Cardiac Rhythm Management Market Analysis, Size, Trends | Global | 2019-2025 | MedSuite

Table of Content

List of Figures XXII
LIST OF CHARTS XLI
EXECUTIVE SUMMARY 1
GLOBAL CARDIAC RHYTHM MANAGEMENT, ELECTROPHYSIOLOGY & CARDIAC ABLATION MARKET OVERVIEW 1
COMPETITIVE ANALYSIS 4
MARKET TRENDS 7
MARKET DEVELOPMENTS 9
PROCEDURE NUMBERS 12
MARKETS INCLUDED 13
REGIONS INCLUDED 14
VERSION HISTORY 16
RESEARCH METHODOLOGY 17
Step 1: Project Initiation & Team Selection 17
Step 2: Prepare Data Systems and Perform Secondary Research 20
Step 3: Preparation for Interviews & Questionnaire Design 22
Step 4: Performing Primary Research 23
Step 5: Research Analysis: Establishing Baseline Estimates 25
Step 6: Market Forecast and Analysis 26
Step 7: Identify Strategic Opportunities 28
Step 8: Final Review and Market Release 29
Step 9: Customer Feedback and Market Monitoring 30
DISEASE OVERVIEW 31
2.1 INTRODUCTION 31
2.2 TYPES OF ARRHYTHMIAS 32
2.2.11 Atrial Fibrillation 32
2.2.12 Bradycardia 33
2.2.13 Conduction Disorders 33
2.2.13.1 Bundle Branch Block 33
2.2.13.2 Heart Block 34
2.2.13.3 Long QT Syndrome (LQTS) 35
2.2.14 Premature Contractions: PACs and PVCs 35
2.2.15 Tachycardia 36
2.2.16 Ventricular Fibrillation 37
2.2.17 Other Rhythm Disorders 37
2.2.17.1 Adams-Stokes Disease 37
2.2.17.2 Atrial Flutter 38
2.2.17.3 Sick Sinus syndrome 38
2.2.17.4 Sinus Arrhythmia 38
2.2.17.5 Wolff-Parkinson-White Syndrome (WPW) 38
2.2.18 Types of Arrhythmia in Children 38
2.3 HEART FAILURE 39
2.4 CARDIAC ARREST 40
2.5 PATIENT DEMOGRAPHICS 41
2.5.11 Atrial Fibrillation 41
2.5.12 Bradycardia 41
2.5.13 Conduction Disorders 42
2.5.14 Premature Contractions – PACs and PVCs 43
2.5.15 Tachycardia 44
2.5.16 Ventricular Fibrillation 44
2.5.17 Other Rhythm Disorders 45
PRODUCT ASSESSMENT 46
3.1 INTRODUCTION 46
3.2 PRODUCT PORTFOLIOS 46
3.2.1 Pacemakers 46
3.2.2 Implantable Cardioverter Defibrillators (ICDs) 49
3.2.3 Cardiac Resynchronization Therapy (CRT) Devices 51
3.2.4 Cardiac Leads 53
3.2.5 External Defibrillators 55
3.2.6 Lab Systems 57
3.2.6.1 Introduction 57
3.2.6.2 3D Mapping Systems 57
3.2.6.3 EP Recording Systems 58
3.2.6.4 Remote Steering Systems 59
3.2.6.5 RF Ablation Generator 59
3.2.6.6 ICE Systems 59
3.2.6.7 Product Matrix for Lab Systems: Core Companies 61
3.2.7 Diagnostic EP Catheters 62
3.2.7.1 Introduction 62
3.2.7.2 Diagnostic EP Catheters 62
3.2.7.3 ICE Catheters 63
3.2.8 Cardiac Ablation Catheters 66
3.2.8.1 Introduction 66
3.2.8.2 RF Ablation Catheters 67
3.2.8.3 Alternative Energy Catheters 68
3.2.8.4 High Intensity Focused Ultrasound 68
3.3 FDA RECALLS 71
3.3.1 Abbott 71
3.3.1.1 Pacemakers 71
3.3.1.2 Implantable Cardioverter Defibrillators (ICDs) 72
3.3.1.3 Cardiac Resynchronization Therapy (CRT) Devices 73
3.3.1.4 Cardiac Leads 74
3.3.1.5 EP Lab Devices 74
3.3.1.6 Cardiac Ablation Catheter 75
3.3.2 Biosense Webster 76
3.3.2.1 EP Lab Devices 76
3.3.3 Boston Scientific 77
3.3.3.1 Pacemakers 77
3.3.3.2 Implantable Cardioverter Defibrillators (ICDs) 83
3.3.3.3 Cardiac Resynchronization Therapy (CRT) Devices 84
3.3.3.4 Cardiac Leads 87
3.3.3.5 EP Lab Devices 87
3.3.3.6 RF Ablation Catheter 88
3.3.4 Cardiac Science 89
3.3.4.1 Automated External Defibrillator (AED) 89
3.3.5 Medtronic 90
3.3.5.1 Pacemakers 90
3.3.5.2 Implantable Cardioverter Defibrillators (ICDs) 91
3.3.5.3 Cardiac Resynchronization Therapy (CRT) Devices 94
3.3.5.4 Cardiac Leads 97
3.3.5.5 EP Lab Devices 97
3.3.6 MicroPort 98
3.3.6.1 Implantable Cardioverter Defibrillators (ICDs) 98
3.3.6.2 Cardiac Resynchronization Therapy (CRT) Devices 100
3.3.7 Philips Healthcare 102
3.3.7.1 Automated External Defibrillator (AED) 102
3.3.8 Stryker Sustainability Solutions 104
3.3.8.1 Diagnostic EP Catheters 104
3.3.9 ZOLL 106
3.3.9.1 Automated External Defibrillator (AED) 106
3.3.9.2 Wearable Cardioverter Defibrillator (WCD) 106
3.4 CLINICAL TRIALS 107
3.4.1 Pacemakers 107
3.4.2 Implantable Cardioverter Defibrillators (ICDs) 111
3.4.3 Cardiac Resynchronization Therapy (CRT) Devices 114
3.4.4 Cardiac Leads 119
3.4.5 External Defibrillators 125
3.4.6 Lab Systems 126
3.4.6.1 3D Mapping Systems 126
3.4.6.2 EP Recording Systems 128
3.4.6.3 RF Ablation Generators 129
3.4.6.4 ICE Systems 130
3.4.7 Diagnostic EP Catheters 132
3.4.7.1 Diagnostic Catheter 132
3.4.8 Cardiac Ablation Catheter 134
3.4.8.1 RF Ablation Catheters 134
3.4.8.2 Cryoablation Catheters 137
3.4.8.3 Laser Ablation Catheters 143
GLOBAL CARDIAC RHYTHM MANAGEMENT, ELECTROPHYSIOLOGY & CARDIAC ABLATION MARKET OVERVIEW 145
4.1 INTRODUCTION 145
4.2 MARKET OVERVIEW 147
4.3 TREND ANALYSIS BY SEGMENT 152
4.4 DRIVERS AND LIMITERS 155
4.4.1 Market Drivers 155
4.4.2 Market Limiters 157
4.5 COMPETITIVE MARKET SHARE ANALYSIS 160
4.6 MERGERS AND ACQUISITIONS 164
4.7 COMPANY PROFILES 165
4.7.1 Abbott 165
4.7.2 Biosense Webster 166
4.7.3 Biotronik 167
4.7.4 Boston Scientific 168
4.7.5 Cardiac Science 170
4.7.6 GE Healthcare 171
4.7.7 Medtronic 172
4.7.8 MicroPort 173
4.7.9 ZOLL 175
4.8 SWOT ANALYSIS 176
4.8.1 Abbott 176
4.8.2 Biosense Webster 178
4.8.3 Biotronik 179
4.8.4 Boston Scientific 180
4.8.5 Cardiac Science 181
4.8.6 GE Healthcare 182
4.8.7 Medtronic 183
4.8.8 MicroPort 184
4.8.9 ZOLL 186
PROCEDURE NUMBERS 187
5.1 INTRODUCTION 187
5.2 PROCEDURES 188
5.2.1 Global Procedures 188
5.2.2 North America Procedures 190
5.2.2.1 Canada 192
5.2.2.2 U.S. 192
5.2.3 Latin America Procedures 193
5.2.3.1 Argentina 195
5.2.3.2 Brazil 195
5.2.3.3 Chile 196
5.2.3.4 Colombia 196
5.2.3.5 Jamaica 197
5.2.3.6 Mexico 197
5.2.3.7 Peru 198
5.2.3.8 Venezuela 198
5.2.3.9 Rest of Latin America 199
5.2.4 Western Europe Procedures 200
5.2.4.1 Austria 202
5.2.4.2 Benelux 202
5.2.4.3 France 203
5.2.4.4 Germany 203
5.2.4.5 Italy 204
5.2.4.6 Portugal 204
5.2.4.7 Scandinavia 205
5.2.4.8 Spain 205
5.2.4.9 Switzerland 206
5.2.4.10 United Kingdom 206
5.2.4.11 Rest of Western Europe 207
5.2.5 Central & Eastern Europe Procedures 208
5.2.5.1 Baltic States 210
5.2.5.2 Bulgaria 210
5.2.5.3 Croatia 211
5.2.5.4 Czech Republic 211
5.2.5.5 Greece 212
5.2.5.6 Hungary 212
5.2.5.7 Kazakhstan 213
5.2.5.8 Poland 213
5.2.5.9 Romania 214
5.2.5.10 Russia 214
5.2.5.11 Turkey 215
5.2.5.12 Ukraine 215
5.2.5.13 Rest of Central & Eastern Europe 216
5.2.6 Middle East Procedures 217
5.2.6.1 Bahrain 219
5.2.6.2 Iran 219
5.2.6.3 Israel 220
5.2.6.4 Kuwait 220
5.2.6.5 Oman 221
5.2.6.6 Qatar 221
5.2.6.7 Saudi Arabia 222
5.2.6.8 United Arab Emirates 222
5.2.6.9 Rest of Middle East 223
5.2.7 Asia-Pacific Procedures 224
5.2.7.1 Australia 226
5.2.7.2 Brunei 226
5.2.7.3 Cambodia 227
5.2.7.4 China 227
5.2.7.5 Hong Kong 228
5.2.7.6 India 228
5.2.7.7 Indonesia 229
5.2.7.8 Japan 229
5.2.7.9 Malaysia 230
5.2.7.10 Myanmar 230
5.2.7.11 New Zealand 231
5.2.7.12 Singapore 231
5.2.7.13 South Korea 232
5.2.7.14 Taiwan 232
5.2.7.15 Thailand 233
5.2.7.16 The Philippines 233
