世界の心臓ペースメーカー市場:医療機器パイプライン分析2016

◆英語タイトル:Cardiac Pacemakers - Medical Devices Pipeline Assessment, 2016
◆商品コード:GDME0210EPD
◆発行会社(調査会社):GlobalData
◆発行日:2016年7月4日
◆ページ数:125
◆レポート言語:英語
◆レポート形式:PDF
◆納品方法:Eメール
◆調査対象地域:グローバル
◆産業分野:医療機器
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当調査レポートでは、心臓ペースメーカーのグローバル製品パイプライン動向について調査・分析し、以下の構成でお届けいたします。
・心臓ペースメーカーの概要
・心臓ペースメーカーの開発動向:開発段階別分析
・心臓ペースメーカーの開発動向:セグメント別分析
・心臓ペースメーカーの開発動向:領域別分析
・心臓ペースメーカーの開発動向:規制Path別分析
・心臓ペースメーカーの開発動向:承認日(推定)別分析
・企業別心臓ペースメーカーの開発動向(パイプライン製品、進行中の治験)
・心臓ペースメーカーの最近動向
【レポートの概要】

Cardiac Pacemakers – Medical Devices Pipeline Assessment, 2016

Summary

GlobalData’s Medical Devices sector report, “Cardiac Pacemakers – Medical Devices Pipeline Assessment, 2016″ provides an overview of Cardiac Pacemakers currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Cardiac Pacemakers pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData’s team of industry experts.

*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

- Extensive coverage of the Cardiac Pacemakers under development
- The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities
- The report reviews the major players involved in the development of Cardiac Pacemakers and list all their pipeline projects
- The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
- The report provides key clinical trial data of ongoing trials specific to pipeline products
- Recent developments in the segment / industry

Reasons to buy

The report enables you to –
- Formulate significant competitor information, analysis, and insights to improve R&D strategies
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Identify and understand important and diverse types of Cardiac Pacemakers under development
- Develop market-entry and market expansion strategies
- Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline
- In-depth analysis of the product’s current stage of development, territory and estimated launch date

