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Cardiac Assist Devices (CAD)

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1 EXECUTIVE SUMMARY 25

    2 INTRODUCTION 30

    • 2.1 KEY TAKEAWAYS 30
    • 2.2 REPORT DESCRIPTION 31
    • 2.3 MARKETS COVERED 33
    • 2.4 STAKEHOLDERS 34
    • 2.5 RESEARCH METHODOLOGY 35
      • 2.5.1 MARKET SIZE ESTIMATION 36
      • 2.5.2 MARKET BREAKDOWN AND DATA TRIANGULATION 39
      • 2.5.3 SECONDARY SOURCES 40
      • 2.5.4 PRIMARY SOURCES 41
      • 2.5.5 KEY DATA POINTS FROM SECONDARY SOURCES 41
      • 2.5.6 KEY DATA POINTS FROM PRIMARY SOURCES 42
      • 2.5.7 ASSUMPTIONS 42

    3 MARKET ANALYSIS 44

    • 3.1 INTRODUCTION 44
    • 3.2 MARKET SEGMENTATION 45
    • 3.3 FACTORS INFLUENCING MARKET 47
      • 3.3.1 DRIVERS AND OPPORTUNITIES 48
        • 3.3.1.1 Increasing incidence of heart failure 48
        • 3.3.1.2 Shortage of heart donors 49
        • 3.3.1.3 Technological advancements in VAD 49
        • 3.3.1.4 Rising geriatric population 50
        • 3.3.1.5 Vast pipeline products 50
        • 3.3.1.6 Increase in funding for CAD research 52
      • 3.3.2 RESTRAINTS AND THREATS 53
        • 3.3.2.1 Adverse events and complication with the implantations of CAD 53
        • 3.3.2.2 Cost of the devices 53
        • 3.3.2.3 Lack of skilled and trained professionals 54
        • 3.3.2.4 Stringent regulatory guidelines 55
        • 3.3.2.5 Availability of alternative products 55
        • 3.3.2.6 Cardiac assist devices product recalls due to FDA mandates 56
    • 3.4 REGULATORY AFFAIRS 57
      • 3.4.1 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION 57
      • 3.4.2 U.S. 58
      • 3.4.3 CANADA 60
      • 3.4.4 EUROPE 60
      • 3.4.5 CHINA 61
      • 3.4.6 JAPAN 63
      • 3.4.7 INDIA 64
    • 3.5 REIMBURSEMENT SCENARIO 65
      • 3.5.1 REIMBURSEMENT TABLE 66
        • 3.5.1.1 Ventricular assist device reimbursement 66
        • 3.5.1.2 CAD physician reimbursement 67
    • 3.6 UPCOMING TECHNOLOGY 69
    • 3.7 CLINICL TRIAL DATA 72
    • 3.8 PATENT TRENDS 76
    • 3.9 TECHNOLOGICAL ADVANCEMENTS 77
      • 3.9.1 INTRODUCTION 77
      • 3.9.2 PERCUTANEOUS VENTRICULAR ASSIST DEVICES (PVAD) 78
      • 3.9.3 MEDICAL COATINGS FOR CARDIAC ASSIST DEVICES 78
      • 3.9.4 ADVANCEMENT IN BLOOD FLOW TECHNOLOGY 79
    • 3.10 PORTER’S FIVE FORCE ANALYSIS 80
      • 3.10.1 THREAT OF NEW ENTRANTS 81
      • 3.10.2 THREAT OF SUBSTITUTES 82
      • 3.10.3 BARGAINING POWER OF SUPPLIERS 82
      • 3.10.4 BARGAINING POWER OF BUYERS 83
      • 3.10.5 COMPETITIVE RIVALRY 83
    • 3.11 SUPPLY CHAIN ANALYSIS 85
    • 3.12 MARKET SHARE ANALYSIS BY MAJOR PLAYERS 89
      • 3.12.1 CARDIAC ASSIST DEVICE GLOBAL MARKET SHARE ANALYSIS 89
      • 3.12.2 VENTRICULAR ASSIST DEVICE GLOBAL MARKET SHARE ANALYSIS 91
      • 3.12.3 INTRA-AORTIC BALLOON PUMP GLOBAL MARKET SHARE ANALYSIS 93
    • 3.13 CARDIAC ASSIST DEVICES NUMBER OF UNITS BY REGION 95
      • 3.13.1 VENTRICULAR ASSIST DEVICES NUMBER OF UNITS BY REGION 95
        • 3.13.1.1 Extracorporeal ventricular assist devices 96
        • 3.13.1.2 Intracorporeal ventricular assist devices 98
        • 3.13.1.3 Percutaneous ventricular assist devices 100
      • 3.13.2 TOTAL ARTIFICIAL HEART NUMBER OF UNITS BY REGION 102
    • 3.14 COMPARISON OF CARDIAC ASSIST DEVICES 104

