FRAMINGHAM, Mass. and SYDNEY, Dec. 28, 2010 /PRNewswire/ —
HeartWare International, Inc. (Nasdaq:
HTWR; ASX: HIN) today announced that it has submitted a
Pre-Market Approval (PMA) application to the U.S. Food and Drug
Administration (FDA) for the HeartWare® Ventricular Assist
System as a bridge to heart transplantation for patients with
end-stage heart failure.
The PMA submission includes data from HeartWare’s pivotal
ADVANCE clinical trial, 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 ADVANCE, 140 patients at 30 hospitals in the U.S.
received the HeartWare investigational device between August 2008
and February 2010. The final implant in ADVANCE was performed
in February 2010, and the last follow-up evaluation at 180-days was
in August 2010.
Previously announced results for ADVANCE showed that 92% of the
investigational device patients met the per protocol primary
endpoint of the trial, which was defined as alive on the originally
implanted device, transplanted or explanted for recovery at 180
days. Additionally, ADVANCE demonstrated that 94% of the
investigational device patients enrolled in the study achieved a
survival endpoint at 180 days.
Results for the comparator arm of the study, derived from 499
contemporaneous patients from the Interagency Registry for
Mechanically Assisted Circulatory Support (INTERMACS) demonstrated
90% success of the primary endpoint at 180 days. Based on
these results for the primary endpoint of the ADVANCE study,
noninferiority of the investigational device was established
About HeartWare InternationalHeartWare International develops
and manufactures miniaturized implantable heart pumps, or
ventricular assist devices, to treat Class IIIB / IV p