Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Medical Devices Pipeline Assessment, 2017

Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Medical Devices Pipeline Assessment, 2017


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Executive Summary

Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Medical Devices Pipeline Assessment, 2017

Summary

GlobalData's Medical Devices sector report, "Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Medical Devices Pipeline Assessment, 2017" provides an overview of Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads 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 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads 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 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads 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 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads 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 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads 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



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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 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads Overview 8

3 Products under Development 9

3.1 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products by Stage of Development 9

3.2 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products by Territory 10

3.3 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products by Regulatory Path 11

3.4 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products by Estimated Approval Date 12

3.5 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Ongoing Clinical Trials 13

4 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products under Development by Companies 14

4.1 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads Companies-Pipeline Products by Stage of Development 14

4.2 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products by Stage of Development 15

5 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads Companies and Product Overview 16

5.1 Boston Scientific Corp Company Overview 16

5.1.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 16

5.2 Imricor Medical Systems Inc Company Overview 24

5.2.1 Imricor Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 24

5.3 LivaNova PLC Company Overview 25

5.3.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 25

5.4 Mayo Clinic US Company Overview 30

5.4.1 Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 30

5.5 Medtronic plc Company Overview 32

5.5.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 32

5.6 MicroPort Scientific Corp Company Overview 37

5.6.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 37

5.7 MRI Interventions Inc Company Overview 39

5.7.1 MRI Interventions Inc Pipeline Products & Ongoing Clinical Trials Overview 39

5.8 St. Jude Medical LLC Company Overview 40

5.8.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 40

5.9 Teleflex Inc Company Overview 48

5.9.1 Teleflex Inc Pipeline Products & Ongoing Clinical Trials Overview 48

6 Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads- Recent Developments 49

6.1 Jul 24, 2017: MicroPort Attends EUROPACE-CARDIOSTIM 2017 49

6.2 Jul 17, 2017: Integer Announces Appointment of Joseph W. Dziedzic as President and Chief Executive Officer 49

6.3 Jul 11, 2017: MRI Interventions Announces Record Second Quarter ClearPoint System Procedures, And a 79% Year-Over-Year Revenue Increase 50

6.4 Jul 07, 2017: MPSC New COO Glendy Wang on Board 50

6.5 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 51

6.6 Jun 19, 2017: BioTrace Medical's Tempo Lead Shows Stability and Safety in Real-World Performance Consistent with Clinical Study Outcomes In TVT 2017 Presentation 53

6.7 Jun 14, 2017: Spectranetics Announces Election of New Chairperson of the Board of Directors 54

6.8 Jun 12, 2017: LivaNova Appoints Keyna Skeffington as Senior Vice President and General Counsel 55

6.9 Jun 08, 2017: BioTrace Medical Announces Key Activities at TVT 2017 55

6.10 May 25, 2017: Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results 56

6.11 May 16, 2017: LivaNova Announces Thad Huston as Chief Financial Officer 59

6.12 May 11, 2017: Healthcare Veteran John Fletcher Joins MRI Interventions' Board of Directors 59

6.13 May 09, 2017: Boston Scientific Receives U.S. FDA Approval For Resonate Family Of High-Voltage Devices 60

6.14 May 08, 2017: BIOTRONIK Receives FDA Approval for Sentus ProMRI Quadripolar Left Ventricular Lead 61

6.15 May 08, 2017: Integer Holdings Reports First Quarter 2017 Results 61

6.16 May 03, 2017: LivaNova Reports First Quarter 2017 Results 62

6.17 May 02, 2017: T2 Biosystems Reports First Quarter 2017 Results and Corporate Update 64

6.18 May 01, 2017: T2 Biosystems Names Darlene Deptula-Hicks as Chief Financial Officer 65

6.19 Apr 27, 2017: Boston Scientific Announces Results For First Quarter 2017 66

6.20 Apr 27, 2017: MRI Interventions Announces 2017 First Quarter Results 67

6.21 Apr 27, 2017: Spectranetics Reports First Quarter 2017 Revenue of $69.7 million 69

6.22 Apr 18, 2017: BIOTRONIK Introduces Smallest MR Conditional Defibrillator Lead in the US 69

6.23 Apr 06, 2017: New ICD Lead with Helical Design Now Launched in Europe 70

6.24 Apr 06, 2017: MRI Interventions Announces Record Quarterly Revenue, Record ClearPoint System Procedures in 2017 First Quarter 71

