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HeartWare Receives Third Patient Allotment From FDA - Authorizing 94 Additional Patients - Under Continued Access Protocol for Pivotal U.S. Bridge-to-Transplant Clinical Trial
Date:1/24/2011

FRAMINGHAM, Mass. and SYDNEY, Jan. 24, 2011 /PRNewswire/ -- 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 the U.S. Food and Drug Administration (FDA) has approved an IDE (Investigational Device Exemption) Supplement that allows HeartWare to enroll a third allotment, of 94 additional patients, in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).  The FDA granted two prior allotments of 54 patients each in April and September 2010, and the final patient from the second cohort was implanted earlier this month.

HeartWare's ADVANCE clinical trial is an FDA approved IDE study designed to evaluate the HeartWare® Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.  Under the ADVANCE study, 140 patients at 30 U.S. clinical sites received HeartWare HVAD® pumps, making it the largest bridge-to-transplant pivotal trial to date.  HeartWare submitted to the FDA a Pre-Market Approval (PMA) application seeking approval of the HeartWare System for the bridge-to-transplant indication in December 2010.

Patient enrollment under the third CAP can now commence at the 30 centers participating in the ADVANCE clinical trial, subject to Institutional Review Board approvals at these sites.  

About HeartWare InternationalHeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure.  The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implante
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SOURCE HeartWare International, Inc.
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2. HeartWare Files PMA Application for FDA Approval of the HeartWare® Ventricular Assist System for a Bridge-to-Transplant Indication
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10. HeartWare International Reports Third Quarter 2010 Revenues of $13.8 Million; Compared to $7.5 Million in Third Quarter of 2009
11. HeartWare to Report Financial Results for Third Quarter of 2010
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