HeartWare's ADVANCE bridge-to-transplant clinical trial: FDA approves additional enrollment under CAP

Apr 8 2010

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 that the U.S. Food and Drug Administration (FDA) has approved an IDE (Investigational Device Exemption) Supplement that allows HeartWare to enroll up to an additional 54 patients in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).

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.  

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.  The final implant in ADVANCE was conducted on February 25, 2010, which will result in the final patient reaching the 180-day follow up point by the end of August 2010.  

Patient enrollment under the CAP can now commence at the 30 centers participating in the ADVANCE clinical trial, subject to Institutional Review Board approvals at the centers.  The CAP patients will be enrolled and followed under a modified protocol of the ADVANCE trial.  HeartWare anticipates submission to the FDA of the PMA seeking approval of the HeartWare System for the bridge-to-transplant indication in December of this year.