Surgeons (n=29) Overall Impressions of SilverHawk 1-7 Scale (1-Very negative; 7-Very positive Mean Rating: 5.4
  26. 26. SilverHawk Usage Respondents indicated calcified and occluded vessels as cases that are not effectively treated by SilverHawk. 17. What are the types of lower extremity cases that are not effectively treated with the SilverHawk device? 18. What percentage of the total lower extremity cases fall into these types of cases? Percentage and Types of Cases Not Effectively Treated with SilverHawk -Interventional Cardiologists- -Vascular Surgeons- (n=26) (n=29) <ul><li>Calcified vessels (10) </li></ul><ul><li>Small/hard-to-access vessels (5) </li></ul><ul><li>Total occlusion vessels (1) </li></ul><ul><li>Tibial arteries (1) </li></ul><ul><li>Illiac artery (1) </li></ul>Cases not effectively treated with SilverHawk -Interventional Cardiologists - (n=26 ) 24% Percentage of Total Lower Extremity Cases NOT effectively treated with SilverHawk <ul><li>Calcified vessels (13) </li></ul><ul><li>Long/total occlusion vessels (7) </li></ul><ul><li>Long lesions (5) </li></ul><ul><li>Small/hard to access vessels (2) </li></ul><ul><li>Tibial arteries (1) </li></ul>Cases not effectively treated with SilverHawk -Vascular Surgeons - (n=29) 34% Percentage of Total Lower Extremity Cases NOT effectively treated with SilverHawk
  27. 27. SilverHawk Usage Respondents indicated that SilverHawk could have applications in coronary artery and carotid arteries and it also can be used in stent restinosis cases. 19. In what other areas do you believe the SilverHawk system can be utilized? Other Areas for Utilization of SilverHawk -Interventional Cardiologists- -Vascular Surgeons- (n=26) (n=29) <ul><li>Coronary arteries (4) </li></ul><ul><li>Carotid (3) </li></ul><ul><li>Upper extremity vessels (2) </li></ul><ul><li>Artery occlusion </li></ul><ul><li>Bifurcation lesions (2) </li></ul><ul><li>Smaller vessels (1) </li></ul><ul><li>Below-knee interventions (2) </li></ul><ul><li>Stent restinosis (4) </li></ul><ul><li>Arms (2) </li></ul><ul><li>Illiac (1) </li></ul><ul><li>Large vessels (1) </li></ul><ul><li>Upper extremity vessels </li></ul><ul><li>Long occluded vessels (1) </li></ul><ul><li>Below knee (1) </li></ul><ul><li>In non-diabetic patients </li></ul><ul><li>In older patients </li></ul>
  28. 28. SilverHawk Usage Very few interventional cardiologists were aware of any long-term data related to use of SilverHawk. 20. Are you aware of any long-term data related to use of SilverHawk?. 21. Please list the long-term data related to SilverHawk with which you are familiar Awareness of Long-term Data on SilverHawk -Interventional Cardiologists- (n=26) <ul><li>Specific Long-Term Data Related to SilverHawk (n=3) </li></ul><ul><li>High long-term patency (2) </li></ul><ul><li>Decreased amputation cases (1) </li></ul>
  29. 29. SilverHawk Usage Very few vascular surgeons were aware of any long-term data related to use of SilverHawk. 20. Are you aware of any long-term data related to use of SilverHawk?. 21. Please list the long-term data related to SilverHawk with which you are familiar Awareness of Long-term Data on SilverHawk -Vascular Surgeons- (n=29) <ul><li>Specific Long-Term Data Related to SilverHawk (n=6) </li></ul><ul><li>Average patencies at 2 years of approximately 70% (1) </li></ul><ul><li>Company provided data and presentation at SVS (1) </li></ul><ul><li>Reasonably high recurrence rate (1) </li></ul><ul><li>Approximately 80% primary patency in limited cohort study (1) </li></ul><ul><li>1-yr data showing 80% sfa patency (1) </li></ul><ul><li>60%-70% patency at 6 months (1) </li></ul>
  30. 30. SilverHawk Usage Interventional cardiologists indicate that long-term data has had a very positive impact on their usage of SilverHawk. Vascular surgeons indicate an overall positive impact of long-term data on their usage of the device. -Interventional Cardiologists- (n=3) Mean Impact Rating: 4.7 -Vascular Surgeons (n=6) 1-7 Scale (1- Very negative; 7- Very positive) Mean Impact Rating 6.0 22. What is the impact long-term data related to SilverHawk has had on your usage? Impact of Long-Term Data on SilverHawk Usage