5.2.7.17 Vietnam 234
5.2.7.18 Rest of Asia Pacific 234
5.2.8 Africa Procedures 235
5.2.8.1 Algeria 237
5.2.8.2 Egypt 237
5.2.8.3 Ghana 238
5.2.8.4 Kenya 238
5.2.8.5 Libya 239
5.2.8.6 Morocco 239
5.2.8.7 Nigeria 240
5.2.8.8 South Africa 240
5.2.8.9 Sudan 241
5.2.8.10 Uganda 241
5.2.8.11 Rest of Africa 242
NORTH AMERICA MARKET 243
6.1 INTRODUCTION 243
6.1.1 Countries Included 244
6.2 MARKET OVERVIEW 245
6.3 MARKET ANALYSIS AND FORECAST 250
6.3.1 Total Pacemaker Market 250
6.3.1.1.1 Single and Dual-Chamber Devices 250
6.3.1.1.2 MRI-Compatible Pacemaker 251
6.3.1.1.3 Initial Placement and Replacement of Pacemakers 251
6.3.1.2 Market Overview 252
6.3.1.3 Total Single-Chamber Pacemaker Market 255
6.3.1.3.1 New Placement Single-Chamber Pacemaker Market 257
6.3.1.3.2 Replacement Single-Chamber Pacemaker Market 258
6.3.1.4 Total Dual-Chamber Pacemaker Market 259
6.3.1.4.1 New Placement Dual-Chamber Pacemaker Market 261
6.3.1.4.2 Replacement Dual-Chamber Pacemaker Market 262
6.3.2 Total Implantable Cardiac Defibrillator Market 263
6.3.2.1.1 Cardiac Resynchronization Therapy-Defibrillators 264
6.3.2.2 Market Overview 265
6.3.2.3 Total Single-Chamber ICD Market 268
6.3.2.3.1 New Placement Single-Chamber ICD Market 270
6.3.2.3.2 Replacement Single-Chamber ICD Market 271
6.3.2.4 Total Dual-Chamber ICD Market 272
6.3.2.4.1 New Placement Dual-Chamber ICD Market 274
6.3.2.4.2 Replacement Dual-Chamber ICD Market 275
6.3.3 Total Cardiac Resynchronization Therapy Market 276
6.3.3.1.1 Cardiac Resynchronization Therapy-Pacemakers (CRT-Ps) 276
6.3.3.1.2 Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) 276
6.3.3.2 Market Overview 277
6.3.3.3 Total CRT-P Market 280
6.3.3.3.1 New Placement CRT-P Market 282
6.3.3.3.2 Replacement CRT-P Market 283
6.3.3.4 Total CRT-D Market 284
6.3.3.4.1 New Placement CRT-D Market 286
6.3.3.4.2 Replacement CRT-D Market 287
6.3.4 Total Cardiac Lead Market 288
6.3.4.1.1 Replacement of Leads 289
6.3.4.2 Market Overview 290
6.3.4.3 Pacing Lead Market 292
6.3.4.4 Defibrillation Lead Market 293
6.3.4.5 LV Lead Market 294
6.3.5 Total Lab Systems Market 295
6.3.5.1.1 3D Mapping Systems 295
6.3.5.1.2 EP Recording Systems 296
6.3.5.1.3 Remote Steering Systems 296
6.3.5.2 Market Overview 297
6.3.5.3 3D Mapping System Market 299
6.3.5.4 EP Recording System Market 300
6.3.6 Diagnostic EP Catheter Market 301
6.3.6.1.1 Diagnostic Electrophysiology Catheters 301
6.3.6.1.2 Intracardiac Echocardiography 301
6.3.6.2 Market Overview 302
6.3.7 Cardiac Ablation Catheter Market 305
6.3.7.1.1 Alternative Arrhythmia Treatments 305
6.3.7.1.2 Atrial Fibrillation 306
6.3.7.2 Market Overview 307
LATIN AMERICA MARKET 309
7.1 INTRODUCTION 309
7.1.1 Countries Included 310
7.2 MARKET OVERVIEW 311
7.3 MARKET ANALYSIS AND FORECAST 316
7.3.1 Total Pacemaker Market 316
7.3.1.1.1 Single and Dual-Chamber Devices 316
7.3.1.1.2 MRI-Compatible Pacemaker 317
7.3.1.1.3 Initial Placement and Replacement of Pacemakers 317
7.3.1.2 Market Overview 318
7.3.1.3 Total Single-Chamber Pacemaker Market 321
7.3.1.3.1 New Placement Single-Chamber Pacemaker Market 323
7.3.1.3.2 Replacement Single-Chamber Pacemaker Market 324
7.3.1.4 Total Dual-Chamber Pacemaker Market 325
7.3.1.4.1 New Placement Dual-Chamber Pacemaker Market 327
7.3.1.4.2 Replacement Dual-Chamber Pacemaker Market 328
7.3.2 Total Implantable Cardiac Defibrillator Market 329
7.3.2.1.1 Cardiac Resynchronization Therapy-Defibrillators 330
7.3.2.2 Market Overview 331
7.3.2.3 Total Single-Chamber ICD Market 334
7.3.2.3.1 New Placement Single-Chamber ICD Market 336
7.3.2.3.2 Replacement Single-Chamber ICD Market 337
7.3.2.4 Total Dual-Chamber ICD Market 338
7.3.2.4.1 New Placement Dual-Chamber ICD Market 340
7.3.2.4.2 Replacement Dual-Chamber ICD Market 341
7.3.3 Total Cardiac Resynchronization Therapy Market 342
7.3.3.1.1 Cardiac Resynchronization Therapy-Pacemakers (CRT-Ps) 342
7.3.3.1.2 Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) 342
7.3.3.2 Market Overview 343
7.3.3.3 Total CRT-P Market 346
7.3.3.3.1 New Placement CRT-P Market 348
7.3.3.3.2 Replacement CRT-P Market 349
7.3.3.4 Total CRT-D Market 350
7.3.3.4.1 New Placement CRT-D Market 352
7.3.3.4.2 Replacement CRT-D Market 353
7.3.4 Total Cardiac Lead Market 354
7.3.4.1.1 Replacement of Leads 355
7.3.4.2 Market Overview 356
7.3.4.3 Pacing Lead Market 358
7.3.4.4 Defibrillation Lead Market 359
7.3.4.5 LV Lead Market 360
7.3.5 Total Lab Systems Market 361
7.3.5.1.1 3D Mapping Systems 361
7.3.5.1.2 EP Recording Systems 362
7.3.5.1.3 Remote Steering Systems 362
7.3.5.2 Market Overview 363
7.3.5.3 3D Mapping System Market 365
7.3.5.4 EP Recording System Market 366
7.3.6 Diagnostic EP Catheter Market 367
7.3.6.1.1 Diagnostic Electrophysiology Catheters 367
7.3.6.1.2 Intracardiac Echocardiography 367
7.3.6.2 Market Overview 368
7.3.7 Cardiac Ablation Catheter Market 371
7.3.7.1.1 Alternative Arrhythmia Treatments 371
7.3.7.1.2 Atrial Fibrillation 372
7.3.7.2 Market Overview 373
WESTERN EUROPE MARKET 375
8.1 INTRODUCTION 375
8.1.1 Countries Included 376
8.2 MARKET OVERVIEW 377
8.3 MARKET ANALYSIS AND FORECAST 382
8.3.1 Total Pacemaker Market 382
8.3.1.1.1 Single and Dual-Chamber Devices 382
8.3.1.1.2 MRI-Compatible Pacemaker 383
8.3.1.1.3 Leadless Pacemaker 383
8.3.1.1.4 Initial Placement and Replacement of Pacemakers 383
8.3.1.2 Market Overview 385
8.3.1.3 Total Single-Chamber Pacemaker Market 388
8.3.1.3.1 New Placement Single-Chamber Pacemaker Market 390
8.3.1.3.2 Replacement Single-Chamber Pacemaker Market 391
8.3.1.4 Total Dual-Chamber Pacemaker Market 392
8.3.1.4.1 New Placement Dual-Chamber Pacemaker Market 394
8.3.1.4.2 Replacement Dual-Chamber Pacemaker Market 395
8.3.2 Total Implantable Cardiac Defibrillator Market 396
8.3.2.1.1 Cardiac Resynchronization Therapy-Defibrillators 397
8.3.2.2 Market Overview 398
8.3.2.3 Total Single-Chamber ICD Market 401
8.3.2.3.1 New Placement Single-Chamber ICD Market 403
8.3.2.3.2 Replacement Single-Chamber ICD Market 404
8.3.2.4 Total Dual-Chamber ICD Market 405
8.3.2.4.1 New Placement Dual-Chamber ICD Market 407
8.3.2.4.2 Replacement Dual-Chamber ICD Market 408
8.3.3 Total Cardiac Resynchronization Therapy Market 409
8.3.3.1.1 Cardiac Resynchronization Therapy-Pacemakers (CRT-Ps) 409
8.3.3.1.2 Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) 409
8.3.3.2 Market Overview 410
8.3.3.3 Total CRT-P Market 413
8.3.3.3.1 New Placement CRT-P Market 415
8.3.3.3.2 Replacement CRT-P Market 416
8.3.3.4 Total CRT-D Market 417
8.3.3.4.1 New Placement CRT-D Market 419
8.3.3.4.2 Replacement CRT-D Market 420
8.3.4 Total Cardiac Lead Market 421
8.3.4.1.1 Replacement of Leads 422
8.3.4.2 Market Overview 423
8.3.4.2.1 Pacing Lead Market 425
8.3.4.2.2 Defibrillation Lead Market 426
8.3.4.2.3 LV Lead Market 427
8.3.5 Total Lab Systems Market 428
8.3.5.1.1 3D Mapping Systems 428