    4 CARDIAC ASSIST DEVICES GLOBAL MARKET, BY PRODUCT 105

    • 4.1 INTRODUCTION 105
    • 4.2 VENTRICULAR ASSIST DEVICES (VAD) 108
      • 4.2.1 LEFT VENTRICULAR ASSIST DEVICES (LVAD) 113
      • 4.2.2 RIGHT VENTRICULAR ASSIST DEVICES (RVAD) 116
      • 4.2.3 BI-VENTRICULAR ASSIST DEVICES (BIVAD) 119
    • 4.3 INTRA-AORTIC BALLOON PUMPS (IABP) 122
    • 4.4 TOTAL ARTFICIAL HEART (TAH) 125

    5 CARDIAC ASSIST DEVICES GLOBAL MARKET, BY IMPLANT TYPE 128

    • 5.1 INTRODUCTION 128
    • 5.2 EXTRACORPOREAL OR PARACORPOREAL CAD 131
    • 5.3 INTRACORPOREAL CAD 134
    • 5.4 PERCUTANEOUS CAD 137

    6 CARDIAC ASSIST DEVICES GLOBAL MARKET, BY PUMP TYPE 140

    • 6.1 INTRODUCTION 140
    • 6.2 PULSATILE FLOW PUMP 144
    • 6.3 CONTINUOUS FLOW PUMP 147
      • 6.3.1 CENTRIFUGAL FLOW PUMP 152
      • 6.3.2 AXIAL FLOW PUMP 155

    7 CARDIAC ASSIST DEVICES GLOBAL MARKET, BY PATIENT TYPE 158

    • 7.1 INTRODUCTION 158
    • 7.2 PEDIATRIC CAD 161
    • 7.3 ADULT CAD 164

    8 CARDIAC ASSIST DEVICES GLOBAL MARKET, BY APPLICATION 167

    • 8.1 INTRODUCTION 167
    • 8.2 BRIDGE TO TRANSPLANT (BTT) 170
    • 8.3 BRIDGE TO DESTINATION THERAPY (BTD) 173
    • 8.4 BRIDGE TO RECOVERY (BTR) 176

    9 CARDIAC ASSIST DEVICES GLOBAL MARKET, BY END-USERS 179

    • 9.1 INTRODUCTION 179
    • 9.2 HOSPITALS 182
    • 9.3 ACADEMICS & RESEARCH INSTITUTES 185
    • 9.4 OTHER END-USERS 187

    10 REGIONAL ANALYSIS 190

    • 10.1 INTRODUCTION 190
    • 10.2 NORTH AMERICA 193
      • 10.2.1 U.S. 208
      • 10.2.2 OTHERS 212
    • 10.3 EUROPE 215
      • 10.3.1 GERMANY 230
      • 10.3.2 FRANCE 233
      • 10.3.3 U.K. 236
      • 10.3.4 OTHERS 239
    • 10.4 APAC 242
      • 10.4.1 JAPAN 257
      • 10.4.2 CHINA 260
      • 10.4.3 INDIA 263
      • 10.4.4 OTHERS 266
    • 10.5 ROW 269
      • 10.5.1 BRAZIL 283
      • 10.5.2 REST OF LATIN AMERICA 286
      • 10.5.3 MIDDLE EAST AND OTHERS 289

    11 COMPANY DEVELOPMENTS 292

    • 11.1 INTRODUCTION 292
    • 11.2 APPROVALS 293
    • 11.3 ACQUISITIONS 299
    • 11.4 PARTNERSHIPS 302
    • 11.5 OTHER DEVELOPMENTS 303

