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HeartWare International, Inc. (HTWR) - Product Pipeline Analysis, 2016 Update

Published: Mar 22, 2016 | Pages: 51 | Publisher: GlobalData | Industry: Medical Devices | Report Format: Electronic (PDF)

Summary

HeartWare International, Inc. (HeartWare) is a medical device company that develops and manufactures ventricular assist devices and implantable heart pumps for the treatment of advanced heart failure. HeartWare 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. It is also evaluating the next generation miniaturized device, MVAD System developed on the same technology for further reducing surgical invasiveness while producing superior clinical results. The company offers its products for the treatment of Class IIIB and IV patients who suffer from advanced heart failure. HeartWare sells its products through distributors throughout US, Europe and other countries. HeartWare is headquartered in Framingham, 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
 Table of Contents 
Table of Contents 2
List of Tables  4
List of Figures  6
HeartWare International, Inc. Company Snapshot  7
HeartWare International, Inc. Company Overview  7
HeartWare International, Inc. Pipeline Products and Clinical Trials Overview  8
HeartWare International, Inc. - Pipeline Analysis Overview  10
Business Description  10
Key Facts  11
HeartWare International, Inc. - Major Products and Services  12
HeartWare International, Inc. Pipeline Products by Development Stage  13
HeartWare International, Inc. Clinical Trials by Trial Status  15
HeartWare International, Inc. Pipeline Products Overview  17
BiVAD  17
BiVAD Product Overview  17
CircuLite SYNERGY Surgical System  18
CircuLite SYNERGY Surgical System Product Overview  18
CircuLite SYNERGY Surgical System Clinical Trial  19
Fully Implantable VAD System  20
Fully Implantable VAD System Product Overview  20
Gimbaled Sewing Ring  21
Gimbaled Sewing Ring Product Overview  21
HeartWare IV-VAD  22
HeartWare IV-VAD Product Overview  22
HeartWare IV-VAD Clinical Trial  23
HeartWare Ventricular Assist Device - Bridge-To-Transplant  24
HeartWare Ventricular Assist Device - Bridge-To-Transplant Product Overview  24
HeartWare Ventricular Assist Device - Bridge-To-Transplant Clinical Trial  25
HeartWare Ventricular Assist Device - Destination Therapy  26
HeartWare Ventricular Assist Device - Destination Therapy Product Overview  26
HeartWare Ventricular Assist Device - Destination Therapy Clinical Trial  27
Levacor Rotary VAD  28
Levacor Rotary VAD Product Overview  28
Longhorn  29
Longhorn Product Overview  29
MiFlow VAD  30
MiFlow VAD Product Overview  30
Miniaturized Ventricular Assist Device (MVAD) Pump  31
Miniaturized Ventricular Assist Device (MVAD) Pump Product Overview  31
Miniaturized Ventricular Assist Device (MVAD) Pump Clinical Trial  32
MVAD Enhanced Impeller  33
MVAD Enhanced Impeller Product Overview  33
MVAD qPulse  34
MVAD qPulse Product Overview  34
PAL  35
PAL Product Overview  35
Synergy Pocket Micro-Pump - Pediatric System  36
Synergy Pocket Micro-Pump - Pediatric System Product Overview  36
VCAN Trans-Mitral  37
VCAN Trans-Mitral Product Overview  37
HeartWare International, Inc. - Key Competitors  38
HeartWare International, Inc. - Key Employees  39
HeartWare International, Inc. - Key Employee Biographies  40
HeartWare International, Inc. - Locations And Subsidiaries  41
Head Office  41
Other Locations & Subsidiaries  41
Recent Developments  42
HeartWare International, Inc., Recent Developments  42
Mar 14, 2016: HeartWare Appoints Chadwick M. Cornell To Board Of Directors  42
Jan 11, 2016: HeartWare International Provides Corporate Updates And Announces Preliminary Revenue For Fourth Quarter 2015  42
Jan 11, 2016: HeartWare Expands Board Of Directors With Appointment Of Stephen N. Oesterle, M.D.  43
Dec 30, 2015: HeartWare International Confirms Receipt Of Director Nominations Notice  44
Oct 29, 2015: HeartWare International Reports Third Quarter 2015 Results  45
Oct 13, 2015: HeartWare Provides Update On MVAD Ventricular Assist System CE Mark Clinical Trial  46
Sep 09, 2015: HeartWare Provides Operation Updates At 2015 Wells Fargo Healthcare Conference  47