8.3.5.1.2 EP Recording Systems 429
8.3.5.1.3 Remote Steering Systems 429
8.3.5.2 Market Overview 430
8.3.5.3 3D Mapping System Market 432
8.3.5.4 EP Recording System Market 433
8.3.6 Diagnostic EP Catheter Market 434
8.3.6.1.1 Diagnostic Electrophysiology Catheters 434
8.3.6.1.2 Intracardiac Echocardiography 434
8.3.6.2 Market Overview 435
8.3.7 Cardiac Ablation Catheter Market 438
8.3.7.1.1 Alternative Arrhythmia Treatments 438
8.3.7.1.2 Atrial Fibrillation 439
8.3.7.2 Market Overview 440
CENTRAL & EASTERN EUROPE MARKET 442
9.1 INTRODUCTION 442
9.1.1 Countries Included 443
9.2 MARKET OVERVIEW 444
9.3 MARKET ANALYSIS AND FORECAST 449
9.3.1 Total Pacemaker Market 449
9.3.1.1.1 Single and Dual-Chamber Devices 449
9.3.1.1.2 MRI-Compatible Pacemaker 450
9.3.1.1.3 Initial Placement and Replacement of Pacemakers 450
9.3.1.2 Market Overview 451
9.3.1.3 Total Single-Chamber Pacemaker Market 454
9.3.1.3.1 New Placement Single-Chamber Pacemaker Market 456
9.3.1.3.2 Replacement Single-Chamber Pacemaker Market 457
9.3.1.4 Total Dual-Chamber Pacemaker Market 458
9.3.1.4.1 New Placement Dual-Chamber Pacemaker Market 460
9.3.1.4.2 Replacement Dual-Chamber Pacemaker Market 461
9.3.2 Total Implantable Cardiac Defibrillator Market 462
9.3.2.1.1 Cardiac Resynchronization Therapy-Defibrillators 463
9.3.2.2 Market Overview 464
9.3.2.3 Total Single-Chamber ICD Market 467
9.3.2.3.1 New Placement Single-Chamber ICD Market 469
9.3.2.3.2 Replacement Single-Chamber ICD Market 470
9.3.2.4 Total Dual-Chamber ICD Market 471
9.3.2.4.1 New Placement Dual-Chamber ICD Market 473
9.3.2.4.2 Replacement Dual-Chamber ICD Market 474
9.3.3 Total Cardiac Resynchronization Therapy Market 475
9.3.3.1.1 Cardiac Resynchronization Therapy-Pacemakers (CRT-Ps) 475
9.3.3.1.2 Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) 475
9.3.3.2 Market Overview 476
9.3.3.3 Total CRT-P Market 479
9.3.3.3.1 New Placement CRT-P Market 481
9.3.3.3.2 Replacement CRT-P Market 482
9.3.3.4 Total CRT-D Market 483
9.3.3.4.1 New Placement CRT-D Market 485
9.3.3.4.2 Replacement CRT-D Market 486
9.3.4 Total Cardiac Lead Market 487
9.3.4.1.1 Replacement of Leads 488
9.3.4.2 Market Overview 489
9.3.4.3 Pacing Lead Market 491
9.3.4.4 Defibrillation Lead Market 492
9.3.4.5 LV Lead Market 493
9.3.5 Total Lab Systems Market 494
9.3.5.1.1 3D Mapping Systems 494
9.3.5.1.2 EP Recording Systems 495
9.3.5.1.3 Remote Steering Systems 495
9.3.5.2 Market Overview 496
9.3.5.3 3D Mapping System Market 498
9.3.5.4 EP Recording System Market 499
9.3.6 Diagnostic EP Catheter Market 500
9.3.6.1.1 Diagnostic Electrophysiology Catheters 500
9.3.6.1.2 Intracardiac Echocardiography 500
9.3.6.2 Market Overview 501
9.3.7 Cardiac Ablation Catheter Market 504
9.3.7.1.1 Alternative Arrhythmia Treatments 504
9.3.7.1.2 Atrial Fibrillation 505
9.3.7.2 Market Overview 506
MIDDLE EAST MARKET 508
10.1 INTRODUCTION 508
10.1.1 Countries Included 509
10.2 MARKET OVERVIEW 510
10.3 MARKET ANALYSIS AND FORECAST 515
10.3.1 Total Pacemaker Market 515
10.3.1.1.1 Single and Dual-Chamber Devices 515
10.3.1.1.2 MRI-Compatible Pacemaker 516
10.3.1.1.3 Initial Placement and Replacement of Pacemakers 516
10.3.1.2 Market Overview 517
10.3.1.3 Total Single-Chamber Pacemaker Market 520
10.3.1.3.1 New Placement Single-Chamber Pacemaker Market 522
10.3.1.3.2 Replacement Single-Chamber Pacemaker Market 523
10.3.1.4 Total Dual-Chamber Pacemaker Market 524
10.3.1.4.1 New Placement Dual-Chamber Pacemaker Market 526
10.3.1.4.2 Replacement Dual-Chamber Pacemaker Market 527
10.3.2 Total Implantable Cardiac Defibrillator Market 528
10.3.2.1.1 Cardiac Resynchronization Therapy-Defibrillators 529
10.3.2.2 Market Overview 530
10.3.2.3 Total Single-Chamber ICD Market 533
10.3.2.3.1 New Placement Single-Chamber ICD Market 535
10.3.2.3.2 Replacement Single-Chamber ICD Market 536
10.3.2.4 Total Dual-Chamber ICD Market 537
10.3.2.4.1 New Placement Dual-Chamber ICD Market 539
10.3.2.4.2 Replacement Dual-Chamber ICD Market 540
10.3.3 Total Cardiac Resynchronization Therapy Market 541
10.3.3.1.1 Cardiac Resynchronization Therapy-Pacemakers (CRT-Ps) 541
10.3.3.1.2 Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) 541
10.3.3.2 Market Overview 542
10.3.3.3 Total CRT-P Market 545
10.3.3.3.1 New Placement CRT-P Market 547
10.3.3.3.2 Replacement CRT-P Market 548
10.3.3.4 Total CRT-D Market 549
10.3.3.4.1 New Placement CRT-D Market 551
10.3.3.4.2 Replacement CRT-D Market 552
10.3.4 Total Cardiac Lead Market 553
10.3.4.1.1 Replacement of Leads 554
10.3.4.2 Market Overview 555
10.3.4.3 Pacing Lead Market 557
10.3.4.4 Defibrillation Lead Market 558
10.3.4.5 LV Lead Market 559
10.3.5 Total Lab Systems Market 560
10.3.5.1.1 3D Mapping Systems 560
10.3.5.1.2 EP Recording Systems 561
10.3.5.1.3 Remote Steering Systems 561
10.3.5.2 Market Overview 562
10.3.5.3 3D Mapping System Market 564
10.3.5.4 EP Recording System Market 565
10.3.6 Diagnostic EP Catheter Market 566
10.3.6.1.1 Diagnostic Electrophysiology Catheters 566
10.3.6.1.2 Intracardiac Echocardiography 566
10.3.6.2 Market Overview 567
10.3.7 Cardiac Ablation Catheter Market 570
10.3.7.1.1 Alternative Arrhythmia Treatments 570
10.3.7.1.2 Atrial Fibrillation 571
10.3.7.2 Market Overview 572
ASIA-PACIFIC MARKET 574
11.1 INTRODUCTION 574
11.1.1 Countries Included 575
11.2 MARKET OVERVIEW 576
11.3 MARKET ANALYSIS AND FORECAST 581
11.3.1 Total Pacemaker Market 581
11.3.1.1.1 Single and Dual-Chamber Devices 581
11.3.1.1.2 MRI-Compatible Pacemaker 582
11.3.1.1.3 Initial Placement and Replacement of Pacemakers 582
11.3.1.2 Market Overview 583
11.3.1.3 Total Single-Chamber Pacemaker Market 586
11.3.1.3.1 New Placement Single-Chamber Pacemaker Market 588
11.3.1.3.2 Replacement Single-Chamber Pacemaker Market 589
11.3.1.4 Total Dual-Chamber Pacemaker Market 590
11.3.1.4.1 New Placement Dual-Chamber Pacemaker Market 592
11.3.1.4.2 Replacement Dual-Chamber Pacemaker Market 593
11.3.2 Total Implantable Cardiac Defibrillator Market 594
11.3.2.1.1 Cardiac Resynchronization Therapy-Defibrillators 595
11.3.2.2 Market Overview 596
11.3.2.3 Total Single-Chamber ICD Market 599
11.3.2.3.1 New Placement Single-Chamber ICD Market 601
11.3.2.3.2 Replacement Single-Chamber ICD Market 602
11.3.2.4 Total Dual-Chamber ICD Market 603
11.3.2.4.1 New Placement Dual-Chamber ICD Market 605
11.3.2.4.2 Replacement Dual-Chamber ICD Market 606
11.3.3 Total Cardiac Resynchronization Therapy Market 607
11.3.3.1.1 Cardiac Resynchronization Therapy-Pacemakers (CRT-Ps) 607
11.3.3.1.2 Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) 607
11.3.3.2 Market Overview 608
11.3.3.3 Total CRT-P Market 611
11.3.3.3.1 New Placement CRT-P Market 613
11.3.3.3.2 Replacement CRT-P Market 614
11.3.3.4 Total CRT-D Market 615
11.3.3.4.1 New Placement CRT-D Market 617
11.3.3.4.2 Replacement CRT-D Market 618
11.3.4 Total Cardiac Lead Market 619
