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Qualitative Research

Quantitative Research

Profiles

MedPanel, Inc. 44 Brattle St., Cambridge, MA 02138 617-661-8080 www.medpanel.com

KNOWLEDGE CAPTURED. INTELLIGENCE DELIVERED.

Usage of SilverHawk and MiniHawk Catheters for Peripheral Atherectomies

Intelligence Report

By MedPanel, Inc.

September 2006

2

Contents Study Objectives 2 Methodology & Sample 3 Respondent Background Information 4 Executive Summary 5 - 9 Detailed Findings 10 -

52

3

Study Objectives

Primary Objective:

Specific Objectives:

Understand the current landscape of the peripheral atherectomy market

Assess current usage and perceptions of the SilverHawk catheters

Determine expected future use and trends for SilverHawk catheters

Gauge current usage and perceptions of the MiniHawk catheters

Determine expected future use and trends for MiniHawk catheters

Determine expected future use and trends for stent in PAD procedures

Measure physician awareness of the new technologies in PAD treatment

Understand current usage and expected trends in usage of SilverHawk and MiniHawk catheters for peripheral atherectomies

4

Methodology and Sample

Survey Specifics:

A 20-minute self-administered survey was fielded online via MedPanel’s Web site from September 5 - September 13, 2006.

Sample:

The sample comprised 26 interventional cardiologists and 29 vascular surgeons

Physicians were selected from across the U.S.

To qualify, respondents were required to meet the following criteria:

Primary specialty in interventional cardiology or vascular surgery

In practice between 2 and 30 years

Spend greater than 70% of their time in clinical practice

Currently see at least 50 patients/year with peripheral vascular disease

Perform interventional procedures in peripheral arteries

Currently perform or plan to perform peripheral atherectomies this year

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)

46%54%

Academic/Teaching HospitalCommunity Hospital

34%

66%

Academic/Teaching Hospital

Community Hospital

Primary Practice Setting- Vascular Surgeons-

(n=29)

Years in practice 9.6 (2 – 20) 12.5 (5 – 25)

Percentage of time in clinical practice 95 (80 – 100) 97 (80 – 100)

Number of patients with peripheral vascular disease 447 (50 – 1,000) 969 (100 – 3,000)

Vascular Surgeons

Mean RangeInterventional Cardiologists

Mean Range

6

Executive Summary

7

Executive Summary

Current Practices for PAD Treatment – Leg Atherectomies Interventional cardiologists currently perform about 7 peripheral atherectomy procedures per month.

Vascular surgeons currently perform about 6 peripheral atherectomy procedures per month.

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.

8

Executive Summary

SilverHawk Usage and Perceptions Interventional cardiologists and vascular surgeons expect the increase in use of SilverHawk by 3-4 procedures in the next 6 months.

On average about 50% of interventional cardiologists and vascular surgeons indicate an increase in the use of SilverHawk in the past six months.

On average 50 % of interventional cardiologists and vascular surgeons indicate an increase in the use of SilverHawk in the next six months.

Interventional Cardiologists have a very positive impression of SilverHawk catheters.

Interventional cardiologists primarily use SilverHawk in the superficial femoral, common femoral, and illiac arteries.

Vascular surgeons have a more mixed impression of SilverHawk catheters.

Vascular surgeons primarily use SilverHawk in the superficial femoral and popliteal arteries.

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.

9

Executive Summary

MiniHawk Usage and Perceptions Physicians generally were not familiar with MiniHawk but indicate an overall positive impression with the device.

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.

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.

Vascular surgeons and interventional cardiologists currently use MiniHawk for approximately 14% of their peripheral (lower extremity) atherectomies.

Vascular surgeons and interventional cardiologists who use both devices say they would use MiniHawk instead of the SilverHawk in smaller vessel cases.

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.

10

Executive Summary

Stent Usage in PAD Treatment 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.

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.

About one third of the surveyed physicians anticipate an increase in the usage 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.

Awareness of New Technologies Neither group of physicians had any awareness of Pathway PV system.

Among new technologies for PAD treatment, physicians mention cryoplasty and gene therapy most commonly.

