カテゴリ： GlobalData, アメリカ, 企業調査

HeartWare International Inc：企業の製品パイプライン分析2018

◆英語タイトル：HeartWare International Inc - Product Pipeline Analysis, 2018 Update
◆商品コード：DATA904C3008
◆発行会社（調査会社）：GlobalData
◆発行日：2018年8月
◆ページ数：42
◆レポート言語：英語
◆レポート形式：PDF
◆納品方法：Eメール
◆対象地域：アメリカ
◆産業分野：医療機器
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【レポートの概要】

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

【レポートの目次】

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 $68.7 Million In Second Quarter 2016 Revenue 36
Appendix 38
Methodology 38
About GlobalData 41
Contact Us 41
Disclaimer 41

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

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

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