Implantable Cardioverter Defibrillators (ICD) Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022

Pages: 94 Published: March 17, 2022 Report Code: GDME1314EPD

An implantable cardioverter defibrillator (ICD) is an electronic device that monitors the heart’s rhythm and delivers electric pulses if it detects an arrhythmia to restore the heart’s natural rhythm. ICDs contain three main components: a pulse generator, electrodes, and leads.

The implantable cardioverter defibrillator (ICD) pipeline market research report provides comprehensive information about the ICD pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

What is the territory outlook of the ICD pipeline products market?

The US, Europe, China, Israel, Japan, South Korea, Taiwan, India, Mexico, New Zealand, Singapore, Costa Rica, El Salvador, Australia, and Canada have products in the ICD pipeline. As of March 2022, the US has the highest number of products in the pipeline out of them all.

ICD pipeline products market, by territory

ICD pipeline products market, by territory

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What are the key segments in the ICD pipeline products market?

The segments in the ICD pipeline products are single-chamber implantable cardioverter defibrillators (ICD) and subcutaneous implantable cardioverter defibrillators (ICD). Single-chamber implantable cardioverter defibrillators (ICD) dominates the market.

ICD pipeline products market, by segment

ICD pipeline products market, by segment

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What are the key regulatory paths for the ICD pipeline products market?

The regulatory path followed by the ICD pipeline products are PMA, CE, NMPA, Shonin, BOPA, NIFDS, TGA, HAS, ICAC, and MDL. Majority of products follow the PMA pathway to enter the market.

ICD pipeline products market, by regulatory path

ICD pipeline products market, by regulatory path

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Which are the key companies in the ICD pipeline products market?

Some of the key companies in the ICD market are Arrhythmia Dynamics LLC, Boston Scientific Corp, CardiaLen, Inc., Advanced BioInformatics GmbH, AIS Inc., Coridea, LLC, InnerPulse Inc (Inactive), Johns Hopkins University, Kenergy Inc., Massachusetts General Hospital, Max Planck Institute for Dynamics and Self-Organization, Medicool Technologies Inc, and Medtronic Inc.

Arrhythmia Dynamics LLC

Arrhythmia Dynamics LLC (Arrhythmia Dynamics) focuses on a smart defibrillator algorithm for the treatment of cardiac arrhythmias. Arrhythmia Dynamics is headquartered in Madison, Connecticut, the US.

Boston Scientific Corp

Boston Scientific Corp (Boston Scientific) is a medical technology company that develops, manufactures, and commercializes devices for a range of interventional medical specialties. The company offers products in the areas of electrophysiology, gastroenterology, gastrointestinal surgery, female pelvic medicine, gynecology, interventional cardiology, interventional radiology, neurological surgery, orthopedic surgery, pain medicine, pulmonology, urology, and vascular surgery. Boston Scientific is headquartered in Marlborough, Massachusetts, the US.

CardiaLen, Inc.

CardiaLen Inc provides unpinning termination (UPT) therapy to deliver a sequence of low-energy pulses timed to stop abnormal heart rhythms for atrial fibrillation. It develops a low-energy implantable defibrillator designed to gently restore normal heart rhythm. The company is headquartered in Minneapolis, Minnesota, the US.

Market report scope

Key territories The US, Europe, China, Israel, Japan, South Korea, Taiwan, India, Mexico, New Zealand, Singapore, Costa Rica, El Salvador, Australia, and Canada
Key segments Single-Chamber Implantable Cardioverter Defibrillators (ICD) and Subcutaneous Implantable Cardioverter Defibrillators (ICD)
Key regulatory paths PMA, CE, NMPA, Shonin, BOPA, NIFDS, TGA, HAS, ICAC, and MDL
Key companies Arrhythmia Dynamics LLC, Boston Scientific Corp, CardiaLen, Inc., Advanced BioInformatics GmbH, AIS Inc., Coridea, LLC, InnerPulse Inc (Inactive), Johns Hopkins University, Kenergy Inc., Massachusetts General Hospital, Max Planck Institute for Dynamics and Self-Organization, Medicool Technologies Inc, and Medtronic Inc