11

Detailed Findings

12

Section 1:Current Practices

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)

Total Interventional Procedures/Month – 77Total Atherectomies/Month – 6.9

% of Procedures

Mean number of procedures performed

per month

% of Interventional Procedures for Peripheral Vascular Disease 25% 19.3

% of Peripheral Interventional Procedures Performed in Lower Extremities

60% 11.6

% of Peripheral Interventional Procedures Performed in Lower Extremities that Include Atherectomies

60% 6.9

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)

Total Interventional Procedures/Month – 54Total Atherectomies/Month – 5.7

% of Procedures

Mean number of procedures performed

per month

% of Interventional Procedures for Peripheral Vascular Disease 71% 38.3

% of Peripheral Interventional Procedures Performed in Lower Extremities

71% 27.0

% of Peripheral Interventional Procedures Performed in Lower Extremities that Include Atherectomies

21% 5.7

15

2%

2%

4%

9%

40%

8%

15%

20%

Peroneal artery

Posterior tibial artery

Anterior tibial artery

Popliteal artery

Superficial femoral artery

Profundis femoris

Common femoral artery

Illiac Artery

7%

7%

8%

18%

41%

3%

9%

7%

Peroneal artery



Popliteal artery


Profundis femoris


Illiac Artery

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

Section 2:SilverHawk Usage

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?

7.0

4.0

3.0

9.3

5.4

4.8

In 6 Months

This Month

6 Months Ago

Vascular Surgeons (n=29) Interventional Cardiologists (n=26)

SilverHawk Procedures Performed per Month-Among those who currently perform atherectomies-

18

SilverHawk Usage

50%

42%

8%

0%

25%

50%

75%

100%

Increase No Change Decrease

Per

cen

tag

e o

f P

hys

icia

ns

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

Reasons for Change in Prescribing

Increase: Ease of use (5) Increased efficacy (4) More procedures and more combination procedures (3) Availability (1)

Decrease: Insufficient data (2)

19

SilverHawk Usage

52%

31%

17%

0%

25%

50%

75%

100%

Increase No Change Decrease

Per

cen

tag

e o

f P

hys

icia

ns

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


Increase: Improved results (6) Increased patient population (2) Ease of use (4) Availability (3)

Decrease: Poor results (2) Poor Availability(3)

20

SilverHawk Usage

46%

54%

0%0%

25%

50%

75%

100%

Increase Remain the same Decrease

Per

cen

tag

e o

f P

hys

icia

ns

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


Increase: Improved results (2) Increased patient population (5) Ease of use (4) Availability (1)

21

SilverHawk Usage

66%

28%

7%

0%

25%

50%

75%

100%


Per

cen

tag

e o

f P

hys

icia

ns

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


Increase: Increased patient population (7) Improved outcomes (5) Ease of use (2) Availability (2) Increased awareness (2)

Decrease: Poor results (2)

22

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?

Number of SilverHawk catheters used per procedure

Interventional Cardiologists (n=26) Mean 1.7 Range (1 – 5)

SilverHawk Usage

Vascular Surgeons (n=29) Mean 1.4 Range (1 – 2)

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)

1%

3%

4%

9%

44%

5%

19%

15%

Peroneal artery



Popliteal artery


Profundis femoris


Illiac Artery

46%

54%

0%

20%

40%

60%

80%

100%

Non-Silver Hawk SilverHawk

24

SilverHawk Usage

22%

78%

0%

20%

40%

60%

80%

100%

Non-Silver Hawk SilverHawk

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)

10%

11%

11%

21%

41%

1%

3%

2%

Peroneal artery



Popliteal artery


Profundis femoris


Illiac Artery

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?


0%

0%

4%

4%

54%

27%

12%

Very Negative

Neutral

Very Positive

Mean Rating: 4.7

0%

10%

7%

14%

38%

28%

3%

Very Negative

Neutral

Very Positive

-Vascular Surgeons(n=29)

Overall Impressions of SilverHawk

1-7 Scale (1-Very negative; 7-Very positiveMean Rating: 5.4

26

SilverHawk Usage

Respondents indicated calcified and occluded vessels as cases that are not effectively treated by SilverHawk.