  31. 31. SilverHawk Usage Interventional cardiologists and vascular surgeons indicate that future long-term data is highly important for their usage of SilverHawk. 23. How important is future long-term data related to SilverHawk to your usage? -Interventional Cardiologists- (n=26) Mean Importance Rating: 6.1 -Vascular Surgeons (n=29) 1-7 Scale (1- Not At All Important; 7-Very Important) Mean Importance Rating: 6.2 Importance of Future Long-Term Data on SilverHawk Usage (n=55)
  32. 32. Section 3: MiniHawk Current and Anticipated Perceptions
  33. 33. MiniHawk Anticipated Perceptions 24. Are you familiar with MiniHawk? 25. What is your overall impression of MiniHawk? Interventional cardiologists, while generally unfamiliar with MiniHawk, indicate an overall positive impression with the device. Familiarity and Overall Impression of MiniHawk Interventional Cardiologists (n=26) 5.5 Mean Overall Impression
  34. 34. MiniHawk Anticipated Perceptions 24. Are you familiar with MiniHawk? 25. What is your overall impression of MiniHawk? Vascular surgeons, while generally unfamiliar with MiniHawk, indicate an overall positive impression with the device. Familiarity and Overall Impression of MiniHawk Vascular Surgeons (n=29) 5.2 Mean Overall Impression
  35. 35. MiniHawk Anticipated Perceptions 26. In your opinion, what are the major strengths and weaknesses of MiniHawk? Most commonly, physicians acknowledge better access to smaller vessels as major strengths of the MiniHawk. As major weaknesses, physicians point to MiniHawk’s small size and lack of long-term success. Strengths and Weaknesses of the MiniHawk <ul><li>Low long-term success (3) </li></ul><ul><li>Small capacity for plaque (1) </li></ul><ul><li>Need wire traversal and adequate lumen (1) </li></ul><ul><li>Cost (1) </li></ul><ul><li>Better vessel access (7) </li></ul><ul><li>Small size (5) </li></ul><ul><li>Small size (1) </li></ul><ul><li>Needs multiple passes (1) </li></ul><ul><li>Good for small vessels (4) </li></ul>Weaknesses Weaknesses Strengths -Vascular Surgeons- (n=29) Strengths -Interventional Cardiologists- (n=26)
  36. 36. MiniHawk Anticipated Perceptions 27. In what types of lower extremity cases do you currently use the MiniHawk? Interventional cardiologists and vascular surgeons indicate tibial vessel procedures and below-knee procedures as the most frequent types of lower-extremity cases for which MiniHawk is used. Types of Lower-Extremity Cases for Which MiniHawk Is Used -Interventional Cardiologists- -Vascular Surgeons- (n=4) (n=10) <ul><li>Tibial Vessels (5) </li></ul><ul><li>Diabetic limb salvage (2) </li></ul><ul><li>Pedal arch (1) </li></ul><ul><li>Extra-small vessels (1) </li></ul><ul><li>Distal disease (1) </li></ul><ul><li>Below-knee procedures (3) </li></ul><ul><li>Rare cases of plantar artery disease (1) </li></ul>
  37. 37. MiniHawk Anticipated Perceptions Interventional cardiologists currently use MiniHawk for approximately 15% of their peripheral (lower-extremity) atherectomies. MiniHawk is used mainly in the anterior tibial artery and posterior tibial arteries. 28. In what percentage of your peripheral (lower extremity) atherectomies per month do you currently use the MiniHawk? 29. In what arteries do you most commonly utilize the MiniHawk? Atherectomies Performed Using MiniHawk -Interventional Cardiologists- (n=4)
  38. 38. MiniHawk Anticipated Perceptions Vascular surgeons currently use MiniHawk for approximately 14% of their peripheral (lower- extremity) atherectomies. MiniHawk is used mainly in the peroneal artery and posterior tibial arteries. 28. In what percentage of your peripheral (lower extremity) atherectomies per month do you currently use the MiniHawk? 29. In what arteries do you most commonly utilize the MiniHawk? Atherectomies Performed Using MiniHawk -Vascular Surgeons- (n=12)
  39. 39. MiniHawk Anticipated Perceptions 30. In certain cases, would you use the Minihawk instead of the Silverhawk? 31. In which cases would you use Minihawk instead of Silverhawk? Please explain. Interventional cardiologists who use both devices indicate they would use MiniHawk instead of the SilverHawk in smaller vessel cases. Percentage and Types of Cases in Which MiniHawk May Be Used Instead of SilverHawk -Interventional Cardiologists- (n=4) <ul><li>Smaller vessels (4) </li></ul>Case Types for MiniHawk Use (n=4)
