Understanding the Peripheral Vascular Toolkit: An Analysis of Trends, Strategies and Opportunities in the U.S. Peripheral Intervention Market

Understanding the Peripheral Vascular Toolkit:

An Analysis of Trends, Strategies and

Opportunities in the U.S. Peripheral Intervention Market

Teri MinorSenior Industry Analyst, Medical Devices

HealthcareFrost & Sullivan

September 29, 2009

2

� Peripheral Vascular Disease overview

� Types of treatments for Peripheral Vascular Disease

� Shifts in types of procedures and physician specialties

� Future technologies and products

Focus Points

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3

Peripheral Vascular Disease Still Growing in the U.S.

•In 2008 the Peripheral Vascular Disease Market was growing from 5% to 10% from historical growth rates of 15%.

•Patients are delaying visits for screening, causing a delay in diagnosis.

•In 2008 there were approximately 3.6 million interventional procedures for the diagnosis and treatment of Peripheral Vascular Disease.

•The American Hospital Association states that Peripheral Vascular disease significantly increases the risk of stroke or heart attack.

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Growing Rate of Peripheral Vascular Disease in the U.S.

Comorbidity for

Peripheral Vascular

Disease is high with

lower survival rates

than some forms of

cancer

Peripheral Vascular

Disease

significantly under-

diagnosed; less

than 1 in 3 patients

An estimated 30% of

individuals in the U.S.

afflicted with

Peripheral Vascular

Disease die within 5

years.

10 million people in U.S.

with Peripheral Vascular

Disease growing 5% - 10%

Peripheral Vascular Disease

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Treating Peripheral Vascular Disease

Disease Treatment

• Surgical procedures Saphenous Vein or ePTFE Grafts

• Drug Therapy Advancements in treatment of obesity, diabetes, and vascular

disease

• Interventional Treatments

• Stents

• Atherectomy Devices

• PTA Balloon Catheters

• Stent Grafts

• Thrombectomy

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Growth and Strategy – Peripheral Vascular Key Segments

Changing Market Landscape:

•Over 100,000 lower limb amputations

• In 2008 stents represented 41% of treatment

•On-going active efforts to improve screening and awareness

•Endovascular interventions increased more than threefold while bypass decreased -4%

•Wide range of treatment options available: balloon angioplasty; atherectomy; thrombectomy; stenting; vascular compression;

venous ablation

Peripheral Vascular Key Segments

Peripheral

Stents

41%

Atherectomy

13%Thrombectomy

10%

Stent-Graft SFA

12%

PTA Balloon

Catheters

15%

Surgical Grafts

9%

Peripheral Stents

Atherectomy

Thrombectomy

Stent-Graft SFA

PTA Balloon Catheters

Surgical Grafts

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Key Interventional Treatment Segments

Company Stenting Angioplasty

Advanced

Baloon Thrombectomy Atherectomy

Carotid

Stent

Embolic

Protection

Abbott Laboratories X X X X

Angioscore X

Boston Scientific X X X X X X

Cardiovascular Systems X

Cordis- J&J X X X X

CR Bard X X

Edwards Lifesciences X X

ev3 X X X X X X

Idev X

Medtronic X X X X

Pathway medical

Possis X

Spectranetics X

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2008 Peripheral Stent Market Key Indications

•The Market for peripheral vascular stents has not yet become standardized or saturated

•Stent placements account for over 35% of all peripheral vascular interventions in 2008

•High Fracture Rates and CMS reimbursement has limited growth

Peripheral Stent Market Overview

2008 PERIPHERAL STENTS BY INDICATION

Illiac

37%

Femoral-

Popliteal

27%

Renal

23%

Carotid

13%Illiac

Femoral-Popliteal

Renal

Carotid

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Open Surgical Procedures Marketing Losing to MIT

As with other sectors, open surgical procedures for peripheral vascular

disease treatment is being replaced by interventional treatments.

• Open surgical options include ePTFE vascular grafts and saphenous

vein bypass.

• Peripheral Interventions have quicker recovery and are less invasive.

• Patient awareness increases as more physicians adopt minimally

invasive technologies.

• FDA approval of SFA treatment will shift the market.

• Better technologies in stents, and athrectomy devices increase

adoption.

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Shift in Treatment Segments for Peripheral Vascular

•There has been a tremendous shift over the past 5 years in treatment

of peripheral vascular disease, from surgical to interventional

procedures.

•Due to the associated risks open surgical treatment is considered a

last resort, and the market is looking for safer alternatives.

•Open surgical device sales of ePTFE grafts declining rapidly.

•High restenosis rates often perceived as justifiable compared to

surgery.

