Published on October 6, 2009 at 7:36 AM
HeartWare International, Inc. (Nasdaq: HTWR, ASX: HIN) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to expand the number of clinical sites participating in its U.S. bridge-to-transplant trial, known as the ADVANCE trial. Pursuant to the FDA approval, HeartWare will be permitted to enroll a total of 40 clinical sites for the purposes of evaluating the Company's Ventricular Assist System (HVAD) in end-stage heart failure patients requiring circulatory support to bridge them to a heart transplant.
"We continue to be encouraged by the number of physicians who believe the HVAD may provide an important benefit for their patients and we hope that the enthusiasm for our system continues to grow as their experience expands," said Doug Godshall, President and CEO of HeartWare.
"While we have had strong interest from high caliber transplant centers that want to join our ADVANCE trial, we could not previously accommodate them due to our existing 28 clinical site limitation. Receipt of FDA approval enabling expansion from 28 to 40 clinical sites allows us to accept many of these additional sites prior to the completion of enrolment which we project will occur in the first half of 2010," continued Godshall.
SOURCE HeartWare International, Inc.