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

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


HeartWare International, Inc. Company Snapshot HeartWare International, Inc. Company Overview
HeartWare International, Inc. Pipeline Products and Clinical Trials Overview
HeartWare International, Inc. – Pipeline Analysis Overview
Business Description
Key Facts
HeartWare International, Inc. - Major Products and Services
HeartWare International, Inc. Pipeline Products by Development Stage
HeartWare International, Inc. Clinical Trials by Trial Status
HeartWare International, Inc. Pipeline Products Overview
BiVAD
BiVAD Product Overview
CircuLite SYNERGY Surgical System
CircuLite SYNERGY Surgical System Product Overview
CircuLite SYNERGY Surgical System Clinical Trial
Fully Implantable VAD System
Fully Implantable VAD System Product Overview
Gimbaled Sewing Ring
Gimbaled Sewing Ring Product Overview
HeartWare IV-VAD
HeartWare IV-VAD Product Overview
HeartWare IV-VAD Clinical Trial
HeartWare Ventricular Assist Device - Bridge-To-Transplant
HeartWare Ventricular Assist Device - Bridge-To-Transplant Product Overview
HeartWare Ventricular Assist Device - Bridge-To-Transplant Clinical Trial
HeartWare Ventricular Assist Device - Destination Therapy
HeartWare Ventricular Assist Device - Destination Therapy Product Overview
HeartWare Ventricular Assist Device - Destination Therapy Clinical Trial
Levacor Rotary VAD
Levacor Rotary VAD Product Overview
Longhorn
Longhorn Product Overview
MiFlow VAD
MiFlow VAD Product Overview
Miniaturized Ventricular Assist Device (MVAD) Pump
Miniaturized Ventricular Assist Device (MVAD) Pump Product Overview
Miniaturized Ventricular Assist Device (MVAD) Pump Clinical Trial
MVAD Enhanced Impeller
MVAD Enhanced Impeller Product Overview
MVAD qPulse
MVAD qPulse Product Overview
PAL
PAL Product Overview
Synergy Pocket Micro-Pump - Pediatric System
Synergy Pocket Micro-Pump - Pediatric System Product Overview
VCAN Trans-Mitral
VCAN Trans-Mitral Product Overview
HeartWare International, Inc. - Key Competitors
HeartWare International, Inc. - Key Employees
HeartWare International, Inc. - Key Employee Biographies
HeartWare International, Inc. - Locations And Subsidiaries
Head Office
Other Locations & Subsidiaries
Recent Developments
HeartWare International, Inc., Recent Developments
Mar 14, 2016: HeartWare Appoints Chadwick M. Cornell To Board Of Directors
Jan 11, 2016: HeartWare International Provides Corporate Updates And Announces Preliminary Revenue For Fourth Quarter 2015
Jan 11, 2016: HeartWare Expands Board Of Directors With Appointment Of Stephen N. Oesterle, M.D.
Dec 30, 2015: HeartWare International Confirms Receipt Of Director Nominations Notice
Oct 29, 2015: HeartWare International Reports Third Quarter 2015 Results
Oct 13, 2015: HeartWare Provides Update On MVAD Ventricular Assist System CE Mark Clinical Trial
Sep 09, 2015: HeartWare Provides Operation Updates At 2015 Wells Fargo Healthcare Conference
Aug 10, 2015: HeartWare Completes Enrollment In ENDURANCE2 Supplemental Destination Therapy Trial
Jul 30, 2015: HeartWare Reports $73.6 Million In Second Quarter 2015 Revenue, Driven By Strong Global Unit Growth
Jul 20, 2015: HeartWare Announces First Human Implants Of The MVAD System In CE Mark International Clinical Trial
Appendix Methodology
About GlobalData
Contact Us
Disclaimer
List of Tables
HeartWare International, Inc. Pipeline Products and Clinical Trials Overview
HeartWare International, Inc. Pipeline Products by Equipment Type
HeartWare International, Inc. Pipeline Products by Indication
HeartWare International, Inc. Clinical Trials by Trial Status
HeartWare International, Inc., Key Facts
HeartWare International, Inc., Major Products and Services
HeartWare International, Inc. Number of Pipeline Products by Development Stage
HeartWare International, Inc. Pipeline Products Summary by Development Stage
HeartWare International, Inc. Clinical Trials by Trial Status
HeartWare International, Inc. Clinical Trials Summary
BiVAD - Product Status
BiVAD - Product Description
CircuLite SYNERGY Surgical System - Product Status
CircuLite SYNERGY Surgical System - Product Description
CircuLite SYNERGY Surgical System - Safety and Performance Evaluation of the CircuLite Synergy Pocket Circulatory Assist Device
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)
Fully Implantable VAD System - Product Status
Fully Implantable VAD System - Product Description
Gimbaled Sewing Ring - Product Status
Gimbaled Sewing Ring - Product Description
HeartWare IV-VAD - Product Status
HeartWare IV-VAD - Product Description
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
HeartWare Ventricular Assist Device - Bridge-To-Transplant - Product Status
HeartWare Ventricular Assist Device - Bridge-To-Transplant - Product Description
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
HeartWare Ventricular Assist Device - Bridge-To-Transplant - Evaluation of and Safety and efficacy of HeartWare Ventricular Assist Device - Bridge-to-Transplant in Japan
HeartWare Ventricular Assist Device - Destination Therapy - Product Status
HeartWare Ventricular Assist Device - Destination Therapy - Product Description
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
Levacor Rotary VAD - Product Status
Levacor Rotary VAD - Product Description
Longhorn - Product Status
Longhorn - Product Description
MiFlow VAD - Product Status
MiFlow VAD - Product Description
Miniaturized Ventricular Assist Device (MVAD) Pump - Product Status
Miniaturized Ventricular Assist Device (MVAD) Pump - Product Description
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
MVAD Enhanced Impeller - Product Status
MVAD Enhanced Impeller - Product Description
MVAD qPulse - Product Status
MVAD qPulse - Product Description
PAL - Product Status
PAL - Product Description
Synergy Pocket Micro-Pump - Pediatric System - Product Status
Synergy Pocket Micro-Pump - Pediatric System - Product Description
VCAN Trans-Mitral - Product Status
VCAN Trans-Mitral - Product Description
HeartWare International, Inc., Key Employees
HeartWare International, Inc., Key Employee Biographies
HeartWare International, Inc., Other Locations
HeartWare International, Inc., Subsidiaries
List of Figures
HeartWare International, Inc. Pipeline Products by Equipment Type
HeartWare International, Inc. Pipeline Products by Development Stage
HeartWare International, Inc. Clinical Trials by Trial Status

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