11.3.4.1.1 Replacement of Leads 620
11.3.4.2 Market Overview 621
11.3.4.3 Pacing Lead Market 623
11.3.4.4 Defibrillation Lead Market 624
11.3.4.5 LV Lead Market 625
11.3.5 Total Lab Systems Market 626
11.3.5.1.1 3D Mapping Systems 626
11.3.5.1.2 EP Recording Systems 627
11.3.5.1.3 Remote Steering Systems 627
11.3.5.2 Market Overview 628
11.3.5.3 3D Mapping System Market 630
11.3.5.4 EP Recording System Market 631
11.3.6 Diagnostic EP Catheter Market 632
11.3.6.1.1 Diagnostic Electrophysiology Catheters 632
11.3.6.1.2 Intracardiac Echocardiography 632
11.3.6.2 Market Overview 633
11.3.7 Cardiac Ablation Catheter Market 636
11.3.7.1.1 Alternative Arrhythmia Treatments 636
11.3.7.1.2 Atrial Fibrillation 637
11.3.7.2 Market Overview 638
AFRICA MARKET 640
12.1 INTRODUCTION 640
12.1.1 Countries Included 641
12.2 MARKET OVERVIEW 642
12.3 MARKET ANALYSIS AND FORECAST 647
12.3.1 Total Pacemaker Market 647
12.3.1.1.1 Single and Dual-Chamber Devices 647
12.3.1.1.2 MRI-Compatible Pacemaker 648
12.3.1.1.3 Initial Placement and Replacement of Pacemakers 648
12.3.1.2 Market Overview 649
12.3.1.3 Total Single-Chamber Pacemaker Market 652
12.3.1.3.1 New Placement Single-Chamber Pacemaker Market 654
12.3.1.3.2 Replacement Single-Chamber Pacemaker Market 655
12.3.1.4 Total Dual-Chamber Pacemaker Market 656
12.3.1.4.1 New Placement Dual-Chamber Pacemaker Market 658
12.3.1.4.2 Replacement Dual-Chamber Pacemaker Market 659
12.3.2 Total Implantable Cardiac Defibrillator Market 660
12.3.2.1.1 Cardiac Resynchronization Therapy-Defibrillators 661
12.3.2.2 Market Overview 662
12.3.2.3 Total Single-Chamber ICD Market 665
12.3.2.3.1 New Placement Single-Chamber ICD Market 667
12.3.2.3.2 Replacement Single-Chamber ICD Market 668
12.3.2.4 Total Dual-Chamber ICD Market 669
12.3.2.4.1 New Placement Dual-Chamber ICD Market 671
12.3.2.4.2 Replacement Dual-Chamber ICD Market 672
12.3.3 Total Cardiac Resynchronization Therapy Market 673
12.3.3.1.1 Cardiac Resynchronization Therapy-Pacemakers (CRT-Ps) 673
12.3.3.1.2 Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) 673
12.3.3.2 Market Overview 674
12.3.3.3 Total CRT-P Market 677
12.3.3.3.1 New Placement CRT-P Market 679
12.3.3.3.2 Replacement CRT-P Market 680
12.3.3.4 Total CRT-D Market 681
12.3.3.4.1 New Placement CRT-D Market 683
12.3.3.4.2 Replacement CRT-D Market 684
12.3.4 Total Cardiac Lead Market 685
12.3.4.1.1 Replacement of Leads 686
12.3.4.2 Market Overview 687
12.3.4.3 Pacing Lead Market 689
12.3.4.4 Defibrillation Lead Market 690
12.3.4.5 LV Lead Market 691
12.3.5 Total Lab Systems Market 692
12.3.5.1.1 3D Mapping Systems 692
12.3.5.1.2 EP Recording Systems 693
12.3.5.1.3 Remote Steering Systems 693
12.3.5.2 Market Overview 694
12.3.5.3 3D Mapping System Market 696
12.3.5.4 EP Recording System Market 697
12.3.6 Diagnostic EP Catheter Market 698
12.3.6.1.1 Diagnostic Electrophysiology Catheters 698
12.3.6.1.2 Intracardiac Echocardiography 698
12.3.6.2 Market Overview 699
12.3.7 Cardiac Ablation Catheter Market 702
12.3.7.1.1 Alternative Arrhythmia Treatments 702
12.3.7.1.2 Atrial Fibrillation 703
12.3.7.2 Market Overview 704
ABBREVIATIONS 706

List of Figures

Figure 1-1: Cardiac Rhythm Management, Electrophysiology & Cardiac Ablation Market Share Ranking by
Segment, Global, 2018 ................................................................................................................................. 5
Figure 1-2: Companies Researched in this Report, Global, 2018 .................................................................. 6
Figure 1-3: Factors Impacting the Cardiac Rhythm Management, Electrophysiology & Cardiac Ablation
Market by Segment, Global (1 of 2) ............................................................................................................. 7
Figure 1-4: Factors Impacting the Cardiac Rhythm Management, Electrophysiology & Cardiac Ablation
Market by Segment, U.S. (2 of 2) ................................................................................................................. 8
Figure 1-5: Recent Events in the Cardiac Rhythm Management, Electrophysiology & Cardiac Ablation
Market, Global, 2015 – 2019 (1 of 3) ........................................................................................................... 9
Figure 1-6: Recent Events in the Cardiac Rhythm Management, Electrophysiology & Cardiac Ablation
Market, Global, 2015 – 2019 (2 of 3) ......................................................................................................... 10
Figure 1-7: Recent Events in the Cardiac Rhythm Management, Electrophysiology & Cardiac Ablation
Market, Global, 2015 – 2019 (3 of 3) ......................................................................................................... 11
Figure 1-8: Cardiac Rhythm Management, Electrophysiology & Cardiac Ablation Procedures Covered Global ......................................................................................................................................................... 12
Figure 1-9: CRM & EP Markets Covered, Global ......................................................................................... 13
Figure 1-10: CRM & EP Regions Covered, Global (1 of 2) ............................................................................ 14
Figure 1-11: CRM & EP Regions Covered, Global (2 of 2) ............................................................................ 15
Figure 1-12: Version History ........................................................................................................................ 16
Figure 3-1: Pacemaker Market Products by Company .......................................................................... 48
Figure 3-2: ICD Market Products by Company ....................................................................................... 50
Figure 3-3: CRT Device Market Products by Company .......................................................................... 52
Figure 3-4: Cardiac Leads Market Products by Company ..................................................................... 54
Figure 3-5: External Defibrillator Market Products by Company ........................................................ 56
Figure 3-6: Lab Systems Market Products by Company ........................................................................ 61
Figure 3-7: Diagnostic EP Catheter Market Products by Company ..................................................... 65
Figure 3-8: Cardiac Ablation Catheter Products by Company (1 of 2) ................................................ 69
Figure 3-9: Cardiac Ablation Catheter Products by Company (2 of 2) ................................................ 70 Figure 3-10: Class 2 Device Recall Assurity.................................................................................................. 71