【レポートの目次】

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 7
2 Introduction 8
2.1 Cardiac Pacemakers Overview 8
3 Products under Development 9
3.1 Cardiac Pacemakers – Pipeline Products by Stage of Development 9
3.2 Cardiac Pacemakers – Pipeline Products by Segment 10
3.3 Cardiac Pacemakers – Pipeline Products by Territory 11
3.4 Cardiac Pacemakers – Pipeline Products by Regulatory Path 12
3.5 Cardiac Pacemakers – Pipeline Products by Estimated Approval Date 13
3.6 Cardiac Pacemakers – Ongoing Clinical Trials 14
4 Cardiac Pacemakers – Pipeline Products under Development by Companies 15
4.1 Cardiac Pacemakers Companies – Pipeline Products by Stage of Development 15
4.2 Cardiac Pacemakers – Pipeline Products by Stage of Development 16
5 Cardiac Pacemakers Companies and Product Overview 17
5.1 Boston Scientific Corporation Company Overview 17
5.1.1 Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 17
5.2 Boston TransTec, LLC Company Overview 21
5.2.1 Boston TransTec, LLC Pipeline Products & Ongoing Clinical Trials Overview 21
5.3 Duke University Company Overview 22
5.3.1 Duke University Pipeline Products & Ongoing Clinical Trials Overview 22
5.4 EBR Systems, Inc. Company Overview 23
5.4.1 EBR Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 23
5.5 Hadasit Medical Research Services & Development Ltd Company Overview 27
5.5.1 Hadasit Medical Research Services & Development Ltd Pipeline Products & Ongoing Clinical Trials Overview 27
5.6 InnerPulse, Inc. Company Overview 29
5.6.1 InnerPulse, Inc. Pipeline Products & Ongoing Clinical Trials Overview 29
5.7 Kenergy Inc. Company Overview 30
5.7.1 Kenergy Inc. Pipeline Products & Ongoing Clinical Trials Overview 30
5.8 Krisara Engineering, LLC Company Overview 31
5.8.1 Krisara Engineering, LLC Pipeline Products & Ongoing Clinical Trials Overview 31
5.9 LivaNova PLC Company Overview 32
5.9.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 32
5.10 Mathematical Bio-Solutions Inc. Company Overview 39
5.10.1 Mathematical Bio-Solutions Inc. Pipeline Products & Ongoing Clinical Trials Overview 39
5.11 Mayo Clinic US Company Overview 40
5.11.1 Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 40
5.12 Medtronic plc Company Overview 41
5.12.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 41
5.13 MicroPort Scientific Corporation Company Overview 47
5.13.1 MicroPort Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 47
5.14 NDSU Research Foundation Company Overview 48
5.14.1 NDSU Research Foundation Pipeline Products & Ongoing Clinical Trials Overview 48
5.15 NuVascular Technologies Inc Company Overview 49
5.15.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 49
5.16 Perpetuum Ltd. Company Overview 50
5.16.1 Perpetuum Ltd. Pipeline Products & Ongoing Clinical Trials Overview 50
5.17 St. Jude Medical, Inc. Company Overview 51
5.17.1 St. Jude Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 51
5.18 University of Bern Company Overview 57
5.18.1 University of Bern Pipeline Products & Ongoing Clinical Trials Overview 57
5.19 University of California, Los Angeles Company Overview 58
5.19.1 University of California, Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 58
5.20 University of Michigan Company Overview 59
5.20.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 59
6 Cardiac Pacemakers – Recent Developments 60
6.1 Jul 01, 2016: BIOTRONIK Pacemakers that Automatically Adapt to MRI Environments Get CE Approval 60
6.2 Jun 30, 2016: NuVasive Agrees to Settle Patent Litigation With Medtronic 60
6.3 Jun 27, 2016: Greatbatch Renamed Integer Holdings 61
6.4 Jun 21, 2016: Texas Cardiac Arrhythmia Institute at St. David’s Medical Center First in Texas to Use Micra Transcatheter Pacing System Post FDA Approval 61
6.5 Jun 09, 2016: New Data Further Demonstrate Safety Benefits for World’s Smallest Pacemaker 62
6.6 Jun 08, 2016: Boston Scientific Announces Restructuring Program to Support Long-Term Growth and Innovation 63
6.7 Jun 06, 2016: Medtronic Outlines Future Growth Vision at Investor Day 64
6.8 May 31, 2016: Medtronic Reports Fourth Quarter and Fiscal Year 2016 Financial Results 64
6.9 May 26, 2016: Northwestern Medicine Cardiologist First in Illinois to Implant World’s Smallest FDA-Approved Pacemaker 67
6.10 May 10, 2016: AVX releases MQ Series medical grade MLCCs 67
6.11 May 06, 2016: New Data Showcases the Long-Term Clinical Benefits of the Nanostim Leadless Pacemaker Compared to Traditional Pacemakers 68
6.12 May 05, 2016: New Data Further Support Medtronic Leadership in Leadless Pacing at Heart Rhythm 2016 69
6.13 May 05, 2016: St. Jude Medical Announces MultiPoint Pacing IDE Study Results During Late-Breaker at Heart Rhythm 2016 70
6.14 May 05, 2016: The Parkview Mirro Center for Research and Innovation Initiates Study to Demonstrate Value of Personalized Patient Engagement for Those Suffering from Heart Failure 71