  40. 40. MiniHawk Anticipated Perceptions 30. In certain cases, would you use the Minihawk instead of the Silverhawk? 31. In which cases would you use Minihawk instead of Silverhawk? Please explain. Vascular surgeons who use both devices say they would use MiniHawk instead of the SilverHawk for the most part in smaller vessel cases. Percentage and Types of Cases in Which MiniHawk May Be Used Instead of SilverHawk -Vascular Surgeons- (n=12) <ul><li>Smaller vessels (5) </li></ul><ul><li>Tibial occlusive disease (2) </li></ul><ul><li>Distal disease (1) </li></ul>Case Types for MiniHawk Use (n=8)
  41. 41. MiniHawk Anticipated Perceptions 32. Are there cases in which you would not use Silverhawk, but would consider using Minihawk? 33. Please give the examples of the types of cases in which you would not use SilverHawk, but would consider using MiniHawk? Please explain Interventional cardiologists who use both devices say they would use MiniHawk instead of SilverHawk in smaller vessel cases. Percentage and Types of Cases in Which SilverHawk Would NOT Be Used and MiniHawk Use May Be Considered - Interventional Cardiologists- (n=4) <ul><li>Smaller vessels (3) </li></ul><ul><li>Diffuse disease in vessels less than 2 mm (1) </li></ul>Case Types for MiniHawk Use (n=4)
  42. 42. MiniHawk Anticipated Perceptions 32. Are there cases in which you would not use Silverhawk, but would consider using Minihawk? 33. Please give the examples of the types of cases in which you would not use SilverHawk, but would consider using MiniHawk? Please explain Vascular surgeons who use both devices say they would not use SilverHawk but would consider using MiniHawk for the most part in smaller vessel cases. Percent and types of cases where SilverHawk would NOT be used and MiniHawk Use May Be Considered -Vascular Surgeons- (n=12) <ul><li>Smaller vessels (4) </li></ul><ul><li>Tibial occlusive disease (1) </li></ul><ul><li>Distal disease (1) </li></ul><ul><li>Lesion (1) </li></ul>Case Types for MiniHawk Use (n=7)
  43. 43. MiniHawk Anticipated Perceptions 34. Of the peripheral procedures you perform in the lower extremities, what percent are cases in which you would not use SilverHawk but would use MiniHawk? Interventional cardiologists and vascular surgeons indicate they would not use SlilverHawk but would use MiniHawk in 11% and 16% respectively, of the total number of peripheral procedures in the lower extremities. Share of Anticipated Cases for MiniHawk to be Used Where SilverHawk is not used Interventional Cardiologists n=4 Vascular Surgeons n=8
  44. 44. Section 4: Stent Usage
  45. 45. Stent Usage Interventional cardiologists currently use stents for approximately 90% of PAD treatment procedures. Stents are used mainly in the illiac artery and superficial femoral arteries. 35. Do you currently use stents for PAD in the lower extremities? 36. Where do you most commonly utilize stents in PAD procedures? Atherectomies Performed Using Stents -Interventional Cardiologists- (n=26)
  46. 46. Stent Usage Vascular surgeons currently use stents for approximately 93% of PAD treatment procedures. Stents are used mainly in the illiac artery and superficial femoral arteries. 35. Do you currently use stents for PAD in the lower extremities? 36. Where do you most commonly utilize stents in PAD procedures? Atherectomies Performed Using Stents -Vascular Surgeons- (n=29)
  47. 47. 37. Do you believe stents could be effective for PAD in the lower extremities? 38. Please specify the reasons for your response Stent Usage Stent Effectiveness for PAD Treatment in Lower Extremities Large majority of interventional cardiologists indicate stent effectiveness for treatment of PAD in lower extremities given better efficacy and patency rate of stents. Interventional Cardiologists n=26 <ul><li>Rationale (Pros) </li></ul><ul><li>Better efficacy (7) </li></ul><ul><li>Better patency rate (5) </li></ul><ul><li>Positive data for coronaries (3) </li></ul><ul><li>Restenosis in smaller vessel or large plaque burden (2) </li></ul><ul><li>Better than angioplasty (2) </li></ul><ul><li>Better short-term and angiographic results (2) </li></ul><ul><li>Very effective for large arteries (1) </li></ul><ul><li>Rationale (Cons) </li></ul><ul><li>Limited durability (3) </li></ul><ul><li>Low patency rate (1) </li></ul>