    12 MAJOR COMPANIES 309

    • 12.1 ABBOTT LABORATORIES 309
      • 12.1.1 OVERVIEW 309
      • 12.1.2 FINANCIALS 310
      • 12.1.3 PRODUCT PORTFOLIO 312
      • 12.1.4 KEY DEVELOPMENTS 313
      • 12.1.5 BUSINESS STRATEGY 314
      • 12.1.6 SWOT ANALYSIS 315
    • 12.2 ABIOMED, INC. 316
      • 12.2.1 OVERVIEW 316
      • 12.2.2 FINANCIALS 317
      • 12.2.3 PRODUCT PORTFOLIO 318
      • 12.2.4 KEY DEVELOPMENTS 318
      • 12.2.5 BUSINESS STRATEGY 321
      • 12.2.6 SWOT ANALYSIS 322
    • 12.3 BERLIN HEART GMBH 323
      • 12.3.1 OVERVIEW 323
      • 12.3.2 FINANCIALS 323
      • 12.3.3 PRODUCT PORTFOLIO 323
      • 12.3.4 KEY DEVELOPMENTS 324
      • 12.3.5 BUSINESS STRATEGY 324
      • 12.3.6 SWOT ANALYSIS 325
    • 12.4 BIVACOR INC. 326
      • 12.4.1 OVERVIEW 326
      • 12.4.2 FINANCIALS 326
      • 12.4.3 PRODUCT PORTFOLIO 326
      • 12.4.4 KEY DEVELOPMNTS 326
      • 12.4.5 BUSINESS STRATEGY 327
      • 12.4.6 SWOT ANALYSIS 328
    • 12.5 CARMAT SA 329
      • 12.5.1 OVERVIEW 329
      • 12.5.2 FINANCIALS 329
      • 12.5.3 PRODUCT PORTFOLIO 329
      • 12.5.4 KEY DEVELOPMNTS 330
      • 12.5.5 BUSINESS STRATEGY 331
      • 12.5.6 SWOT ANALYSIS 332
    • 12.6 FRESENIUS MEDICAL CARE AG & CO. KGAA (XENIOS AG) 333
      • 12.6.1 OVERVIEW 333
      • 12.6.2 FINANCIALS 334
      • 12.6.3 PRODUCT PORTFOLIO 335
      • 12.6.4 KEY DEVELOPMNTS 336
      • 12.6.5 BUSINESS STRATEGY 336
      • 12.6.6 SWOT ANALYSIS 337
    • 12.7 GETINGE GROUP (MAQUET) 338
      • 12.7.1 OVERVIEW 338
      • 12.7.2 FINANCIALS 339
      • 12.7.3 PRODUCT PORTFOLIO 342
      • 12.7.4 KEY DEVELOPMENTS 343
      • 12.7.5 BUSINESS STRATEGY 343
      • 12.7.6 SWOT ANALYSIS 344
    • 12.8 MEDTRONIC, PLC 345
      • 12.8.1 OVERVIEW 345
      • 12.8.2 FINANCIALS 346
      • 12.8.3 PRODUCT PORTFOLIO 349
      • 12.8.4 KEY DEVELOPMENTS 350
      • 12.8.5 BUSINESS STRATEGY 351
      • 12.8.6 SWOT ANALYSIS 352
    • 12.9 RELIANTHEART INC. 353
      • 12.9.1 OVERVIEW 353
      • 12.9.2 FINANCIALS 353
      • 12.9.3 PRODUCT PORTFOLIO 353
      • 12.9.4 KEY DEVELOPMNTS 354
      • 12.9.5 BUSINESS STRATEGY 355
      • 12.9.6 SWOT ANALYSIS 356
    • 12.10 SYNCARDIA SYSTEMS, INC 357
      • 12.10.1 OVERVIEW 357
      • 12.10.2 FINANCIALS 358
      • 12.10.3 PRODUCT PORTFOLIO 358
      • 12.10.4 KEY DEVELOPMENTS 358
      • 12.10.5 BUSINESS STRATEGY 358
      • 12.10.6 SWOT ANALYSIS 359
    • 12.11 TELEFLEX INCORPORATED 360
      • 12.11.1 OVERVIEW 360
      • 12.11.2 FINANCIALS 361
      • 12.11.3 PRODUCT PORTFOLIO 364
      • 12.11.4 KEY DEVELOPMENTS 364
      • 12.11.5 BUSINESS STRATEGY 365
      • 12.11.6 SWOT ANALYSIS 366
    • 12.12 ZEON CORPORATION 367
      • 12.12.1 OVERVIEW 367
      • 12.12.2 FINANCIALS 368
      • 12.12.3 PRODUCT PORTFOLIO 369
      • 12.12.4 KEY DEVELOPMENTS 369
      • 12.12.5 BUSINESS STRATEGY 370

