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HeartWare Gets Second Patient Allotment Under Continued Access Protocol For Pivotal U.S. Bridge-To-Transplant Clinical Trial - Quick Facts

(RTTNews) - HeartWare International, Inc. (HTWR) said Friday that the U.S. Food and Drug Administration has approved an Investigational Device Exemption Supplement that allows HeartWare to enroll a second allotment of 54 patients in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol.

The FDA granted an initial allotment of 54 patients in April and the final patient was implanted under the initial allotment last 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. The primary endpoint of the trial is survival at 180-days, defined as alive on the originally implanted device or transplanted or explanted for recovery.

Results of the ADVANCE trial are scheduled to be announced as part of a Late-Breaking Clinical Trial session at American Heart Association's upcoming Scientific Sessions 2010 to be held in Chicago, November 13-17.

HeartWare said it currently expects to submit an PMA application to the FDA seeking approval of the HeartWare System for the bridge-to-transplant indication in December.

Additionally, HeartWare said that the FDA has granted the company full approval for enrollment in its IDE destination therapy clinical trial for the HeartWare Ventricular Assist System.

In June, the FDA granted HeartWare conditional approval to begin enrollment in the destination therapy study.