Cases not effectively treated with SilverHawk

-Interventional Cardiologists -(n=26)

Calcified vessels (10) Small/hard-to-access vessels (5) Total occlusion vessels (1) Tibial arteries (1) Illiac artery (1)

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 of Total Lower Extremity Cases NOT effectively treated with SilverHawk

24%

Cases not effectively treated with SilverHawk

-Vascular Surgeons -(n=29)

Calcified vessels (13) Long/total occlusion vessels (7) Long lesions (5) Small/hard to access vessels (2) Tibial arteries (1)

Percentage of Total Lower Extremity Cases NOT effectively treated with SilverHawk

34%

Percentage and Types of Cases Not Effectively Treated with SilverHawk

-Interventional Cardiologists- -Vascular Surgeons-

(n=26) (n=29)

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?

Coronary arteries (4) Carotid (3) Upper extremity vessels (2) Artery occlusion Bifurcation lesions (2) Smaller vessels (1) Below-knee interventions (2)

Stent restinosis (4) Arms (2) Illiac (1) Large vessels (1) Upper extremity vessels Long occluded vessels (1) Below knee (1) In non-diabetic patients In older patients

Other Areas for Utilization of SilverHawk


(n=26) (n=29)

28

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

88%

12%

0%

20%

40%

60%

80%

100%

No Yes

Awareness of Long-term Data on SilverHawk


SilverHawk Usage

Specific Long-Term Data Related to SilverHawk

(n=3)

High long-term patency (2) Decreased amputation cases (1)

29

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

79%

21%

0%

20%

40%

60%

80%

100%

No Yes

Awareness of Long-term Data on SilverHawk

-Vascular Surgeons-(n=29)

SilverHawk Usage

Specific Long-Term Data Related to SilverHawk (n=6)

Average patencies at 2 years of approximately 70% (1) Company provided data and presentation at SVS (1) Reasonably high recurrence rate (1) Approximately 80% primary patency in limited cohort study (1) 1-yr data showing 80% sfa patency (1) 60%-70% patency at 6 months (1)

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.


0%

0%

0%

33%

0%

0%

67%

Negative

No Impact

Positive

Mean Impact Rating: 4.7

0%

0%

17%

17%

50%

17%

0%

Negative

No Impact

Positive


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

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?


0%

0%

0%

11%

12%

27%

50%

Not At All Important

Very Important

Mean Importance Rating: 6.1

0%

0%

3%

7%

10%

35%

45%

Not At All Important

Very Important


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

Section 3:MiniHawk Current and Anticipated Perceptions

33

MiniHawk Anticipated Perceptions

15%

85%

0%

20%

40%

60%

80%

100%

Yes No0%

0%

0%

25%

25%

25%

25%

Very Negative

Neutral

Very Positive

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)

Mean Overall Impression

5.5

34


41%

59%

0%

20%

40%

60%

80%

100%

Yes No

0%

0%

0%

33%

33%

17%

17%

Very Negative

Neutral

Very Positive

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)

Mean Overall Impression

5.2

35


26. In your opinion, what are the major strengths and weaknesses of MiniHawk?

-Interventional Cardiologists- (n=26)

-Vascular Surgeons- (n=29)

Strengths Weaknesses Strengths Weaknesses

Good for small vessels (4) Small size (1) Needs multiple passes (1)

Better vessel access (7) Small size (5)

Low long-term success (3) Small capacity for plaque (1) Need wire traversal and adequate lumen (1) Cost (1)

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

36


27. In what types of lower extremity cases do you currently use the MiniHawk?

Below-knee procedures (3) Rare cases of plantar artery disease (1)

Tibial Vessels (5) Diabetic limb salvage (2) Pedal arch (1) Extra-small vessels (1) Distal disease (1)

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


(n=4) (n=10)

37


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)

25%

16%

23%

23%

6%

5%

1%

0%

0%

Other

Peroneal artery



Popliteal artery


Profunda femoris


Illiac Artery

15%

85%

0%

20%

40%

60%

80%

100%

MiniHawk Non-MiniHawk

38


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)

28%

27%

23%

22%

0%

0%

0%

0%

0%

Other

Peroneal artery



Popliteal artery


Profunda femoris


Illiac Artery

14%

86%

0%

20%

40%

60%

80%

100%

MiniHawk Non-MiniHawk

39


100%

0%

20%

40%

60%

80%

100%

No Yes

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.