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Device and Treatment Shifts Drive Shifts in Surgeon Specialty

• The success of interventional treatment for peripheral vascular disease has driven a shift in physician specialty performing procedures.

• Vascular surgeons who traditionally treated Peripheral Vascular Disease, were slow to adopt losing cases to cardiologists, interventional radiologists, radiologists, and interventional cardiologists.

• As the market for coronary interventions matures, cardiologists will be looking for work in the peripheral field. This trend is already occurring in the U.S. and expected to accelerate.

Key Users2005 2008

Interventional Cardiologists 35% 50%

Vascular Surgeons 25% 35%

Interventional Radiologists 40% 15%

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Physician Specialties Performing Peripheral Interventions

Vascular

SurgeonsVascular

Surgeons

CardiologistsCardiologists

RadiologistsRadiologists

Interventional

CardiologistsInterventional

Cardiologists

Peripheral Vascular

Interventions

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Trends for the Future

-Market Trends

• High growth areas are Carotid stents, Lower Limb, and Atherectomy.

• The stent market is poised to take off; however, there continue to be

regulatory issues and confidence from providers which hold the market from

reaching the full potential.

• Interventional procedures continue to take away from surgical procedures

-New Devices – Increase Usage – Improve Outcomes

• Cook Medical clinical trial of Zilver PTX-Blockages in Femoropopliteal Artery

paclitaxel-coated stent use for outside the heart

• Ev3 enrolling trail for SFA indication for its EverFlex stent

• New Atherectomy devices hitting the market

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Conclusion

FDA approval for peripheral stents could increase usage by 50%

Peripheral Vascular is a hot opportunity

Research of new technologies such as drug-eluting stents are still to be played out

Alternative treatments such as atherectomy will drive revenues

Peripheral Vascular Outlook

There has still been no “gold standard” to emerge

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Voice of the Clinician: Understanding the PV Intervention Toolkit End User Analysis

Frost & Sullivan is currently conducting a project seeking to trend the current and near term market for

peripheral intervention products – based on data from ~150 clinical specialists, including vascular

surgeons, interventional cardiologists, and interventional radiologists:

Objectives:

• Evaluate behavior analytics and probe for unmet needs of interventionalists and vascular surgeons

pertaining to their practice

• Uncover adoption trends, treatment selection criteria and prevalence of off-label usage of stents,

• Assess levels of patient awareness, and trends related to screening and diagnosis.

• Understand purchasing structure and other institutional factors impacting utilization

• This study would also probe patient pathways, awareness/access to newer technologies, current and

expected patient demographics, product preferences, access to care, and other dynamics that can shape

overall market projections.

28%

26%

15%

18%

23%

15%

28%

26%

15%

18%

23%

33%

10%

21%

21%

15%

21%

33%

10%

21%

21%

15%

10%

18%

31%

26%

15%

10%

36%

3%

3%

8%

15%

18%

3%

3%

3%

8%

15%

18%

18%

31%

26%

15%

26%

36%

31%

36%

38%

36%

21%

36%

38%

31%

21%Cordis J&J

Medtronic

Boston Scientific

Abbott Vascular

ev3

Cook Medical

Foxhollow (ev3)

Pathway Medical

Cardiovascular Systems

Spectranetics

Boston Scientific

Currently using Have used in the past Have seen demo or tested Have heard of Was not aware of

SAM

PLE

Early Adopters

Most receptive to new

technologies and forms of treatments.

Risk Averse

Certain clinicians who are well set in their practice, are sometimes more resistant to change. They require higher levels of scrutiny and evaluation of new technologies before they are

willing to adopt or consider incorporating those treatments into their practice.

Evidence-BasedThe result of clinical tests and the experience of peers is this segment’s top concern.

22%

32%

46%

Early Adopters

Most receptive to new

technologies and forms of treatments.

Risk Averse

Certain clinicians who are well set in their practice, are sometimes more resistant to change. They require higher levels of scrutiny and evaluation of new technologies before they are

willing to adopt or consider incorporating those treatments into their practice.

Evidence-BasedThe result of clinical tests and the experience of peers is this segment’s top concern.

22%

32%

46%

SAMPLE

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Next Steps

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179/29/2009

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189/29/2009

For Additional Information

For Additional Information

Teri Minor

Industry Analyst, Medical Devices

Healthcare & Life Sciences Research

901-270-0399

[email protected]

Carol Skloss

Director of Sales

Healthcare & Life Sciences

210-247-3810

[email protected]

Venkat Rajan

Industry Manager, Medical Devices

Healthcare & Life Sciences Research

210-247-2427

[email protected]