    The heart conditions are considered advanced or end stage heart failure, when conventional heart therapies and management strategies no longer work. The reduced ability of the heart to pump blood and maintain normal bodily function leads to heart failure. Heart transplantation is currently the preferred treatment for end-stage heart failure. The availability of donor hearts is insufficient to meet the required demand and many patients are not eligible for transplantation due to age and other health conditions. The Cardiac assist devices (CAD) i.e. VAD, TAH and IABP are used to treat various conditions related to heart such as end stage heart failure, refractory angina pectoris, post-cardiopulmonary bypass shock, myocardial infarction, myocarditis, etc. The ventricular assist device is a mechanical pump that supports heart function and blood flow by taking on the workload of the left ventricle, right ventricle or both left and right ventricles helping the heart to pump oxygenated blood to the rest of the body. The indication for VAD use is acute cardiogenic shock (post cardiac surgery, myocarditis and massive myocardial infarction) and chronic heart failure. An artificial heart (TAH) is a mechanical assist device for persons with biventricular heart failure and heart transplant candidate which replaces both native ventricles and all four chambers of heart, thereby eliminating the symptoms of cardiac insufficiency or heart failure. Intra-aortic balloon pump (IABP) is placed in aorta to help the heart to pump more blood by reducing the workload on the heart and improves the function of the left ventricle as this is the chamber that pumps blood into the aorta. IABP is used in conditions such as acute mitral valve regurgitation or severe heart failure, left ventricular failure, unstable angina, etc.
    According to IQ4I Analysis, CAD market is expected to grow at double digit CAGR to reach $4,255.5 million by 2024. Products of Cardiac assist devices market is segmented into Ventricular Assist Device {(Left Ventricular Assist Devices (LVAD), Right Ventricular Assist Devices (RVAD) and Biventricular Assist Devices (Bi-VAD)}, Total Artificial Heart (TAH) and Intra-Aortic Balloon Pump (IABP). CAD market by pump type is segmented into Pulsating or Pneumatic Pump and Continuous Flow Pump. The continuous flow pump is further segmented into Axial flow pump and Centrifugal flow pump. CAD market by implant type is segmented into Extracorporeal CAD, Intracorporeal CAD and Percutaneous CAD. CAD market by patient type is segmented into Adult and Pediatric CAD. Applications of Cardiac assist devices are segmented into Bridge to Transplant (BTT), Bridge to destination (BTD), Bridge to Recovery (BTR). End-User of Cardiac assist devices are segmented into hospitals, academics & research institutes and other End-user (catheterization labs and ambulatory settings).
    This report concentrates on Cardiac assist devices that are placed internally (VAD, TAH), externally (VAD) and percutaneously (VAD and IABP) for treating end-stage heart failure, cardiogenic shock, ventricular insufficiency, acute heart attack, intraoperative and postoperative cardiac procedures. The mechanical circulatory devices like extracorporeal membrane oxygenation (ECMO) or Heart lung machine and other cardiac assist devices like pacemakers and defibrillators are not considered in Cardiac assist devices global market report.
    Some of the key players of the Cardiac assist devices are Abbott Laboratories (U.S.), Medtronic PLC (Ireland), Abiomed (U.S.), Reliant Heart (U.S.), Fresenius Medical Care AG & Co. KGaA Care AG & Co. KGaA (Germany), Getinge Group (Sweden), Syncardia Systems, Inc (U.S.), Zeon Corporation (Japan), Teleflex Incorporated (U.S.), etc.
    The report provides an in-depth market analysis of the above-mentioned segments across the following regions:
    • North America
    o U.S.
    o Others
    • Europe
    o Germany
    o France
    o U.K.
    o Others
    • Asia-Pacific
    o Japan
    o China
    o India
    o Others
    • Rest of the World (RoW)
    o Brazil
    o Rest of Latin America
    o Middle East and others

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