Case Types for MiniHawk Use (n=4)

Smaller vessels (4)

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)

40


33%

67%

0%

20%

40%

60%

80%

100%

No Yes

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.

Case Types for MiniHawk Use(n=8)

Smaller vessels (5) Tibial occlusive disease (2) Distal disease (1)

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)

41


100%

0%

20%

40%

60%

80%

100%

No Yes

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

Case Types for MiniHawk Use(n=4)

Smaller vessels (3) Diffuse disease in vessels less than 2 mm (1)

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 Usedand MiniHawk Use May Be Considered

-Interventional Cardiologists- (n=4)

42


33%

67%

0%

20%

40%

60%

80%

100%

No Yes

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

Case Types for MiniHawk Use (n=7)

Smaller vessels (4) Tibial occlusive disease (1) Distal disease (1) Lesion (1)

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)

43


89%

11%

0%

20%

40%

60%

80%

100%

Non-MiniHawk Cases MiniHawk Cases

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

84%

16%

0%

20%

40%

60%

80%

100%

Non-MiniHawk Cases MiniHawk Cases

Interventional Cardiologists

n=4

Vascular Surgeonsn=8

44

Section 4:Stent Usage

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)

1%

1%

2%

6%

26%

6%

11%

48%

Peroneal artery



Popliteal artery


Profunda femoris


Illiac Artery

8%

92%

0%

20%

40%

60%

80%

100%

Do not use Use

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)

0%

1%

1%

3%

27%

0%

1%

66%

Peroneal artery



Popliteal artery


Profunda femoris


Illiac Artery

7%

93%

0%

20%

40%

60%

80%

100%

Do not use Use

4737. Do you believe stents could be effective for PAD in the lower extremities? 38. Please specify the reasons for your response

Stent Usage

15%

85%

0%

20%

40%

60%

80%

100%

No Yes

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 Cardiologistsn=26

Rationale (Pros) Better efficacy (7) Better patency rate (5) Positive data for coronaries (3) Restenosis in smaller vessel or large plaque burden (2) Better than angioplasty (2) Better short-term and angiographic results (2) Very effective for large arteries (1)

Rationale (Cons) Limited durability (3) Low patency rate (1)

48

10%

90%

0%

20%

40%

60%

80%

100%

No Yes


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

Rationale (Pros) Short response in patients with high morbidity (1) Positive long-term data (5) Better than angioplasty (2) Better efficacy (2) Better short-term and angiographic results (2) Better patency rate (3) Very effective for large arteries (6) Prevent elastic recoil (1) Holds open dissections (1) Useful in limb salvage (1)

Rationale (Cons) Limited durability (1) Large size (1) Poor history with restinosis (1)

49

61%

4%

33%

0%

20%

40%

60%

80%

100%


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.

Positive outcome data (2) Better stents (1) Practice increase (3)

Increased use of Silverhawk (1)

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.

50

52%

14%

34%

0%

20%

40%

60%

80%

100%


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.

Improved technology (1) Lower-profile devices and long-term follow-up data (1) Improved technology (1) Wider applications, more experience, and growing clinical practice and reputation (1) Minimally invasive; improved patency and success; improved design and manufacturing; patient demand (2) Better stents (1) Practice increase (1)

More atherectomies and better balloon technology (1) More use of Silverhawk (3)

51

Section 5:Pathway PV System

5241. 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.

100%

0%

20%

40%

60%

80%

100%

Not aware Aware

100%

0%

20%

40%

60%

80%

100%

Not aware Aware



5346. Are you aware of any other new devices in development for PAD in the lower extremities?

New Technologies

91%

9%

0%

20%

40%

60%

80%

100%

No Yes

Rationale• Cryoplasty (1)• Gene therapy (1)• TURBO-Booster catheter (Spectranetics) (1)

Awareness of New Technologies

Among new technologies for PAD treatment, physicians most commonly mention cryoplasty and gene therapy.

75%

25%

0%

20%

40%

60%

80%

100%

No Yes

Rationale• Cryoplasty (2) • Biodegradable stents (2) • Gene therapy (1)• Laser (2) • Catheters for complete occlusions (1)



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