Aug 10, 2015: HeartWare Completes Enrollment In ENDURANCE2 Supplemental Destination Therapy Trial  47
Jul 30, 2015: HeartWare Reports $73.6 Million In Second Quarter 2015 Revenue, Driven By Strong Global Unit Growth  48
Jul 20, 2015: HeartWare Announces First Human Implants Of The MVAD System In CE Mark International Clinical Trial  49
Appendix  51
Methodology  51
About GlobalData  51
Contact Us  51
Disclaimer  51
List of Tables
HeartWare International, Inc. Pipeline Products and Clinical Trials Overview  8
HeartWare International, Inc. Pipeline Products by Equipment Type  8
HeartWare International, Inc. Pipeline Products by Indication  9
HeartWare International, Inc. Clinical Trials by Trial Status  9
HeartWare International, Inc., Key Facts  11
HeartWare International, Inc., Major Products and Services  12
HeartWare International, Inc. Number of Pipeline Products by Development Stage  13
HeartWare International, Inc. Pipeline Products Summary by Development Stage  14
HeartWare International, Inc. Clinical Trials by Trial Status  15
HeartWare International, Inc. Clinical Trials Summary  16
BiVAD - Product Status  17
BiVAD - Product Description  17
CircuLite SYNERGY Surgical System - Product Status  18
CircuLite SYNERGY Surgical System - Product Description  18
CircuLite SYNERGY Surgical System - Safety and Performance Evaluation of the CircuLite Synergy Pocket Circulatory Assist Device  19
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)  19
Fully Implantable VAD System - Product Status  20
Fully Implantable VAD System - Product Description  20
Gimbaled Sewing Ring - Product Status  21
Gimbaled Sewing Ring - Product Description  21
HeartWare IV-VAD - Product Status  22
HeartWare IV-VAD - Product Description  22
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  23
HeartWare Ventricular Assist Device - Bridge-To-Transplant - Product Status  24
HeartWare Ventricular Assist Device - Bridge-To-Transplant - Product Description  24
HeartWare Ventricular Assist Device - Bridge-To-Transplant - A Multi-Center, Post Approval Study Providing Continued Evaluation and Follow-up on Patients Who Received a HeartWare Ventricular Assist System During IDE Trials for the Treatment of Advanced Heart Failure  25
HeartWare Ventricular Assist Device - Bridge-To-Transplant - Evaluation of and Safety and efficacy of HeartWare Ventricular Assist Device - Bridge-to-Transplant in Japan  25
HeartWare Ventricular Assist Device - Destination Therapy - Product Status  26
HeartWare Ventricular Assist Device - Destination Therapy - Product Description  26
HeartWare Ventricular Assist Device - Destination Therapy - A Prospective, Randomized, Controlled, Unblinded, Multi-center Clinical Trial to Evaluate the HeartWare Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure  27
Levacor Rotary VAD - Product Status  28
Levacor Rotary VAD - Product Description  28
Longhorn - Product Status  29
Longhorn - Product Description  29
MiFlow VAD - Product Status  30
MiFlow VAD - Product Description  30
Miniaturized Ventricular Assist Device (MVAD) Pump - Product Status  31
Miniaturized Ventricular Assist Device (MVAD) Pump - Product Description  31
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  32
MVAD Enhanced Impeller - Product Status  33
MVAD Enhanced Impeller - Product Description  33
MVAD qPulse - Product Status  34
MVAD qPulse - Product Description  34
PAL - Product Status  35
PAL - Product Description  35
Synergy Pocket Micro-Pump - Pediatric System - Product Status  36
Synergy Pocket Micro-Pump - Pediatric System - Product Description  36
VCAN Trans-Mitral - Product Status  37
VCAN Trans-Mitral - Product Description  37
HeartWare International, Inc., Key Employees  39
HeartWare International, Inc., Key Employee Biographies  40
HeartWare International, Inc., Other Locations  41
HeartWare International, Inc., Subsidiaries  41 


List of Figures
HeartWare International, Inc. Pipeline Products by Equipment Type  9
HeartWare International, Inc. Pipeline Products by Development Stage  13
HeartWare International, Inc. Clinical Trials by Trial Status  15

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