6.15 May 04, 2016: Medtronic Welcomes Karen L. Parkhill as Its New Chief Financial Officer 72
6.16 Apr 28, 2016: Greatbatch Reports 2016 First Quarter Results 73
6.17 Apr 27, 2016: Abbott Labs to Acquire St. Jude Medical for up to USD25 Billion 75
6.18 Apr 20, 2016: St. Jude Medical Reports First Quarter 2016 Results 76
6.19 Apr 18, 2016: Material in Medtronic Leads Inducted into Space Technology Hall of Fame 77
6.20 Apr 13, 2016: Nihon Kohden Evolves Brand, Website to Meet Needs of Changing Healthcare Environment 78
6.21 Apr 06, 2016: FDA approves first leadless pacemaker to treat heart rhythm disorders 78
6.22 Apr 06, 2016: Medtronic Statement on U.S. Department of Treasury’s Recent Temporary and Proposed Regulations 79
6.23 Mar 17, 2016: Medtronic Proposes Proxy Access 79
6.24 Mar 10, 2016: St. Jude Medical Secures CE Mark Approval of MRI Compatibility for the Nanostim Leadless Pacemaker 80
6.25 Mar 08, 2016: EBR Systems Announces First Commercial Implants of WiSE Technology 81
6.26 Mar 01, 2016: Medtronic Reports Third Quarter Financial Results 82
6.27 Feb 29, 2016: Greatbatch Reports 2015 Fourth Quarter and Full Year Results 83
6.28 Feb 19, 2016: Medtronic to Announce Financial Results for Its Third Quarter of Fiscal Year 2016 86
6.29 Feb 18, 2016: FDA Panel Provides Leadership and Guidance to Companies Seeking to Advance Leadless Pacing Technology in the U.S. 86
6.30 Feb 03, 2016: Nihon Kohden America Receives Great Place to Work Certification 87
6.31 Jan 29, 2016: Medtronic To Present Data On Micra Transcatheter Pacing System At Upcoming FDA Advisory Committee Meeting 87
6.32 Jan 28, 2016: LivaNova Receives Regulatory Approval in Japan for KORA 250 88
6.33 Jan 27, 2016: St. Jude Medical Reports Fourth Quarter and Full-Year 2015 Results 88
6.34 Jan 26, 2016: Greatbatch Awarded $37.5 Million in Patent Infringement Lawsuit Against AVX 91
6.35 Jan 13, 2016: St. Jude Medical Announces Preliminary Fourth Quarter 2015 Financial Results 91
6.36 Jan 11, 2016: Medtronic Updates Capital Allocation Plans and Fiscal 2016 EPS Guidance 92
6.37 Jan 11, 2016: Greatbatch Provides Preliminary 2015 Revenue Results and 2016 Guidance 93
6.38 Dec 14, 2015: The Medtronic Bakken Invitation Award Honors 12 Patients from Around the World for Giving Back 93
6.39 Dec 01, 2015: World’s Only Company to Offer Japan’s ICD and Pacemaker Patients 3 Tesla MRI Access 94
6.40 Nov 20, 2015: Medtronic Statement on U.S. Department of Treasury’s Notice 2015-79 95
6.41 Nov 18, 2015: Latest Cardiac Advancements from Medtronic Win 2015 ‘Best of What’s New’ Awards from Popular Science 95
6.42 Nov 09, 2015: World’s Smallest Pacemaker, Medtronic Micra TPS, Meets Global Clinical Trial’s Safety and Effectiveness Endpoints 95
6.43 Nov 09, 2015: BIOTRONIK Affirms Commitment to Physician Education at Forum Featuring World Leading Electrophysiologists 97
6.44 Oct 29, 2015: Greatbatch Reports 2015 Third Quarter Results 97
6.45 Oct 21, 2015: St. Jude Medical Reports Third Quarter 2015 Results 100
6.46 Oct 13, 2015: Greatbatch Raises USD360 Million in Private Placement of 9.125% Notes Due 2023 101
6.47 Oct 05, 2015: EBR Systems Receives European CE Mark Approval for World’s First Wireless Cardiac Pacing System for Heart Failure 102
6.48 Sep 28, 2015: Medtronic InFuse Lawsuit May Reach Supreme Court, Parker Waichman LLP Comments 103
6.49 Sep 14, 2015: Incoming St. Jude Medical President and CEO Mike Rousseau Announces Executive Leadership Team 103
6.50 Sep 10, 2015: Sorin and Cyberonics Announce Appointment of LivaNova’s Chief Financial Officer 104
6.51 Sep 09, 2015: St. Jude Medical Announces Leadership Transition Plan 104
6.52 Sep 08, 2015: No Further Legal Action By Italian State’s Attorney To Enjoin The Combination Of Sorin And Cyberonics 106
6.53 Sep 03, 2015: Medtronic Reports First Quarter Financial Results 106
6.54 Aug 30, 2015: St. Jude Medical Presents Nanostim’s Primary Results From Leadless II Study 109
6.55 Aug 26, 2015: Greatbatch Partners with Wireless Power Leader WiTricity to Provide Wireless Charging for Medical Devices 109
6.56 Aug 07, 2015: Financial Results for the First Quarter of Fiscal Year Ending March 31, 2016 110
6.57 Aug 05, 2015: St. Jude Medical Appoints David Dvorak to Its Board of Directors 112
6.58 Jul 31, 2015: Consolidated Financial Results for the 1st Quarter of the Fiscal Year Ending March 31, 2016 112
6.59 Jul 30, 2015: Greatbatch Reports 2015 Second Quarter Results 113
6.60 Jul 30, 2015: Sorin Group Announces Results for the Second Quarter of 2015 116
6.61 Jul 27, 2015: Sorin And Cyberonics Announce Intent To Vigorously Contest Claim By Italian State’s Attorney Seeking To Enjoin The Proposed Combination Of The Companies 118
6.62 Jul 22, 2015: St. Jude Medical Reports Second Quarter 2015 Results 119
6.63 Jul 14, 2015: Malaysia, The Hub Of Medical Device Manufacturing In Asean 120
7 Appendix 122
7.1 Methodology 122
7.2 About GlobalData 124
7.3 Contact Us 125
7.4 Disclaimer 125