Market Scope

This report provides:

  • Extensive coverage of the implantable cardioverter defibrillators (ICD) under development.
  • Details of major pipeline products which includes product description, licensing and collaboration details, and other developmental activities.
  • Major players involved in the development of implantable cardioverter defibrillators (ICD) 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.
  • Key clinical trial data of ongoing trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies.
  • Identify emerging players with potentially strong product portfolio and create effective counterstrategies to gain a competitive advantage.
  • Identify and understand important and diverse types of implantable cardioverter defibrillators (ICD) 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.

Key Players

Advanced BioInformatics GmbH

AIS Inc.

Arrhythmia Dynamics LLC

Boston Scientific Corp

CardiaLen, Inc.

Coridea, LLC

InnerPulse Inc (Inactive)

Johns Hopkins University

Kenergy Inc.

Massachusetts General Hospital

Max Planck Institute for Dynamics and Self-Organization

Medicool Technologies Inc

Medtronic Inc

Medtronic Plc

MicroPort CRM SA

MicroPort Scientific Corp

Smartwave Medical Ltd (Inactive)

University of Chicago

Table of Contents

1 Table of Contents

2 Introduction 9

2.1 Implantable Cardioverter Defibrillators (ICD) Overview 9

3 Products under Development 10

3.1 Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Stage of Development 10

3.2 Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Segment 11

3.3 Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Territory 12

3.4 Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Regulatory Path 13

3.5 Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Estimated Approval Date 14