6.25 Mar 31, 2017: LivaNova Announces Chief Financial Officer Resignation 71

6.26 Mar 31, 2017: LivaNova Reiterates Full-Year 2017 Guidance 71

6.27 Mar 30, 2017: MPSC Announces 2016 Annual Results 72

6.28 Mar 27, 2017: Integer Announces Leadership Change 73

6.29 Mar 01, 2017: LivaNova Reports Fourth Quarter and Full-Year 2016 Results 74

6.30 Feb 28, 2017: MRI Interventions Announces 2016 Fourth Quarter and Full Year Results 76

6.31 Feb 27, 2017: Gary Haire to Join Integer as Executive Vice President and Chief Financial Officer 79

6.32 Feb 27, 2017: Integer Holdings Reports Results for Fourth Quarter and Full Year 2016 80

6.33 Feb 23, 2017: Spectranetics Reports Fourth Quarter 2016 Revenue of $71.9 million 83

6.34 Feb 23, 2017: LivaNova Announces Its Intent to Delist from London Stock Exchange 84

6.35 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 84

6.36 Feb 14, 2017: BIOTRONIK Simplifies MR-Conditional Cardiac System Selection with the Launch of the ProMRI Configurator 87

6.37 Feb 13, 2017: T2 Biosystems Reports Fourth Quarter and Full-Year 2016 Results 88

6.38 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 89

6.39 Feb 02, 2017: Boston Scientific Announces Results For Fourth Quarter And Full Year Ended December 31, 2016 90

6.40 Feb 01, 2017: Abbott Announces U.S. Approval for its Tendril MRI pacing lead 91

6.41 Jan 24, 2017: MRI Interventions Announces Year-End Update, Including 2016 Fourth Quarter and Full Year Revenues 92

6.42 Jan 11, 2017: Spectranetics Names Scott Hutton as General Manager, Vascular Intervention 93

6.43 Jan 09, 2017: T2 Biosystems Reports Preliminary Fourth Quarter Results and Operational Progress 93

6.44 Dec 19, 2016: BioTrace Medical Announces First U.S. Patients Treated with Company's Innovative Temporary Pacing Lead 94

6.45 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 95

6.46 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 98

6.47 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 98

6.48 Nov 04, 2016: MRI Interventions Announces 2016 Third Quarter and Nine Month Results 99

6.49 Nov 02, 2016: LivaNova Announces CEO Transition: Damien McDonald to Succeed Andre-Michel Ballester 103

6.50 Nov 02, 2016: LivaNova Reports Third Quarter 2016 Results 104

6.51 Nov 01, 2016: T2 Biosystems Reports Third Quarter Results 105

6.52 Oct 31, 2016: BioTrace Medical Announces Positive Data From Clinical Study of Innovative Temporary Pacing Technology for Transcatheter Aortic Valve Procedures and Other Cardiovascular Applications 107

6.53 Oct 27, 2016: Spectranetics Reports Third Quarter 2016 Revenue of $68.3 million 108

6.54 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 108

6.55 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 110

6.56 Oct 13, 2016: Medtronic Cardiac Devices Gain FDA Approval to Enable Patient Access to the Most Advanced Diagnostic Imaging 112

6.57 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 113

6.58 Sep 29, 2016: LivaNova Announces Half-Year Financial Report 113

6.59 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 122

6.60 Aug 30, 2016: MPSC Announces 2016 Interim Results 123

6.61 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 124

6.62 Aug 15, 2016: MRI Interventions Announces 2016 Second Quarter and Six Month Results 127

6.63 Aug 03, 2016: LivaNova Reports Second Quarter 2016 Results 131

6.64 Aug 01, 2016: LivaNova Names Chief Operating Officer 132

6.65 Aug 01, 2016: T2 Biosystems Reports 2016 Second Quarter, Six-Month Results 133

7 Appendix 136

7.1 Methodology 136

7.2 About GlobalData 139

7.3 Contact Us 139

7.4 Disclaimer 139

1.2 List of Figures

Figure 1: Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products by Stage of Development 9

Figure 2: Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products by Territory 10

Figure 3: Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products by Regulatory Path 11