Figure 3-11: Class 2 Device Recall Zenex ..................................................................................................... 71
Figure 3-12: Class 2 Device Recall Accent family of pacemakers ................................................................ 71
Figure 3-13: Class 1 Device Recall Fortify, Fortify Assura ............................................................................ 72
Figure 3-14: Class 1 Device Recall Fortify, Unify, Assura, including Quadra ............................................... 72
Figure 3-15: Class 2 Device Recall Ellipse .................................................................................................... 73
Figure 3-16: Class 2 Device Recall Allure Quadra ........................................................................................ 73
Figure 3-17: Class 2 Device Recall Anthem, Allure ...................................................................................... 73
Figure 3-18: Class 2 Device Recall Nuance .................................................................................................. 74
Figure 3-19: Class 1 Device Recall Optisure HV lead ................................................................................... 74
Figure 3-20: Class 3 Device Recall FIRMap 60mm Catheter ........................................................................ 74
Figure 3-21: Class 2 Device Recall TactiSys Quartz Pack, PN004 400 .......................................................... 75
Figure 3-22: Class 2 Device Recall SMARTABLATE RF Generator System ................................................... 76
Figure 3-23: Class 2 Device Recall ESSENTIO Pacemaker ............................................................................ 77
Figure 3-24: Class 2 Device Recall PROPONENT Pacemaker ....................................................................... 77
Figure 3-25: Class 2 Device Recall ACCOLADE Pacemaker .......................................................................... 77
Figure 3-26: Class 2 Device Recall PROPONENT SR Pacemaker .................................................................. 78
Figure 3-27: Class 2 Device Recall PROPONENT DR Pacemaker .................................................................. 78
Figure 3-28: Class 2 Device Recall PROPONENT EL DR Pacemaker ............................................................. 78
Figure 3-29: Class 2 Device Recall PROPONENT VDD SL Pacemaker ........................................................... 78
Figure 3-30: Class 2 Device Recall PROPONENT VDD SL Pacemaker ........................................................... 79
Figure 3-31: Class 2 Device Recall ACCOLADE MRI EL DR Pacemaker ......................................................... 79
Figure 3-32: Class 2 Device Recall ACCOLADE MRI DR Pacemaker ............................................................. 79
Figure 3-33: Class 2 Device Recall ACCOLADE MRI SR Pacemaker .............................................................. 79
Figure 3-34: Class 2 Device Recall ACCOLADE EL DR Pacemaker ................................................................ 80
Figure 3-35: Class 2 Device Recall ACCOLADE DR Pacemaker ..................................................................... 80
Figure 3-36: Class 2 Device Recall ACCOLADE SR Pacemaker ..................................................................... 80
Figure 3-37: Class 2 Device Recall ESSENTIO MRI EL DR Pacemaker .......................................................... 80
Figure 3-38: Class 2 Device Recall ESSENTIO MRI DR Pacemaker ............................................................... 81
Figure 3-39: Class 2 Device Recall ESSENTIO MRI SR Pacemaker ................................................................ 81
Figure 3-40: Class 2 Device Recall ESSENTIO DR Pacemaker ...................................................................... 81
Figure 3-41: Class 2 Device Recall ESSENTIO SR Pacemaker ....................................................................... 81 Figure 3-42: Class 2 Device Recall ALTRUA 2 EL DR Pacemaker .................................................................. 82
Figure 3-43: Class 2 Device Recall ALTRUA 2 SR Pacemaker ....................................................................... 82
Figure 3-44: Class 2 Device Recall ALTRUA 2 DR Pacemaker ...................................................................... 82
Figure 3-45: Class 2 Device Recall Accolade MRI and Essentio MRI pacemakers ....................................... 82
Figure 3-46: Class 2 Device Recall Implantable Cardioverter Defibrillator (NonCRT) ................................. 83
Figure 3-47: Class 2 Device Recall RESONATE EL ICD VR ............................................................................. 83
Figure 3-48: Class 2 Device Recall RESONATE EL ICD DR ............................................................................. 83
Figure 3-49: Class 2 Device Recall EMBLEM SICD, Model A209 .................................................................. 83
Figure 3-50: Class 2 Device Recall SQRX 1010 Pulse Generator .................................................................. 84
Figure 3-51: Class 2 Device Recall EMBLEM MRI SICD Model 219 .............................................................. 84
Figure 3-52: Class 2 Device Recall SQRX Model 1010 Subcutaneous Pulse Generator .............................. 84
Figure 3-53: Class 2 Device Recall VISIONIST X4 CRTP (Cardiac Resynchronization Therapy Pacemaker) . 84
Figure 3-54: Class 2 Device Recall VALITUDE X4 CRTP (Cardiac Resynchronization Therapy Pacemaker) . 85
Figure 3-55: Class 2 Device Recall VALITUDE X4 CRTP Pacemaker ............................................................. 85
Figure 3-56: Class 2 Device Recall VALITUDE CRTP Pacemaker .................................................................. 85
Figure 3-57: Class 2 Device Recall VISIONIST X4 CRTP Pacemaker ............................................................. 85
Figure 3-58: Class 2 Device Recall VISIONIST CRTP Pacemaker .................................................................. 86
Figure 3-59: Class 2 Device Recall VALITUDE X4 CRTP Pacemaker ............................................................. 86
Figure 3-60: Class 2 Device Recall RESONATE X4 CRTD ............................................................................... 86
Figure 3-61: Class 2 Device Recall MOMENTUM X4 CRTD .......................................................................... 86
Figure 3-62: Class 2 Device Recall VIGILANT X4 CRTD ................................................................................. 87