3.6 Implantable Cardioverter Defibrillators (ICD) – Ongoing Clinical Trials 15

4 Implantable Cardioverter Defibrillators (ICD) – Pipeline Products under Development by Companies 16

4.1 Implantable Cardioverter Defibrillators (ICD) Companies – Pipeline Products by Stage of Development 16

4.2 Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Stage of Development 17

5 Implantable Cardioverter Defibrillators (ICD) Companies and Product Overview 18

5.1 Advanced BioInformatics GmbH Company Overview 18

5.1.1 Advanced BioInformatics GmbH Pipeline Products & Ongoing Clinical Trials Overview 18

5.2 AIS Inc. Company Overview 19

5.2.1 AIS Inc. Pipeline Products & Ongoing Clinical Trials Overview 19

5.3 Arrhythmia Dynamics LLC Company Overview 20

5.3.1 Arrhythmia Dynamics LLC Pipeline Products & Ongoing Clinical Trials Overview 20

5.4 Boston Scientific Corp Company Overview 21

5.4.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 21

5.5 CardiaLen, Inc. Company Overview 24

5.5.1 CardiaLen, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24

5.6 Coridea, LLC Company Overview 28

5.6.1 Coridea, LLC Pipeline Products & Ongoing Clinical Trials Overview 28

5.7 InnerPulse Inc (Inactive) Company Overview 29

5.7.1 InnerPulse Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 29

5.8 Johns Hopkins University Company Overview 30

5.8.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 30

5.9 Kenergy Inc. Company Overview 31

5.9.1 Kenergy Inc. Pipeline Products & Ongoing Clinical Trials Overview 31

5.10 Massachusetts General Hospital Company Overview 32

5.10.1 Massachusetts General Hospital Pipeline Products & Ongoing Clinical Trials Overview 32

5.11 Max Planck Institute for Dynamics and Self-Organization Company Overview 34

5.11.1 Max Planck Institute for Dynamics and Self-Organization Pipeline Products & Ongoing Clinical Trials Overview 34

5.12 Medicool Technologies Inc Company Overview 35

5.12.1 Medicool Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 35

5.13 Medtronic Inc Company Overview 36

5.13.1 Medtronic Inc Pipeline Products & Ongoing Clinical Trials Overview 36

5.14 Medtronic Plc Company Overview 37

5.14.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 37

5.15 MicroPort CRM SA Company Overview 41

5.15.1 MicroPort CRM SA Pipeline Products & Ongoing Clinical Trials Overview 41

5.16 MicroPort Scientific Corp Company Overview 48

5.16.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 48

5.17 Smartwave Medical Ltd (Inactive) Company Overview 49

5.17.1 Smartwave Medical Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 49

5.18 University of Chicago Company Overview 50

5.18.1 University of Chicago Pipeline Products & Ongoing Clinical Trials Overview 50

6 Implantable Cardioverter Defibrillators (ICD)- Recent Developments 51

6.1 Feb 08, 2022: JMS Announces Financial Results for the 3rd Quarter of FYE March 2022 51

6.2 Feb 02, 2022: Nihon Kohden Announces Revisions to its Forecast for Financial Results and Dividend 52

6.3 Feb 02, 2022: Nihon Kohden announces FY2021 third quarter consolidated financial results 53

6.4 Jan 31, 2022: Fukuda Denshi Co. Announces Financial Results for the Third Quarter of the Fiscal Year Ending March 2022 54

6.5 Jan 28, 2022: Japan Lifeline Co. Announces Consolidated Financial Results for the Nine months Ended December 31, 2021 55

6.6 Jan 26, 2022: CONMED Announces Fourth Quarter and Full-Year 2021 Financial Results 55

6.7 Jan 24, 2022: Philips announces Q4 and annual results 2021 56

6.8 Jan 19, 2022: Philips supports the American Heart Association’s efforts to raise awareness of cardiovascular implantable electronic device (CIED) infections, promote guideline adherence, and improve patient survival rates 60

6.9 Jan 04, 2022: Medtronic Chairman and CEO Geoff Martha to speak at J.P. Morgan healthcare conference 60

6.10 Nov 26, 2021: About 12 percent of patients who fill an opioid prescription after common cardiac implants develop persistent opioid use 61

6.11 Nov 12, 2021: Shree Pacetronix Announces Unaudited Financial Results For The Quarter And Half Year Ended 30Th September, 2021 62

6.12 Nov 08, 2021: Nihon Kohden Announces a Revision to its Forecast for Financial Results 62

6.13 Nov 08, 2021: Nihon Kohden announces FY2021 second quarter consolidated financial results 62

6.14 Nov 08, 2021: Boston Scientific Announces Upcoming Conference Schedule 64

6.15 Nov 05, 2021: JMS Announces Financial Results for the Second Quarter of Fiscal Year Ending March 31, 2022 64

6.16 Nov 01, 2021: Japan Lifeline Announces FY3/2022 2Q Financial Results 66

6.17 Oct 29, 2021: Fukuda Denshi announces Financial Results for the Second Quarter of the Fiscal Year Ending March 2022 66

6.18 Oct 27, 2021: Boston Scientific Announces Results For Third Quarter 2021 67

6.19 Oct 27, 2021: CONMED Announces Third Quarter Financial Results 71

6.20 Sep 14, 2021: Nihon Kohden announces a revision to its forecast for financial results for the first half of the fiscal year ending March 31, 2022 72

6.21 Sep 09, 2021: Boston Scientific Announces 2021 Investor Day Meeting 72

6.22 Aug 09, 2021: American Medical Association issues new category III CPT code for ZOLL Medical’s TherOx SSO2 therapy 72

6.23 Aug 06, 2021: JMS Announces Financial Results for the First Quarter of Fiscal Year Ending March 31, 2022 73

6.24 Aug 04, 2021: Nihon Kohden Announces a Revision to its Forecast for Financial Results 73

6.25 Aug 04, 2021: Nihon Kohden Announces Consolidated Financial Results for the 1st Quarter of the Fiscal Year Ending March 31, 2022 74

6.26 Aug 04, 2021: Japan Lifeline Announces FY3/2022 1Q Financial Results 75

6.27 Jul 30, 2021: Fukuda Denshi Co. Announces Financial Results for the First Quarter of the Fiscal Year Ending March 2022 76

6.28 Jul 30, 2021: Fukuda Denshi Notice Regarding Business Forecast and Dividend Forecast for the Fiscal Year Ending March 2022 76

