ACUTE LIMB ISCHEMIA Table of Contents

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ACUTE LIMB ISCHEMIA Table of Contents PERIPHERAL ARTERIAL DISEASE (PAD)... 1 INTERMITTENT CLAUDICATION (IC)... 1 CRITICAL LIMB ISCHEMIA (CLI)... 1 ACUTE LIMB ISCHEMIA (ALI)... 2 Risk Factors...2 Associated With Femoropopliteal and Type III Disease... 3 The Most Severe Form of Peripheral Disease... 3 PRIMARY CAUSES THROMBOSIS OR EMBOLISM... 3 THROMBOSIS... 4 Most Common Sites of Thrombosis... 4 Risk Factors for Thrombosis and Embolism... 4 EMBOLISM... 5 Most Common Sites of Embolism... 5 Causes... 5 BYPASS GRAFT OCCLUSIONS... 5 POPLITEAL OR FEMORAL ARTERY ANEURYSM... 5 CLINICAL CLASSIFICATIONS OF ACUTE LIMB ISCHEMIA... 6 ISCHEMIC INJURY... 7 CONSEQUENCES MORTALITY AND LIMB LOSS... 7 Mortality Cause of Death... 8 Amputation... 8 Primary Amputation... 8 Risk of Limb Loss Increases With Duration of Ischemia... 8 SURVIVORS EXPERIENCE RAPID DETERIORATION... 9 Two-Year Outcome... 9 Exceptionally High Five-Year Mortality... 10 SURVIVORS OF ALI, AMI AND STROKE COMPARED... 10 30-Day Mortality Higher Than MI or Stroke... 10 Morbidity and Mortality ALI, AMI and Stroke... 11 TREATMENT... 12 Initial Therapy Anticoagulation... 12 Frail Elderly Patients with Serious Co-Morbidities... 13 Amputation or Revascularization... 13 Multiple Therapies Are The Norm... 14 SURGERY... 14 Thromboembolectomy... 15 Bypass Grafts... 15 Replacement Bypass Surgery... 15 Thrombolysis... 16 Outcome... 16 Limb Salvage and Mortality... 16

Complications... 16 Reperfusion Injury... 17 Compartment Syndrome... 18 THROMBOLYSIS... 18 Regional Lysis... 18 Advantages... 19 Disadvantages... 19 Clinical Outcomes... 20 Factors That Influence Amputation-Free Survival... 20 Factors Associated With Higher Mortality... 21 Complications... 21 Contraindications... 22 PLASMINOGEN ACTIVATORS... 22 Streptokinase... 22 Urokinase... 23 Prourokinase... 23 ThromboClear... 23 Tissue Plasminogen Activators (t-pa)... 24 Activase... 24 TNKase... 24 Retavase... 24 Fibrin Specificity... 24 Limitations of Plasminogen Activators... 25 Mechanism of Activity... 25 Strategies to Overcome Limitations... 26 PLASMINOGEN ACTIVATORS COMPARED... 26 Difficult to Conclude That One Agent is Superior... 26 Research is Sparse and Often Flawed... 27 Similar Range of Bleeding Complications... 27 Efficacy and Safety... 27 Retavase RELAX Trial... 28 TNKase... 29 THROMBOLYSIS AND SURGERY COMPARED... 30 Three Prospective Randomized Trials... 30 Meta-Analyses... 31 THE ROLE OF GPIIb/IIIa INHIBITORS... 32 Rationale for the Addition of Antiplatelet Agents... 32 Benefit in the Coronary Setting... 32 Potential Advantages in Acute Limb Ischemia... 33 FDA-Approved GP IIb/IIIa Inhibitors... 33 ReoPro... 34 Peripheral Experience... 34 Aggrastat... 36 Peripheral Experience... 36 Integrilin... 37 Peripheral Experience... 37

Comparison of GP IIb/IIIa Inhibitors... 38 PLASMINOGEN ACTIVATORS IN RESEARCH... 39 Staphylokinase... 40 Desmoteplase... 41 DIRECT FIBRINOLYTIC DRUGS... 41 Plasmin... 41 Microplasmin... 42 Fibrolase... 42 Alfimeprase... 42 Clinical Trial Results in Acute Limb Ischemia... 43 Phase III Trials in ALI... 44 NEW PHARMACEUTICAL APPROACHES UNDER INVESTIGATION... 44 TAFIa Inhibitors... 45 Dual Activity Agents... 45 Combined Antiplatelet and Anticoagulant Activity... 45 Combined Fibrinolytic and Anticoagulant Activity... 45 Proteomics... 45 THROMBOLYTIC INFUSION CATHETERS... 45 PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT)... 46 FDA-Approved Devices... 46 Limitations... 48 Complications... 48 THROMBUS DISRUPTION DEVICES... 49 Helix... 49 THROMBUS ASPIRATION DEVICES... 49 Pronto... 50 Export Catheter... 50 THROMBUS DISRUPTION AND ASPIRATION DEVICES... 50 Maceration and Aspiration... 50 X-Sizer Catheter System... 50 Thrombex PMT System... 50 Endovac... 51 Rheolytic Thrombectomy... 51 AngioJet System... 51 Advantages... 52 Efficacy... 52 Adjunctive Procedures... 53 Mortality and Amputation... 53 Complications... 54 Hydrolyser... 54 Efficacy... 54 Adjunctive Procedures... 55 Mortality and Amputation... 55 Complications... 55 Oasis... 55 Efficacy and Complications... 55