Figure 3-63: Class 2 Device Recall Boston Scientific, INGEVITY MRI Leads, Sterile EO, RxOnly .................. 87
Figure 3-64: Class 2 Device Recall Maestro 4000 Cardiac Ablation System ................................................ 87
Figure 3-65: Class 2 Device Recall CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System ...... 88
Figure 3-66: Class 3 Device Recall Cardiac Ablation Percutaneous Catheters ............................................ 88
Figure 3-67: Class 1 Device Recall Intella Tip MiFi Open Irrigated Ablation Catheter ................................ 88
Figure 3-68: Class 2 Device Recall 9131 Defibrillator Electrodes ................................................................ 89
Figure 3-69: Class 2 Device Recall Medtronic Model 53401 Single Chamber External Pulse Generator.... 90
Figure 3-70: Class 2 Device Recall Medtronic Model 5392 Dual Chamber Temporary External Pulse
Generator ................................................................................................................................................... 90
Figure 3-71: Class 2 Device Recall EnTrust Dual Chamber Implantable Cardioverter Defibrillator with
Atrial and Ventricular Therapies ................................................................................................................ 91 Figure 3-72: Class 2 Device Recall EnTrust Single Chamber Implantable Cardioverter Defibrillator with
Atrial and Ventricular Therapies ................................................................................................................ 91
Figure 3-73: Class 2 Device Recall Medtronic EnTrust Escudo .................................................................... 92
Figure 3-74: Class 1 Device Recall Evera MRI XT DR ICD, Evera MRI XT VR ICD, Evera MRI S DR ICD ......... 92
Figure 3-75: Class 1 Device Recall Visia AF MRI VR SureScan ICD ............................................................... 92
Figure 3-76: Class 1 Device Recall Visia AF VR ICD ...................................................................................... 93
Figure 3-77: Class 1 Device Recall Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD ...... 93
Figure 3-78: Class 2 Device Recall Evera ICD ............................................................................................... 93
Figure 3-79: Class 2 Device Recall Viva ICD ................................................................................................. 94
Figure 3-80: Class 2 Device Recall Percepta CRTP MRI SureScan ................................................................ 94
Figure 3-81: Class 2 Device Recall Percepta Quad CRTP MRI SureScan ...................................................... 94
Figure 3-82: Class 1 Device Recall Amplia MRI CRTD, Amplia MRI Quad CRTD .......................................... 95
Figure 3-83: Class 1 Device Recall Viva Quad S CRTD, Viva Quad XT CRTD, Viva S CRTD, Viva XT CRTD .... 95
Figure 3-84: Class 1 Device Recall Compia MRI CRTD, Compia MRI Quad CRTD ........................................ 96
Figure 3-85: Class 2 Device Recall Amplia MRI Quad CRT0 SureScanClaria MRI Quad CRTD
SureScanCompia MRI Quad CRTD SureScan .............................................................................................. 96
Figure 3-86: Class 2 Device Recall InSync III ................................................................................................ 96
Figure 3-87: Class 2 Device Recall Medtronic, Temporary Pacing Lead System ......................................... 97
Figure 3-88: Class 2 Device Recall Achieve Electrical Cable ........................................................................ 97
Figure 3-89: Class 2 Device Recall Medtronic CryoConsole ........................................................................ 97
Figure 3-90: Class 2 Device Recall Platinium DR 1510 ................................................................................. 98
Figure 3-91: Class 2 Device Recall Platinium VR 1210 ................................................................................. 98
Figure 3-92: Class 2 Device Recall Platinium DR DF4 1540 ......................................................................... 98
Figure 3-93: Class 2 Device Recall Platinium VR DF4 1240 .......................................................................... 99
Figure 3-94: Class 2 Device Recall PARADYM .............................................................................................. 99
Figure 3-95: Class 2 Device Recall OVATIO .................................................................................................. 99
Figure 3-96: Class 2 Device Recall INTENSIA ............................................................................................... 99
Figure 3-97: Class 2 Device Recall Platinium Implantable Cardiac Defibrillator and Resynchronization
Therapy Defibrillator ................................................................................................................................ 100
Figure 3-98: Class 2 Device Recall Platinium CRTD 1741 .......................................................................... 100
Figure 3-99: Class 2 Device Recall Platinium CRT DF1 1711 ...................................................................... 100
Figure 3-100: Class 2 Device Recall PARADYM .......................................................................................... 101 Figure 3-101: Class 2 Device Recall OVATIO .............................................................................................. 101
Figure 3-102: Class 2 Device Recall INTENSIA ........................................................................................... 101
Figure 3-103: Class 2 Device Recall HeartStart MRx Monitor/Defibrillator .............................................. 102
Figure 3-104: Class 2 Device Recall Philips HeartStart FRx AED ................................................................ 102
Figure 3-105: Class 2 Device Recall Philips HeartStart (HS1) (Onsite/Home) AED .................................... 102
Figure 3-106: Class 3 Device Recall XL Defibrillator .................................................................................. 103
Figure 3-107: Class 2 Device Recall Philips QCPR Meter CPR feedback device ......................................... 103
Figure 3-108: Class 2 Device Recall HeartStart MRx Monitor/Defibrillator .............................................. 103
Figure 3-109: Class 2 Device Recall Philips HeartStart .............................................................................. 103
Figure 3-110: Class 2 Device Recall BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter ............... 104
Figure 3-111: Class 2 Device Recall Reprocessed LASSO NAV eco Electrophysiology Catheter ............... 104