6.29 Jul 28, 2021: CONMED Announces financial results for the second quarter ended June 30, 2021 76

6.30 Jul 21, 2021: Increased physical activity after ICD implantation linked to less hospitalization, death 80

6.31 Jul 14, 2021: Nihon Kohden Announces its Consolidated Financial Forecast for the First Quarter of Fiscal 2021 81

6.32 Jun 25, 2021: Japan Lifeline Notice of Resolution of the 41st Annual General Meeting of Shareholders 81

6.33 May 24, 2021: Boston Scientific to Participate in Bernstein’s 37th Annual Strategic Decisions Conference 82

6.34 May 14, 2021: Fukuda Denshi announces Financial Results for the Fiscal Year Ending March 2021 83

6.35 May 13, 2021: Nihon Kohden announces FY2020 consolidated financial results 83

6.36 May 12, 2021: JMS Announces Financial Results for the Fiscal Year Ended March 31, 2021 83

6.37 Apr 28, 2021: Nihon Kohden Announces Change in Directors 84

6.38 Apr 28, 2021: Fukuda Denshi announces full year consolidated earnings forecast for fiscal year ending march 2021 85

6.39 Apr 28, 2021: CONMED Announces First Quarter Financial Results 85

6.40 Apr 20, 2021: Biotronik: Experts Make the Case for Improved Patient Care in Single-Chamber ICD and CRT-D Therapy with Pioneering DX Technology 86

6.41 Apr 15, 2021: Nihon Kohden Announces a Revision to its Forecast for Financial Results 86

6.42 Apr 01, 2021: CONMED to Announce First Quarter 2021 Financial Results on April 28, 2021 87

6.43 Mar 26, 2021: Philips’ Announces Second-Quarter Results 2021 87

6.44 Mar 23, 2021: CONMED Announces Annual Meeting of Stockholders 89

6.45 Mar 22, 2021: Philips convenes the 2021 Annual General Meeting of Shareholders 90

7 Appendix 91

7.1 Methodology 91

7.2 About GlobalData 94

7.3 Contact Us 94

7.4 Disclaimer 94

List of Tables

Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Stage of Development 10

Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Segment 11

Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Territory 12

Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Regulatory Path 13

Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Estimated Approval Date 14

Implantable Cardioverter Defibrillators (ICD) – Ongoing Clinical Trials 15

Implantable Cardioverter Defibrillators (ICD) Companies – Pipeline Products by Stage of Development 16

Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Stage of Development 17

Advanced BioInformatics GmbH Pipeline Products & Ongoing Clinical Trials Overview 18

Cardiac Rhythm Management Device – Product Status 18

Cardiac Rhythm Management Device – Product Description 18

AIS Inc. Pipeline Products & Ongoing Clinical Trials Overview 19

Guardian – Product Status 19

Guardian – Product Description 19

Arrhythmia Dynamics LLC Pipeline Products & Ongoing Clinical Trials Overview 20

IntelliSync ICD Control Algorithm – Product Status 20

IntelliSync ICD Control Algorithm – Product Description 20

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 21

S-ICD System 1.5 – Product Status 21

S-ICD System 1.5 – Product Description 22

S-ICD System 2.0 – Product Status 22

S-ICD System 2.0 – Product Description 22

VITALITY NXT Defibrillator – Product Status 23

VITALITY NXT Defibrillator – Product Description 23

CardiaLen, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24

MultiPulse Therapy Device – Product Status 24

MultiPulse Therapy Device – Product Description 24

CardiaLen, Inc. – Ongoing Clinical Trials Overview 25

MultiPulse Therapy Device – A Clinical Feasibility Study to Evaluate Patient Perception of MPT 26

MultiPulse Therapy Device – A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-energy Therapy in Patients with Atrial Fibrillation (US) 26

MultiPulse Therapy Device – A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-energy Therapy in Patients with Atrial Fibrillation Energy Therapy in Patients with Atrial Fibrillation 26

MultiPulse Therapy Device – Study Evaluating the Safety and Efficacy of MultiPulse Therapy in an Acute Clinical Setting 27