  48. 48. Stent Usage Large majority of vascular surgeons indicate stent effectiveness for treatment of PAD in lower extremities given positive long-term data and stent effectiveness for large arteries. Stent Effectiveness for PAD treatment in Lower Extremities 37. Do you believe stents could be effective for PAD in the lower extremities? 38. Please specify the reasons for your response Vascular Surgeons n=29 <ul><li>Rationale (Pros) </li></ul><ul><li>Short response in patients with high morbidity (1) </li></ul><ul><li>Positive long-term data (5) </li></ul><ul><li>Better than angioplasty (2) </li></ul><ul><li>Better efficacy (2) </li></ul><ul><li>Better short-term and angiographic results (2) </li></ul><ul><li>Better patency rate (3) </li></ul><ul><li>Very effective for large arteries (6) </li></ul><ul><li>Prevent elastic recoil (1) </li></ul><ul><li>Holds open dissections (1) </li></ul><ul><li>Useful in limb salvage (1) </li></ul><ul><li>Rationale (Cons) </li></ul><ul><li>Limited durability (1) </li></ul><ul><li>Large size (1) </li></ul><ul><li>Poor history with restinosis (1) </li></ul>
  49. 49. 39. How do you anticipate your usage of stents for PAD in the lower extremities to change over the next year? 40. Please indicate the reason(s) for the anticipated change in usage. Stent Usage Stent Usage for PAD in Lower Extremities -Interventional Cardiologists- (n=26) One third of interventional cardiologists anticipate increased use of stents for PAD treatment over the next year. <ul><li>Positive outcome data (2) </li></ul><ul><li>Better stents (1) </li></ul><ul><li>Practice increase (3) </li></ul><ul><li>Increased use of Silverhawk (1) </li></ul>
  50. 50. 39. How do you anticipate your usage of stents for PAD in the lower extremities to change over the next year? 40. Please indicate the reason(s) for the anticipated change in usage. Stent Usage Stent Usage for PAD in Lower Extremities -Vascular Surgeons- (n=29) One third of vascular surgeons anticipate increased use of stents for PAD treatment over the next year. Vascular surgeons also expect a 14% decrease in the use of stents due to SilverHawk usage. <ul><li>Improved technology (1) </li></ul><ul><li>Lower-profile devices and long-term follow-up data (1) </li></ul><ul><li>Improved technology (1) </li></ul><ul><li>Wider applications, more experience, and growing clinical practice and reputation (1) </li></ul><ul><li>Minimally invasive; improved patency and success; improved design and manufacturing; patient demand (2) </li></ul><ul><li>Better stents (1) </li></ul><ul><li>Practice increase (1) </li></ul><ul><li>More atherectomies and better balloon technology (1) </li></ul><ul><li>More use of Silverhawk (3) </li></ul>
  51. 51. Section 5: Pathway PV System
  52. 52. 41. Are you aware of Pathway’s investigational device, the Pathway PV System? Pathway PV System Awareness of Pathway PV System Neither group of physicians indicated any awareness of Pathway PV system. Interventional Cardiologists n=26 Vascular Surgeons n=29
  53. 53. 46. Are you aware of any other new devices in development for PAD in the lower extremities? New Technologies <ul><li>Rationale </li></ul><ul><li>Cryoplasty (1) </li></ul><ul><li>Gene therapy (1) </li></ul><ul><li>TURBO-Booster catheter (Spectranetics) (1) </li></ul>Awareness of New Technologies Among new technologies for PAD treatment, physicians most commonly mention cryoplasty and gene therapy. <ul><li>Rationale </li></ul><ul><li>Cryoplasty (2) </li></ul><ul><li>Biodegradable stents (2) </li></ul><ul><li>Gene therapy (1) </li></ul><ul><li>Laser (2) </li></ul><ul><li>Catheters for complete occlusions (1) </li></ul>Interventional Cardiologists n=26 Vascular Surgeons n=29

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