カテゴリ： GlobalData, アメリカ, 企業調査

HeartWare International Inc：製品パイプライン分析

◆英語タイトル：HeartWare International Inc - Product Pipeline Analysis, 2017 Update
◆商品コード：DATA8012869
◆発行会社（調査会社）：GlobalData
◆発行日：2017年11月3日
◆ページ数：47
◆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 5
HeartWare International Inc Company Overview 6
HeartWare International Inc Company Snapshot 6
HeartWare International Inc Pipeline Products and Ongoing Clinical Trials Overview 7
HeartWare International Inc – Pipeline Analysis Overview 9
Business Description 9
HeartWare International Inc – Key Facts 9
HeartWare International Inc – Major Products and Services 10
HeartWare International Inc Pipeline Products by Development Stage 11
HeartWare International Inc Ongoing Clinical Trials by Trial Status 13
HeartWare International Inc Pipeline Products Overview 15
BiVAD 15
BiVAD Product Overview 15
CircuLite SYNERGY Surgical System 16
CircuLite SYNERGY Surgical System Product Overview 16
CircuLite SYNERGY Surgical System Clinical Trial 17
Fully Implantable VAD System 18
Fully Implantable VAD System Product Overview 18
Gimbaled Sewing Ring 19
Gimbaled Sewing Ring Product Overview 19
HeartWare IV-VAD 20
HeartWare IV-VAD Product Overview 20
HeartWare IV-VAD Clinical Trial 21
HeartWare Ventricular Assist Device – Bridge-To-Transplant 22
HeartWare Ventricular Assist Device – Bridge-To-Transplant Product Overview 22
HeartWare Ventricular Assist Device – Bridge-To-Transplant Clinical Trial 23
Levacor Rotary VAD 24
Levacor Rotary VAD Product Overview 24
Longhorn 25
Longhorn Product Overview 25
MiFlow VAD 26
MiFlow VAD Product Overview 26
Miniaturized Ventricular Assist Device (MVAD) Pump 27
Miniaturized Ventricular Assist Device (MVAD) Pump Product Overview 27
MVAD qPulse 28
MVAD qPulse Product Overview 28
PAL 29
PAL Product Overview 29
Synergy Pocket Micro-Pump – Pediatric System 30
Synergy Pocket Micro-Pump – Pediatric System Product Overview 30
VCAN Trans-Mitral 31
VCAN Trans-Mitral Product Overview 31
HeartWare International Inc – Key Competitors 32
HeartWare International Inc – Key Employees 33
HeartWare International Inc – Key Employee Biographies 34
HeartWare International Inc – Locations And Subsidiaries 35
Head Office 35
Other Locations & Subsidiaries 35
Recent Developments 36
HeartWare International Inc, Recent Developments 36
Sep 27, 2017: Medtronic HeartWare HVAD System Approved for Destination Therapy 36
May 04, 2017: Medtronic Mechanical Circulatory Support (formerly HeartWare) Expands Recall for Ventricular Assist Device Controllers and DC Adapter 37
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 37
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 38
Oct 28, 2016: HeartWare Recalls Ventricular Assist Device Controllers 39
Oct 21, 2016: HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues 39
Sep 30, 2016: FDA Classifies Two Field Actions Related to HeartWare HVAD System as Class 1 Recalls 40
Sep 30, 2016: FDA Classifies Two Field Actions Related to HeartWare HVAD System as Class 1 Recalls 40
Sep 01, 2016: Hazard alert: HeartWare Ventricular Assist Device 41
Jul 28, 2016: HeartWare International Reports $68.7 Million In Second Quarter 2016 Revenue 42
Appendix 44
Methodology 44
About GlobalData 46
Contact Us 46
Disclaimer 47

List of Tables
HeartWare International Inc Pipeline Products and Ongoing Clinical Trials Overview 7
HeartWare International Inc Pipeline Products by Equipment Type 7
HeartWare International Inc Pipeline Products by Indication 8
HeartWare International Inc Ongoing Clinical Trials by Trial Status 8
HeartWare International Inc, Key Facts 9
HeartWare International Inc, Major Products and Services 10
HeartWare International Inc Number of Pipeline Products by Development Stage 11
HeartWare International Inc Pipeline Products Summary by Development Stage 12
HeartWare International Inc Ongoing Clinical Trials by Trial Status 13
HeartWare International Inc Ongoing Clinical Trials Summary 14
BiVAD - Product Status 15
BiVAD - Product Description 15
CircuLite SYNERGY Surgical System - Product Status 16
CircuLite SYNERGY Surgical System - Product Description 16
CircuLite SYNERGY Surgical System - Safety and Performance Evaluation of the CircuLite Synergy Pocket Circulatory Assist Device 17
CircuLite SYNERGY Surgical System - The SYNERGY IC System Based On The Surgical SYNERGY Circulatory Support System-Circulatory Support Pump Designed To Treat Ambulatory Chronic Heart Failure Patients (INTERMACS =4) 17
Fully Implantable VAD System - Product Status 18
Fully Implantable VAD System - Product Description 18
Gimbaled Sewing Ring - Product Status 19
Gimbaled Sewing Ring - Product Description 19
HeartWare IV-VAD - Product Status 20
HeartWare IV-VAD - Product Description 20
HeartWare IV-VAD - A Prospective, Randomized, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the HeartAssist 5 VAD System Compared to the Thoratec HeartMate II VAD and HeartWare HVAD for Left Ventricular Support in Patients Awaiting Cardiac Transplantation 21
HeartWare Ventricular Assist Device - Bridge-To-Transplant - Product Status 22
HeartWare Ventricular Assist Device - Bridge-To-Transplant - Product Description 22
HeartWare Ventricular Assist Device - Bridge-To-Transplant - Evaluation of and Safety and efficacy of HeartWare Ventricular Assist Device - Bridge-to-Transplant in Japan 23
Levacor Rotary VAD - Product Status 24
Levacor Rotary VAD - Product Description 24
Longhorn - Product Status 25
Longhorn - Product Description 25
MiFlow VAD - Product Status 26
MiFlow VAD - Product Description 26
Miniaturized Ventricular Assist Device (MVAD) Pump - Product Status 27
Miniaturized Ventricular Assist Device (MVAD) Pump - Product Description 27
MVAD qPulse - Product Status 28
MVAD qPulse - Product Description 28
PAL - Product Status 29
PAL - Product Description 29
Synergy Pocket Micro-Pump - Pediatric System - Product Status 30
Synergy Pocket Micro-Pump - Pediatric System - Product Description 30
VCAN Trans-Mitral - Product Status 31
VCAN Trans-Mitral - Product Description 31
HeartWare International Inc, Key Employees 33
HeartWare International Inc, Key Employee Biographies 34
HeartWare International Inc, Other Locations 35
HeartWare International Inc, Subsidiaries 35
Glossary 45

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