1.1 List of Tables
Table 1: Cardiac Pacemakers - Pipeline Products by Stage of Development 9
Table 2: Cardiac Pacemakers - Pipeline Products by Segment 10
Table 3: Cardiac Pacemakers - Pipeline Products by Territory 11
Table 4: Cardiac Pacemakers - Pipeline Products by Regulatory Path 12
Table 5: Cardiac Pacemakers - Pipeline Products by Estimated Approval Date 13
Table 6: Cardiac Pacemakers - Ongoing Clinical Trials 14
Table 7: Pacemakers Companies - Pipeline Products by Stage of Development 15
Table 8: Cardiac Pacemakers - Pipeline Products by Stage of Development 16
Table 9: Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 17
Table 10: EMPOWER Modular Pacing System - Product Status 17
Table 11: EMPOWER Modular Pacing System - Product Description 18
Table 12: INGENIO 2 PG - MICS - Product Status 18
Table 13: INGENIO 2 PG - MICS - Product Description 18
Table 14: Boston Scientific Corporation - Ongoing Clinical Trials Overview 19
Table 15: INGENIO 2 PG - MICS - Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P) 20
Table 16: Boston TransTec, LLC Pipeline Products & Ongoing Clinical Trials Overview 21
Table 17: Raul Pacemaker - Product Status 21
Table 18: Raul Pacemaker - Product Description 21
Table 19: Duke University Pipeline Products & Ongoing Clinical Trials Overview 22
Table 20: Tissue-Engineered Autonomous Pacemaker - Product Status 22
Table 21: Tissue-Engineered Autonomous Pacemaker - Product Description 22
Table 22: EBR Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 23
Table 23: Second Generation Wireless Pacing System - Product Status 23
Table 24: Second Generation Wireless Pacing System - Product Description 23
Table 25: WiSE System - Product Status 24
Table 26: WiSE System - Product Description 24
Table 27: EBR Systems, Inc. - Ongoing Clinical Trials Overview 25
Table 28: WiSE System - WiCS-LV Post Market Surveillance Registry 26
Table 29: Hadasit Medical Research Services & Development Ltd Pipeline Products & Ongoing Clinical Trials Overview 27
Table 30: Aortic Pacemaker - Product Status 27
Table 31: Aortic Pacemaker - Product Description 28
Table 32: InnerPulse, Inc. Pipeline Products & Ongoing Clinical Trials Overview 29
Table 33: InnerPulse Pacemaker - Product Status 29
Table 34: InnerPulse Pacemaker - Product Description 29
Table 35: Kenergy Inc. Pipeline Products & Ongoing Clinical Trials Overview 30
Table 36: Unconditional MRI Compatible Implantable Pacemaker - Product Status 30
Table 37: Unconditional MRI Compatible Implantable Pacemaker - Product Description 30
Table 38: Krisara Engineering, LLC Pipeline Products & Ongoing Clinical Trials Overview 31
Table 39: Wireless Pacemaker - Product Status 31
Table 40: Wireless Pacemaker - Product Description 31
Table 41: LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 32
Table 42: KORA 100 Pacing System - Product Status 32
Table 43: KORA 100 Pacing System - Product Description 33
Table 44: REPLY 200 DR - Product Status 33
Table 45: REPLY 200 DR - Product Description 34
Table 46: REPLY 200 SR - Product Status 34
Table 47: REPLY 200 SR - Product Description 35
Table 48: Reply MRI Pacemaker - Product Status 35
Table 49: Reply MRI Pacemaker - Product Description 35
Table 50: LivaNova PLC - Ongoing Clinical Trials Overview 36
Table 51: REPLY 200 SR - Sustainability of Cardiology Services: Economic Evaluation and Communication in Remote Monitoring of People with Pacemakers 37
Table 52: REPLY 200 DR - Sustainability of Cardiology Services: Economic Evaluation and Communication in Remote Monitoring of People with Pacemakers 38
Table 53: Mathematical Bio-Solutions Inc. Pipeline Products & Ongoing Clinical Trials Overview 39
Table 54: ECN Pacemaker - Product Status 39
Table 55: ECN Pacemaker - Product Description 39
Table 56: Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 40
Table 57: Temporary Epicardial Pacemaker - Product Status 40
Table 58: Temporary Epicardial Pacemaker - Product Description 40
Table 59: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 41
Table 60: Brady Wireless - Product Status 41
Table 61: Brady Wireless - Product Description 42
