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HeartWare International Inc - Product Pipeline Analysis, 2018 Update

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  • Details
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Details

Summary

HeartWare International Inc (HeartWare), subsidiary of Medtronic Plc, is a medical device company that develops and manufactures ventricular assist devices and implantable heart pumps for the treatment of advanced heart failure. The company provides HeartWare Ventricular Assist System that consists of a ventricular assist device (VAD) or blood pumps, surgical tools and patient accessories. The system provides circulatory support for patients in advanced stage of heart failure. The company offers products for the treatment of Class IIIB and IV patients who suffer from advanced heart failure. The company sells its products through distributors throughout US, Europe and other countries. HeartWare is headquartered in Framingham, Massachusetts, the US.

This report is a source for data, analysis, and actionable intelligence on the company's portfolio of pipeline products. The report provides key information about the company, its major products and brands.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage.

Scope:

- The report reviews detailed company profile with information on business description, key company facts, major products and services, key competitors, key employees, locations and subsidiaries and recent developments

- The report analyzes all pipeline products in development for the company HeartWare International Inc

- The report provides pipeline analysis on all pipeline products of the company (by equipment type, by indication, by development stage, and by trial status)

- The report covers detailed information on each pipeline product with information on pipeline territory, stage of development, device class, regulatory path, indication(s), application(s) and estimated launch date

- The report provides detailed description of products in development, technical specification and functions

- The report also covers ongoing clinical trials (wherever applicable) with information on trial name, trial objective, sponsor, trial design , trial status and phase, estimated start and end date.

Reasons to Buy:

- Develop business strategies by understanding the trends and developments driving the medical devices pipeline and technology landscape

- Design and develop your product development, marketing and sales strategies by understanding the competitor portfolio

- To formulate effective Research & Development strategies

- Develop market-entry and market expansion strategies

- Exploit in-licensing and out-licensing opportunities by identifying products, most likely to ensure a robust return

- Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

- Develop competition strategies by identifying the status and likely launch of the competitors' pipeline products through review of the clinical trials, stage and of development, etc

- Identify, understand and capitalize the next high-value products that your competitor would add in its portfolio

Note: Some sections may be missing if data is unavailable for the company

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Table Of Content

Scope

Table of Contents

Table of Contents 2

List of Tables 4

List of Figures 4

HeartWare International Inc Company Overview 5

HeartWare International Inc Company Snapshot 5

HeartWare International Inc Pipeline Products and Ongoing Clinical Trials Overview 5

HeartWare International Inc-Pipeline Analysis Overview 7

Business Description 7

HeartWare International Inc-Key Facts 7

HeartWare International Inc-Major Products and Services 8

HeartWare International Inc Pipeline Products by Development Stage 9

HeartWare International Inc Ongoing Clinical Trials by Trial Status 11

HeartWare International Inc Pipeline Products Overview 12

BiVAD 12

BiVAD Product Overview 12

CircuLite SYNERGY Surgical System 13

CircuLite SYNERGY Surgical System Product Overview 13

CircuLite SYNERGY Surgical System Clinical Trial 14

Fully Implantable VAD System 15

Fully Implantable VAD System Product Overview 15

Gimbaled Sewing Ring 16

Gimbaled Sewing Ring Product Overview 16

HeartWare IV-VAD 17

HeartWare IV-VAD Product Overview 17

HeartWare Ventricular Assist Device-Bridge-To-Transplant 18

HeartWare Ventricular Assist Device-Bridge-To-Transplant Product Overview 18

HVAD System-Destination Therapy 19

HVAD System-Destination Therapy Product Overview 19

Levacor Rotary VAD 20

Levacor Rotary VAD Product Overview 20

Longhorn 21

Longhorn Product Overview 21

MiFlow VAD 22

MiFlow VAD Product Overview 22

Miniaturized Ventricular Assist Device (MVAD) Pump 23

Miniaturized Ventricular Assist Device (MVAD) Pump Product Overview 23

Miniaturized Ventricular Assist Device (MVAD) Pump Clinical Trial 24

MVAD qPulse 25

MVAD qPulse Product Overview 25

PAL 26

PAL Product Overview 26

Synergy Pocket Micro-Pump-Pediatric System 27

Synergy Pocket Micro-Pump-Pediatric System Product Overview 27

VCAN Trans-Mitral 28

VCAN Trans-Mitral Product Overview 28

HeartWare International Inc-Key Competitors 29

HeartWare International Inc-Locations And Subsidiaries 30

Head Office 30

Other Locations & Subsidiaries 30

Recent Developments 31

HeartWare International Inc, Recent Developments 31

Jun 01, 2018: FDA Classifies HeartWare HVAD Systems Unexpected Power Source Switching as Class I Recall 31

Sep 27, 2017: Medtronic HeartWare HVAD System Approved for Destination Therapy 31

