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HeartWare Achieves Primary Endpoint with 92% Success in Pivotal Bridge-to-Transplant Clinical Trial, ADVANCE
Date:11/14/2010

FRAMINGHAM, Mass. and SYDNEY, Nov. 14, 2010 /PRNewswire-FirstCall/ -- HeartWare International, Inc. (Nasdaq: HTWR) (ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that data from its pivotal bridge to heart transplantation (BTT) study, ADVANCE, showed that 92% of the investigational device patients met the per protocol primary endpoint of the trial, which was defined as alive on the originally implanted device, transplanted or explanted for recovery at 180 days.

(Photo: http://photos.prnewswire.com/prnh/20101114/LA01075 )

(Photo: http://www.newscom.com/cgi-bin/prnh/20101114/LA01075 )

Results from the ADVANCE clinical study also demonstrated that 94% of the investigational device patients enrolled in the study achieved a survival endpoint at 180 days, and the study also projected one-year survival of 91% using Kaplan-Meier analysis.

HeartWare's ADVANCE clinical trial is a Food and Drug Administration approved IDE study designed to evaluate the HeartWare® Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.  Between August 2008 and February 2010, 140 patients at 30 hospitals in the United States received the HeartWare investigational device.  The per protocol analysis includes 137 patients in the investigational device cohort.

Results for the comparator arm of the study, derived from 499 contemporaneous patients from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) demonstrated 90% success of the primary endpoint at 180 days, as well as Kaplan-Meier survival at 180 days of 90%, and 86% at 360
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SOURCE HeartWare International, Inc.
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Related medicine technology :

1. Presentation of HeartWare Clinical Results
2. HeartWare International Clinical Trial Shows 90% Survival at 180 Days
3. U.S. FDA Authorizes Expansion to 40 Clinical Sites for HeartWare U.S. Bridge-to-Transplant Clinical Trial
4. HeartWare International Reports Third Quarter Revenues of $7.5 Million
5. HeartWare to Present at 21st Annual Piper Jaffray Health Care Conference in New York City
6. HeartWare to Present at the UBS 2010 Global Life Sciences Conference
7. HeartWare to Present at Lazard Capital Markets Circulatory Assist Device Day
8. HeartWare to Report Financial Results for Third Quarter of 2010
9. HeartWare International Reports Third Quarter 2010 Revenues of $13.8 Million; Compared to $7.5 Million in Third Quarter of 2009
10. HeartWare Bridge-to-Transplant Data Featured as Late Breaking Clinical Trial at American Heart Association Scientific Sessions 2010
11. HeartWare to Present at the Lazard Capital Markets 7th Annual Healthcare Conference
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