FRAMINGHAM, Mass. and SYDNEY, Nov. 14, 2010
/PRNewswire-FirstCall/ — HeartWare International, Inc. (Nasdaq:
HTWR) (ASX: HIN), a leading innovator of less invasive,
miniaturized circulatory support technologies that are
revolutionizing the treatment of advanced heart failure, today
announced that data from its pivotal bridge to heart
transplantation (BTT) study, 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.
(Photo: http://photos.prnewswire.com/prnh/20101114/LA01075
)
(Photo: http://www.newscom.com/cgi-bin/prnh/20101114/LA01075
)
Results from the ADVANCE clinical study also demonstrated that
94% of the investigational device patients enrolled in the study
achieved a survival endpoint at 180 days, and the study also
projected one-year survival of 91% using Kaplan-Meier analysis.
HeartWare’s ADVANCE clinical trial is a Food and Drug
Administration approved IDE study designed to evaluate the
HeartWare® Ventricular Assist System as a bridge to heart
transplantation for patients with end-stage heart failure.
Between August 2008 and February 2010, 140 patients at 30
hospitals in the United States received the HeartWare
investigational device. The per protocol analysis includes
137 patients in the investigational device cohort.
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, as well as
Kaplan-Meier survival at 180 days of 90%, and 86% at 360
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