May 04, 2017: Medtronic Mechanical Circulatory Support (formerly HeartWare) Expands Recall for Ventricular Assist Device Controllers and DC Adapter 32

May 04, 2017: Ventricular Assist Device Controllers and DC Adapter by Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.): Class I Recall-Updated Controller, Power Management Software 33

May 04, 2017: Medtronic Recalls HeartWare Splice Kit Intended to Repair the Driveline of its Ventricular Assist Device Because it May Cause Electrical Issues or Pump Stops 34

Oct 28, 2016: HeartWare Recalls Ventricular Assist Device Controllers 34

Oct 21, 2016: HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues 35

Sep 30, 2016: FDA Classifies Two Field Actions Related to HeartWare HVAD System as Class 1 Recalls 36

Sep 01, 2016: Hazard alert: HeartWare Ventricular Assist Device 36

Jul 28, 2016: HeartWare International Reports USD 68.7 Million In Second Quarter 2016 Revenue 36

Appendix 38

Methodology 38

About GlobalData 41

Contact Us 41

Disclaimer 41


List Of Figure

List of Figures

HeartWare International Inc Pipeline Products by Equipment Type 7

HeartWare International Inc Pipeline Products by Development Stage 10

HeartWare International Inc Ongoing Clinical Trials by Trial Status 12


List Of Table

List of Tables

HeartWare International Inc Pipeline Products and Ongoing Clinical Trials Overview 6

HeartWare International Inc Pipeline Products by Equipment Type 7

HeartWare International Inc Pipeline Products by Indication 7

HeartWare International Inc Ongoing Clinical Trials by Trial Status 7

HeartWare International Inc, Key Facts 8

HeartWare International Inc, Major Products and Services 9

HeartWare International Inc Number of Pipeline Products by Development Stage 10

HeartWare International Inc Pipeline Products Summary by Development Stage 11

HeartWare International Inc Ongoing Clinical Trials by Trial Status 12

HeartWare International Inc Ongoing Clinical Trials Summary 12

BiVAD-Product Status 13

BiVAD-Product Description 13

CircuLite SYNERGY Surgical System-Product Status 14

CircuLite SYNERGY Surgical System-Product Description 14

CircuLite SYNERGY Surgical System-Safety and Performance Evaluation of the CircuLite Synergy Pocket Circulatory Assist Device 15

Fully Implantable VAD System-Product Status 16

Fully Implantable VAD System-Product Description 16

Gimbaled Sewing Ring-Product Status 17

Gimbaled Sewing Ring-Product Description 17

HeartWare IV-VAD-Product Status 18

HeartWare IV-VAD-Product Description 18

HeartWare Ventricular Assist Device-Bridge-To-Transplant-Product Status 19

HeartWare Ventricular Assist Device-Bridge-To-Transplant-Product Description 19

HVAD System-Destination Therapy-Product Status 20

HVAD System-Destination Therapy-Product Description 20

Levacor Rotary VAD-Product Status 21

Levacor Rotary VAD-Product Description 21

Longhorn-Product Status 22

Longhorn-Product Description 22

MiFlow VAD-Product Status 23

MiFlow VAD-Product Description 23

Miniaturized Ventricular Assist Device (MVAD) Pump-Product Status 24

Miniaturized Ventricular Assist Device (MVAD) Pump-Product Description 24

Miniaturized Ventricular Assist Device (MVAD) Pump-Multi Center, Prospective, Non-randomized, Single-arm Trial Evaluating the Clinical Safety and Performance of the HeartWare MVAD System for the Treatment of Advanced Heart Failure 25

MVAD qPulse-Product Status 26

MVAD qPulse-Product Description 26

PAL-Product Status 27

PAL-Product Description 27

Synergy Pocket Micro-Pump-Pediatric System-Product Status 28

Synergy Pocket Micro-Pump-Pediatric System-Product Description 28

VCAN Trans-Mitral-Product Status 29

VCAN Trans-Mitral-Product Description 29

HeartWare International Inc, Other Locations 31

HeartWare International Inc, Subsidiaries 31

Glossary 41

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Products and Companies

Products

HeartWare International Inc, Product, Pipeline, Product Pipeline, Key Pipeline, Products by Equipment Type, Equipment Type, Therapy Area, Products by Therapy Area, Development Stage, Products by Development Stage, Milestone, Products by Milestone, Major Products, Brands, No of Products, Device Class, Market, Territory, Product Name, Therapy Name, Trial Name, Trial, Indication, Summary, Event Type, Clinical Trial, MileStone, Product Status, Product Description, Description, Patent, Patent Details, Competitors, Key Employees, Subsidiaries, Locations, News, Events, Developments, medical devices, business description, company facts, trial phase, approval, estimated, technology, product patent details, phase, trial status, trial objective, trial design, trial site, business strategies, trends, pipeline and technology, sales strategies


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