Figure 4: Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products by Estimated Approval Date 12

Figure 5: Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Ongoing Clinical Trials 13

1.1 List of Tables

Table 1: Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products by Stage of Development 9

Table 2: Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products by Territory 10

Table 3: Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products by Regulatory Path 11

Table 4: Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products by Estimated Approval Date 12

Table 5: Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Ongoing Clinical Trials 13

Table 6: Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads Companies-Pipeline Products by Stage of Development 14

Table 7: Cardiovascular Pacing and Implantable Cardioverter-Defibrillator (ICD) Leads-Pipeline Products by Stage of Development 15

Table 8: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 16

Table 9: INGEVITY MRI Pacing Lead-Product Status 16

Table 10: INGEVITY MRI Pacing Lead-Product Description 17

Table 11: Next Generation ICD Lead-Product Status 17

Table 12: Next Generation ICD Lead-Product Description 17

Table 13: Reliance 4-Front Lead-Product Status 18

Table 14: Reliance 4-Front Lead-Product Description 18

Table 15: X4 SYSTEM + QUAD LEAD-Product Status 18

Table 16: X4 SYSTEM + QUAD LEAD-Product Description 19

Table 17: Boston Scientific Corp-Ongoing Clinical Trials Overview 20

Table 18: INGEVITY MRI Pacing Lead-Expanding MRI Access for Patients with New and Existing ICDs and CRT-Ds: ENABLE MRI 21

Table 19: INGEVITY MRI Pacing Lead-INGEVITY Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study 21

Table 20: Reliance 4-Front Lead-Evaluation of Acuity X4 Quadripolar Coronary Venous Leads and Reliance 4-Front Defibrillation Leads: NAVIGATE X4 22

Table 21: Reliance 4-Front Lead-Expanding MRI Access for Patients with New and Existing ICDs and CRT-Ds: ENABLE MRI 22

Table 22: Reliance 4-Front Lead-RELIANCE 4-FRONT Passive Fixation Defibrillation Lead Post Market Clinical Follow-up (PMCF) Study 23

Table 23: Imricor Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 24

Table 24: Magnetic Resonance Imaging (MRI) Compatible Lead-Product Status 24

Table 25: Magnetic Resonance Imaging (MRI) Compatible Lead-Product Description 24

Table 26: LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 25

Table 27: Beflex Brady Lead-Product Status 25

Table 28: Beflex Brady Lead-Product Description 26

Table 29: Nano Lead System-Product Status 26

Table 30: Nano Lead System-Product Description 26

Table 31: SonR Tist Lead Positioning-Product Status 27

Table 32: SonR Tist Lead Positioning-Product Description 27

Table 33: SonRFix Lead-Product Status 27

Table 34: SonRFix Lead-Product Description 28

Table 35: Tachy Lead-Product Status 28

Table 36: Tachy Lead-Product Description 28

Table 37: TX Brady Lead-Product Status 29

Table 38: TX Brady Lead-Product Description 29

Table 39: Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 30

Table 40: Epicardial Pacing/sensing Lead-Product Status 30

Table 41: Epicardial Pacing/sensing Lead-Product Description 30

Table 42: Pacemaker/ICD Lead-Product Status 31

Table 43: Pacemaker/ICD Lead-Product Description 31

Table 44: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 32

Table 45: Attain 4798 Stability Quad Lead-Product Status 32

Table 46: Attain 4798 Stability Quad Lead-Product Description 32

Table 47: Pacing Lead (Model 4296 LV Lead)-Product Status 33

Table 48: Pacing Lead (Model 4296 LV Lead)-Product Description 33

Table 49: Medtronic plc-Ongoing Clinical Trials Overview 34

Table 50: Pacing Lead (Model 4296 LV Lead)-Attain Ability Family Left Ventricular Lead Chronic Performance Study 35

Table 51: Pacing Lead (Model 4296 LV Lead)-Remodeling the Left Ventricle with Atrial Modulated Pacing 35

Table 52: Attain 4798 Stability Quad Lead-Attain Stability Quad Clinical Study 36

Table 53: MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 37

Table 54: BonaFire-Active Pacing Lead-Product Status 37

Table 55: BonaFire-Active Pacing Lead-Product Description 37

Table 56: BonaFire-Passive Pacing Lead-Product Status 38

Table 57: BonaFire-Passive Pacing Lead-Product Description 38

Table 58: MRI Interventions Inc Pipeline Products & Ongoing Clinical Trials Overview 39