Coridea, LLC Pipeline Products & Ongoing Clinical Trials Overview 28

Table-Top PaDe System – Product Status 28

Table-Top PaDe System – Product Description 28

InnerPulse Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 29

PICD – Product Status 29

PICD – Product Description 29

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 30

Cardiac Sock Electrode And Implantable Defibrillator System – Product Status 30

Cardiac Sock Electrode And Implantable Defibrillator System – Product Description 30

Kenergy Inc. Pipeline Products & Ongoing Clinical Trials Overview 31

Unconditional MRI Compatible Implantable Defibrillator – Product Status 31

Unconditional MRI Compatible Implantable Defibrillator – Product Description 31

Massachusetts General Hospital Pipeline Products & Ongoing Clinical Trials Overview 32

Implantable Cardioverter Defibrillator – Ventricular Arrhythmias – Product Status 32

Implantable Cardioverter Defibrillator – Ventricular Arrhythmias – Product Description 32

Vagal Stimulation ICD Device – Product Status 33

Vagal Stimulation ICD Device – Product Description 33

Max Planck Institute for Dynamics and Self-Organization Pipeline Products & Ongoing Clinical Trials Overview 34

Implantable Defibrillator – Product Status 34

Implantable Defibrillator – Product Description 34

Medicool Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 35

Implantable Defibrillator – Product Status 35

Implantable Defibrillator – Product Description 35

Medtronic Inc Pipeline Products & Ongoing Clinical Trials Overview 36

LUMINA EV-ICD – Product Status 36

LUMINA EV-ICD – Product Description 36

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 37

Aurora EV-ICD Extravascular Defibrillation System – Product Status 37

Aurora EV-ICD Extravascular Defibrillation System – Product Description 38

Chronicle ICD – Product Status 38

Chronicle ICD – Product Description 38

Medtronic Plc – Ongoing Clinical Trials Overview 39

Aurora EV-ICD Extravascular Defibrillation System – Extravascular ICD Pilot Study 40

Aurora EV-ICD Extravascular Defibrillation System – Extravascular ICD Pivotal Study: EV ICD 40

Aurora EV-ICD Extravascular Defibrillation System – Extravascular Implantable Cardiac Defibrillator Continued Access Study 40

MicroPort CRM SA Pipeline Products & Ongoing Clinical Trials Overview 41

Edis – MRI 1.5 ICD – Product Status 41

Edis – MRI 1.5 ICD – Product Description 41

Edis – Non-MRI ICD – Product Status 42

Edis – Non-MRI ICD – Product Description 42

Navigo 4LV PILOT – Product Status 42

Navigo 4LV PILOT – Product Description 43

Platinium ICD – Product Status 43

Platinium ICD – Product Description 43

Subcutaneous ICD – Product Status 44

Subcutaneous ICD – Product Description 44

Ulys – MRI 1.5 ICD – Product Status 44

Ulys – MRI 1.5 ICD – Product Description 45

Ulys – Non-MRI ICD – Product Status 45

Ulys – Non-MRI ICD – Product Description 45

MicroPort CRM SA – Ongoing Clinical Trials Overview 46

Navigo 4LV PILOT – Safety and Electrical Performances Evaluation of Navigo Leads Equipped with IS4 Connector 47

MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 48

Gali MRI ICD – Product Status 48

Gali MRI ICD – Product Description 48

Smartwave Medical Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 49

Fully Automatic Implantable Atrial Defibrillator – Product Status 49

Fully Automatic Implantable Atrial Defibrillator – Product Description 49

University of Chicago Pipeline Products & Ongoing Clinical Trials Overview 50

Implantable Cardioverter Defibrillator – Product Status 50

Implantable Cardioverter Defibrillator – Product Description 50

Glossary 93

List of Figures

Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Stage of Development 10

Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Segment 11

Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Territory 12

Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Regulatory Path 13

Implantable Cardioverter Defibrillators (ICD) – Pipeline Products by Estimated Approval Date 14

Implantable Cardioverter Defibrillators (ICD) – Ongoing Clinical Trials 15

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