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HeartWare Reports Additional Data from Bridge-to-Transplant Clinical Trial and Continued Access Patients
Date:4/15/2011

perience from ADVANCE, the largest BTT study conducted to date, the CAP data has added to our understanding of implantation techniques and post-operative care that appear to impact patient outcomes," explained Doug Godshall, President and Chief Executive Officer of HeartWare.  "We are grateful for the strong leadership of our international customers and U.S. clinical investigators, who share our view about the potential role this new generation of mechanical circulatory assist device can play as a treatment for end-stage heart failure patients."

As announced in November 2010, the ADVANCE study achieved its primary endpoint of establishing noninferiority between the investigational device and comparator arm of the study, which was derived from contemporaneous patients from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) [p<0.0001].  Between August 2008 and February 2010, 140 patients at 30 hospitals in the United States received the HeartWare investigational device.  The final implant in ADVANCE was performed in February 2010, and the last follow-up evaluation at 180-days was in August 2010.  Through the CAP allotments granted by the FDA, an additional 125 patients have been implanted in the ADVANCE clinical study.  HeartWare completed submission to the FDA of a premarket approval (PMA) application  seeking approval of the HeartWare System for the bridge-to-transplant indication on December 28, 2011.

HeartWare® Ventricular Assist System

The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices.  The HVAD pump weighs approximately 5 ounces and displaces a volume of approximately 50 milliliters.

In 2009, HeartWare received CE Marking for the HeartWare S
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SOURCE HeartWare International, Inc.
Copyright©2010 PR Newswire.
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3. HeartWare to Present at the Barclays Capital 2011 Global Healthcare Conference
4. HeartWare International Reports Fourth Quarter 2010 Revenues of $20.9 Million; 71% Increase From $12.2 Million In Fourth Quarter 2009
5. HeartWare Receives Third Patient Allotment From FDA - Authorizing 94 Additional Patients - Under Continued Access Protocol for Pivotal U.S. Bridge-to-Transplant Clinical Trial
6. HeartWare to Present at the 29th Annual J.P. Morgan Healthcare Conference
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