Table 59: MRI-Safe Implantable Cardiac Rhythm Management Lead-Product Status 39

Table 60: MRI-Safe Implantable Cardiac Rhythm Management Lead-Product Description 39

Table 61: St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 40

Table 62: Quartet Left Ventricular Pacing Lead-Product Status 40

Table 63: Quartet Left Ventricular Pacing Lead-Product Description 41

Table 64: Quartet NXT-Double Blend Lead-Product Status 41

Table 65: Quartet NXT-Double Blend Lead-Product Description 41

Table 66: Quartet NXT-Large S-Curve Lead-Product Status 42

Table 67: Quartet NXT-Large S-Curve Lead-Product Description 42

Table 68: Quartet NXT-Small S-Curve Lead-Product Status 42

Table 69: Quartet NXT-Small S-Curve Lead-Product Description 43

Table 70: Quartet Quadripolar LV Lead-MRI Labelling-Product Status 43

Table 71: Quartet Quadripolar LV Lead-MRI Labelling-Product Description 43

Table 72: St. Jude Medical LLC-Ongoing Clinical Trials Overview 44

Table 73: Quartet Left Ventricular Pacing Lead-A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an Investigational Device Exemption (IDE) Study 45

Table 74: Quartet Left Ventricular Pacing Lead-Left Ventricular Lead Implant and Optimization Guided by Electrocardiography in Cardiac Resynchronization Therapy-ElectroCRT 45

Table 75: Quartet Left Ventricular Pacing Lead-Optim Lead Insulation Material Registry 45

Table 76: Quartet Left Ventricular Pacing Lead-Post-market Study of Multi-vector LV Lead Performance in Chinese Patients with Chronic Heart Failure 46

Table 77: Quartet Left Ventricular Pacing Lead-Quadripolar Pacing Post Approval Study 46

Table 78: Quartet Left Ventricular Pacing Lead-Quartet Bad Oeynhausen Trial 46

Table 79: Quartet Left Ventricular Pacing Lead-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 47

Table 80: Teleflex Inc Pipeline Products & Ongoing Clinical Trials Overview 48

Table 81: Pacemaker Lead-Product Status 48

Table 82: Pacemaker Lead-Product Description 48

Table 83: Glossary 138

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Boston Scientific Corp

Imricor Medical Systems Inc

LivaNova PLC

Mayo Clinic US

Medtronic plc

MicroPort Scientific Corp

MRI Interventions Inc

St. Jude Medical LLC

Teleflex Inc

Boston Scientific Corp, INGEVITY MRI Pacing Lead; Boston Scientific Corp, Next Generation ICD Lead; Boston Scientific Corp, Reliance 4-Front Lead; Boston Scientific Corp, X4 SYSTEM + QUAD LEAD; Imricor Medical Systems Inc, Magnetic Resonance Imaging (MRI) Compatible Lead; LivaNova PLC , Beflex Brady Lead; LivaNova PLC , Nano Lead System; LivaNova PLC , SonR Tist Lead Positioning; LivaNova PLC , SonRFix Lead; LivaNova PLC , Tachy Lead; LivaNova PLC , TX Brady Lead; Mayo Clinic US, Epicardial Pacing/sensing Lead; Mayo Clinic US, Pacemaker/ICD Lead; Medtronic plc, Attain 4798 Stability Quad Lead; Medtronic plc, Pacing Lead (Model 4296 LV Lead); MicroPort Scientific Corp, BonaFire-Active Pacing Lead; MicroPort Scientific Corp, BonaFire-Passive Pacing Lead; MRI Interventions Inc, MRI-Safe Implantable Cardiac Rhythm Management Lead; St. Jude Medical LLC, Quartet Left Ventricular Pacing Lead; St. Jude Medical LLC, Quartet NXT-Double Blend Lead; St. Jude Medical LLC, Quartet NXT-Large S-Curve Lead; St. Jude Medical LLC, Quartet NXT-Small S-Curve Lead; St. Jude Medical LLC, Quartet Quadripolar LV Lead-MRI Labelling; Teleflex Inc, Pacemaker Lead

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