Table 62: Heart Pacemaker - Product Status 42
Table 63: Heart Pacemaker - Product Description 42
Table 64: Micra Transcatheter Pacing System - Product Status 43
Table 65: Micra Transcatheter Pacing System - Product Description 43
Table 66: Medtronic plc - Ongoing Clinical Trials Overview 44
Table 67: Micra Transcatheter Pacing System - Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA) 45
Table 68: Micra Transcatheter Pacing System - Medtronic Micra Transcatheter Pacing System Continued Access Study 45
Table 69: Micra Transcatheter Pacing System - Micra Transcatheter Pacing Study 45
Table 70: Micra Transcatheter Pacing System - Micra Transcatheter Pacing System Post-Approval Registry 46
Table 71: MicroPort Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 47
Table 72: Implantable Pulse Generator - Product Status 47
Table 73: Implantable Pulse Generator - Product Description 47
Table 74: NDSU Research Foundation Pipeline Products & Ongoing Clinical Trials Overview 48
Table 75: Multi-Electrode Cardiac Pacing System - Product Status 48
Table 76: Multi-Electrode Cardiac Pacing System - Product Description 48
Table 77: NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 49
Table 78: Biological Pacemaker - Product Status 49
Table 79: Biological Pacemaker - Product Description 49
Table 80: Perpetuum Ltd. Pipeline Products & Ongoing Clinical Trials Overview 50
Table 81: Implantable Self-Energising Pacemaker - Product Status 50
Table 82: Implantable Self-Energising Pacemaker - Product Description 50
Table 83: St. Jude Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 51
Table 84: Accent MRI Pacemaker - Product Status 51
Table 85: Accent MRI Pacemaker - Product Description 52
Table 86: Accent ST - Product Status 52
Table 87: Accent ST - Product Description 53
Table 88: Nanostim Leadless Pacemaker - Product Status 53
Table 89: Nanostim Leadless Pacemaker - Product Description 53
Table 90: St. Jude Medical, Inc. - Ongoing Clinical Trials Overview 54
Table 91: Nanostim Leadless Pacemaker - Nanostim Study for a Leadless Cardiac Pacemaker System 55
Table 92: Accent MRI Pacemaker - A Clinical Evaluation of the SJM MRI Conditional Pacing System in Subjects Undergoing Cardiac Magnetic Resonance Imaging in India 56
Table 93: Accent MRI Pacemaker - Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging Lead Investigational Device Exemption Study 56
Table 94: Accent MRI Pacemaker - Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II 56
Table 95: University of Bern Pipeline Products & Ongoing Clinical Trials Overview 57
Table 96: Batteryless Cardiac Pacemaker - Product Status 57
Table 97: Batteryless Cardiac Pacemaker - Product Description 57
Table 98: University of California, Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 58
Table 99: MR3 Next-Generation Pacemaker - Product Status 58
Table 100: MR3 Next-Generation Pacemaker - Product Description 58
Table 101: University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 59
Table 102: Cardiac Energy Harvesting Pacemaker - Product Status 59
Table 103: Cardiac Energy Harvesting Pacemaker - Product Description 59
Table 104: Glossary 123

1.2 List of Figures
Figure 1: Cardiac Pacemakers - Pipeline Products by Stage of Development 9
Figure 2: Cardiac Pacemakers - Pipeline Products by Segment 10
Figure 3: Cardiac Pacemakers - Pipeline Products by Territory 11
Figure 4: Cardiac Pacemakers - Pipeline Products by Regulatory Path 12
Figure 5: Cardiac Pacemakers - Pipeline Products by Estimated Approval Date 13
Figure 6: Cardiac Pacemakers - Ongoing Clinical Trials 14

【掲載企業】

Boston Scientific Corporation
Boston TransTec, LLC
Duke University
EBR Systems, Inc.
Hadasit Medical Research Services & Development Ltd
InnerPulse, Inc.
Kenergy Inc.
Krisara Engineering, LLC
LivaNova PLC
Mathematical Bio-Solutions Inc.
Mayo Clinic US
Medtronic plc
MicroPort Scientific Corporation
NDSU Research Foundation
NuVascular Technologies Inc
Perpetuum Ltd.
St. Jude Medical, Inc.
University of Bern
University of California, Los Angeles
University of Michigan

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