Figure 3-112: Class 2 Device Recall Reprocessed Coronary Sinus Diagnostic EP Catheter ....................... 104
Figure 3-113: Class 2 Device Recall Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco
Variable Diagnostic .................................................................................................................................. 105
Figure 3-114: Class 2 Device Recall Stryker Sustainability Solutions......................................................... 105
Figure 3-115: Class 2 Device Recall Daig Livewire Steerable and Supreme Fixed Curve Diagnostic
Electrophysiology Catheters .................................................................................................................... 105
Figure 3-116: Class 2 Class 2 Device Recall OneStep CPR Complete ......................................................... 106
Figure 3-117: Class 2 Device Recall LifeVest Wearable Defibrillator ........................................................ 106
Figure 3-118: SJM Brady MRI Post Approval Study ................................................................................... 108
Figure 3-119: Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular
Block Patients After Pacemaker Implantation (AF-pacemaker Study) .................................................... 109
Figure 3-120: Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers
................................................................................................................................................................. 109
Figure 3-121: Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan ...................... 109
Figure 3-122: BIO|MASTER.Edora Family Study ....................................................................................... 110
Figure 3-123: China Micra Transcatheter Pacing Study ............................................................................ 110
Figure 3-124: Optimizing Pacemaker Therapy Using Multi-Point Pacing (the OPT-MPP Study) .............. 110
Figure 3-125: Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation in Over 65s - The
CAPAPAF-65 Study ................................................................................................................................... 111
Figure 3-126: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II ...................... 111
Figure 3-127: Observation of ImageReady? MR Conditional Pacing System in China ............................. 111 Figure 3-128: Micra Transcatheter Pacing System Continued Access Study Protocol .............................. 112
Figure 3-129: Comparison of CRT-D and CRT-DX Systems (CRT-NEXT) ..................................................... 112
Figure 3-130: Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients with the Use
of a VDD-ICD Lead (Dx-AF) ....................................................................................................................... 113
Figure 3-131: Multicenter Automatic Defibrillator Implantation Trial with Subcutaneous Implantable
Cardioverter Defibrillator (MADIT S-ICD) ................................................................................................ 113
Figure 3-132: Extravascular ICD Pilot Study .............................................................................................. 113
Figure 3-133: Acute Feasibility Investigation of a New S-ICD Electrode Arrangement for Reduction of
Defibrillation Energies.............................................................................................................................. 114
Figure 3-134: Subcutaneous ICD Therapy Combined with VT Ablation for the Secondary Prevention of
Sudden Cardiac Death.............................................................................................................................. 114
Figure 3-135: BIO|MASTER.Ilivia Family/Plexa ......................................................................................... 114
Figure 3-136: The REACT-ICD Trial (REACT-ICD) ........................................................................................ 115
Figure 3-137: Prospective Randomized Trial Comparing TRIPLE Site ventricular Stimulation Versus
Conventional Pacing in CRT candidates: TRIPLEAD Trial ......................................................................... 115
Figure 3-138: Can Cognitive Function be Improved by Cardiac Resynchronization Therapy? (COGNI-CRT)
................................................................................................................................................................. 116
Figure 3-139: Re-evaluation of Optimal Re-synchronization Therapy in Patients with Chronic Heart Failure
- An Investigator-driven, Prospective, Parallel-group, Randomized, Open, Blinded Outcome Assessment
(PROBE), Multi-center Trial Without Investigational Medical Products (Proof of Strategy Trial) ........... 116
Figure 3-140: Continued Access Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization
Algorithm in the Paradym RF SonR CRT-D ............................................................................................... 117
Figure 3-141: AV Optimization Delivered with Direct His Bundle Pacing, in Patients with Heart Failure Long PR Without Left Bundle Branch Block: Randomized Multi-center Clinical Outcome Study. .......... 117
Figure 3-142: Heart Failure with Preserved Ejection Fraction Treated by Cardiac Resynchronization
Therapy Versus Rate Responsive Pacing: A Mechanistic Study ............................................................... 118
Figure 3-143: Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy
(Randomized Trial) ................................................................................................................................... 118
Figure 3-144: Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients
(BIO|PULSE) ............................................................................................................................................. 118
Figure 3-145: A Multicentre Randomized Control Trial Comparing Standard Cardiac Resynchronization
Pacing with Triventricular Pacing ............................................................................................................. 119 Figure 3-146: Responders and Quadripolar LV Lead in CRT ...................................................................... 119
Figure 3-147: Does Targeted LV Lead Positioning Towards Latest Local Electric Activation at CRT
Implantation Reduce Incidence of the Combined Endpoint "Death or Non-planned Hospitalization for
Heart Failure (HF)" in Patients with HF and Prolonged QRS .................................................................... 120