ISOLATED THROMBOLYSIS... 55 Bacchus Trellis... 55 Efficacy... 56 Adjunctive Procedures... 56 Complications... 57 ULTRASONIC THROMBECTOMY... 57 Mechanism of Operation... 57 Safety... 58 Optimal Parameters... 58 Frequency and Power... 58 ENDOVASCULAR ULTRASOUND SYSTEMS... 59 Resolution 360 System... 59 Lysus Infusion System... 60 Acolysis System... 61 ULTRASOUND-MEDIATED MICROBUBBLE DESTRUCTION... 61 Microbubbles For Thrombus... 61 Targeted Drug and Gene Delivery... 62 SonoLysis... 62 In Acute Ischemic Stroke... 63 Thrombosed Dialysis Grafts... 64 Deep Vein Thrombosis... 64 Acute Limb Ischemia... 64 Other Commercial Microbubbles... 64 Optison... 64 Imagent/Imavist... 65 Levovist... 65 SonoVue... 65 Albunex... 66 Microbubbles in Late Clinical Trials for Myocardial Perfusion Assessment... 66 OTHER NEW PERCUTANEOUS APPROACHES... 66 CliRpath Excimer Laser... 66 COMBINATION THERAPY... 67 Debulking... 67 Power Pulse Spray (PPS)... 67 Technique Description... 67 Safety and Efficacy of Power Pulse Spray... 68 SURGERY, THROMBOLYSIS, ANGIOJET AND PPS COMPARED... 69 Outcomes... 69 Cost... 70 Thrombolysis... 71 Surgery... 72 Amputation... 72 AngioJet... 73 Power Pulse Spray (PPS)... 73 NUMBER OF PATIENTS PRESENTING WITH ALI... 74 Incidence of Acute Limb Ischemia... 74

Estimates Based on PAD Interventional Procedures... 74 Estimates Based on Critical Limb Ischemia... 75 National Hospital Discharge Survey Data... 76 Estimated Number of ALI Procedures... 76 Percentage of Bypass Operations Due to ALI... 76 Percentage of Amputations Due to ALI... 77 Percentage of ALI-Related Thrombolytic, Heparin and GP IIb/IIIa Infusions... 77 Conclusions Regarding Number of ALI Patients... 77 ESTIMATED NUMBER OF ACUTE LIMB ISCHEMIA PATIENTS... 77 Based on Number of PAD Patients 2000 to 2020... 77 Assumptions and Methods... 78 Estimated Number of CLI and ALI Patients 2000-2020... 78 ALI Patients Expected to Decline as a Percentage of CLI Patients... 79 Factors That Could Mitigate The Decline... 80 ALI MARKET ANALYSIS METHODOLOGY... 81 ALI MARKET ESTIMATES IN NUMBER OF PROCEDURES 2000-2020... 81 Number of Primary Procedures per Patient... 81 Number of Patients Needing Revision Therapy... 82 Data on ALI Recurrence... 82 MARKET VALUE 2000-2020... 83 CONTRALATERAL ACUTE LIMB ISCHEMIA... 84 Occurrence of Contralateral PAD... 84 Data on Contralateral ALI... 85 NUMBER OF ALI CASES BY PRIMARY CAUSE THROMBOSIS AND EMBOLISM... 85 ALI Caused by Thrombosis 2000-2020... 86 ALI Caused by Embolism 2000-2020... 86 ALI PATIENTS IN EACH CLINICAL CLASSIFICATION... 87 Percentage of Patients in Each SVS-ISCVS Classification... 87 Number in Each SVS-ISCVS Classification 2004... 88 Number of ALI Patients in Each Clinical Classification 2000-2020... 88 RECOMMENDED INITIAL THERAPY BY CLINICAL CLASSIFICATION... 89 PRIMARY MARKET POTENTIAL BY CLINICAL CLASSIFICATION... 90 Definitions... 90 Primary Market Potential Based on Current Recommended Initial Therapy 2005... 91 CLINICAL CATEGORY III... 92 Percentage of Early and Late Presentation Forecast to Change... 92 THROMBOLYTIC THERAPY... 93 Primary Market Potential for Currently Approved Thrombolytics... 93 Primary Market for Isolated Thrombolysis Devices... 94 Primary Market for Devices to Speed Clot Dissolution... 94 Primary Market for New Safer Thrombolytics... 94 Primary Market for Microbubbles... 95 PMT THERAPY... 95 Primary Market Potential for Percutaneous Mechanical Thrombectomy... 95 Primary Market for New Endovascular Devices... 96

GP IIb/IIIa INHIBITORS... 98 Primary Market Potential for GP IIb/IIIa Therapy... 98 THROMBOEMBOLECTOMY... 99 Primary Market Potential for Surgical Thromboembolectomy... 99 REFERENCES... 100 INDEX OF TABLES AND FIGURES... 120 LIST OF COMPANIES... 122 DISCLOSURE STATEMENT... 124 CONTACT INFORMATION... 125

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