Heartware completes patient enrollment for ADVANCE clinical trial

HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies revolutionizing the treatment of advanced heart failure, today announced the conclusion of patient enrollment under its "ADVANCE" clinical trial.  

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.  Secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life.

"We witnessed a growing enthusiasm from investigators during this study, and we are grateful for their continued support," said HeartWare President and CEO Doug Godshall. "We also had an unexpected acceleration to the completion of the enrollment phase of the trial.  During routine discussion with the FDA, we were asked to change the definition of 'enrolled' in our IDE protocol to include patients who were consented to enter the trial, as opposed to those who were consented and met all inclusion and none of the exclusion criteria.  With two additional implants scheduled, this modification will result in 30 U.S. clinical sites implanting a total of 140 patients, making ADVANCE the largest bridge-to-transplant pivotal trial to date."

The final implant in ADVANCE is scheduled to occur on February 25, 2010, which, if it goes forward as planned, would result in the final patient reaching the 180-day follow up by the end of August 2010.  As a result, it is now anticipated that the submission to the FDA of the PMA will occur in early December rather than late December or early January as previously described.  

With completion of the ADVANCE enrollment, HeartWare is seeking approval from the FDA to implant additional bridge-to-transplant patients under a Continued Access Protocol or "CAP" in any U.S. center that implanted a patient under the trial.  While there is no guarantee that a CAP will be granted, the FDA has allowed CAPs following full enrollment in prior VAD trials, as it makes the technology available to patients and clinicians while also providing additional safety data for the FDA to evaluate.