Figure 3-148: Plexa ICD Lead Registry ....................................................................................................... 120
Figure 3-149: AXONE -Acute: Safety and Electrical Performance Evaluation of INVICTA Leads Models
Equipped with DF4 Connector ................................................................................................................. 121
Figure 3-150: Safety and Electrical Performances Evaluation of Navigo Leads Equipped with IS4
Connector (NAVIGATOR) ......................................................................................................................... 121
Figure 3-151: Avoid Transvenous Leads in Appropriate Subjects ............................................................. 122
Figure 3-152: Left Ventricular Septal Pacing: Potential Application for Cardiac Resynchronization Therapy
................................................................................................................................................................. 122
Figure 3-153: Quartet Lead and Resynchronization Therapy Options - Assessing the Response Rate at 6
Months in CRT Patients Implanted with a Quartet Left Ventricular (LV) Quadripolar Lead and the
MultiPoint Pacing (MPP) Feature Activated ............................................................................................ 123
Figure 3-154: Attain Stability? Quad Clinical Study .................................................................................. 123
Figure 3-155: Imaging Study of Lead Implant for His Bundle Pacing ((IMAGE-HBP)) ............................... 124
Figure 3-156: The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Persistent Atrial
Fibrillation ................................................................................................................................................ 124
Figure 3-157: Reverse RAMP Pacing to Terminate Ventricular Tachycardia (REV-RAMP) ....................... 124
Figure 3-158: AXONE -Acute: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac
Resynchronization Therapy ..................................................................................................................... 125
Figure 3-159: A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD
Undergoing Magnetic Resonance Imaging, an Investigational Device Exemption (IDE) Study ............... 125
Figure 3-160: Acute Extravascular Defibrillation Study ............................................................................. 125
Figure 3-161: Quality of Cardiopulmonary Resuscitation Guided by AED vs Telephone-assistance ........ 126
Figure 3-162: Accuracy of Instructional Diagrams for Automated External Defibrillator (AED) Pad
Positioning ............................................................................................................................................... 126
Figure 3-163: RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) ........................ 127
Figure 3-164: Esophageal 3D Mapping System for Cardiac Arrhythmias: Pilot Study to Establish Basis for
Improved Arrhythmia Diagnostics Using the esoECG-3D Catheter ......................................................... 127
Figure 3-165: Real-time Electrogram Analysis for Drivers of AtRial Fibrillation (RADAR) ......................... 128 Figure 3-166: EnSite? HD Grid Catheter Mapping System for Advanced High Density Three-Dimensional
Mapping in Non-Paroxysmal Atrial Fibrillation and Atrial Tachycardia ................................................... 128
Figure 3-167: Clinical Utility and Validation of the Rhythmia Mapping System for the Treatment of
Cardiac Arrhythmias ................................................................................................................................ 129
Figure 3-168: Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD)
Detection Algorithm Performance Assessment ...................................................................................... 129
Figure 3-169: Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String
Defibrillator (ISSD) Development ............................................................................................................ 130
Figure 3-170: Advanced Cardiac Therapeutics DiamondTemp TempeRAture-Controlled and Contact
Sensing RF Ablation Clinical Trial for Atrial Fibrillation ............................................................................ 130
Figure 3-171: Visualization of Human Cardiovascular Anatomy With Foresight Intracardiac
Echocardiography (ICE) System ............................................................................................................... 131
Figure 3-172: INtra-procedural ultraSound Imaging for DEtermination of Atrial Wall Thickness and Acute
Tissue Changes During Isolation of the Pulmonary Veins ....................................................................... 131
Figure 3-173: EnSite Precision? Cardiac Mapping System and EnSite Precision? Software v2.0
Observational Registry ............................................................................................................................. 132
Figure 3-174: Visualization of Human Cardiovascular Anatomy With Foresight Intracardiac
Echocardiography (ICE) System ............................................................................................................... 132
Figure 3-175: Esophageal 3D Mapping System for Cardiac Arrhythmias: Pilot Study to Establish Basis for
Improved Arrhythmia Diagnostics Using the esoECG-3D Catheter ......................................................... 133
Figure 3-176: EnSite? HD Grid Catheter Mapping System for Advanced High Density Three-Dimensional
Mapping in Non-Paroxysmal Atrial Fibrillation and Atrial Tachycardia ................................................... 133
Figure 3-177: DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness ........ 134
Figure 3-178: FIRE AND ICE II Trial Pilot .................................................................................................... 135
Figure 3-179: Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon
Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR) .......................... 135
Figure 3-180: Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL
SMARTTOUCH? SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal
Atrial Fibrillation ...................................................................................................................................... 136
Figure 3-181: Microfidelity (MIFI) Ablation Technology Versus Standard Ablation Catheter for
Atrioventricular Nodal Ablation A Comparative Pilot Study of Time to Success ..................................... 136
Figure 3-182: Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter . 137