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HeartWare Completes GLP Studies of Next Generation MVAD® Pump; Data Presented Today at ISRBP Congress
Date:9/9/2011

LOUISVILLE, Ky., Sept. 9, 2011 /PRNewswire/ -- Data presented today at the 19th Congress of the International Society for Rotary Blood Pumps (ISRBP) demonstrated that the HeartWare MVAD® Pump attained the objectives for system performance, hemocompatability and biocompatibility in Good Laboratory Practice (GLP) animal studies, a significant step prior to commencement of human clinical studies.

(Photo:  http://photos.prnewswire.com/prnh/20110909/LA65433)

HeartWare's MVAD Pump is a development-stage miniature ventricular assist device, approximately one-third the size of HeartWare's HVAD® Pump.  The MVAD is based on the same proprietary impeller suspension technology used in the HVAD Pump, with its single moving part held in place through a combination of passive-magnetic and hydrodynamic forces.  Like the HVAD Pump, the MVAD Pump is designed to support the heart's full cardiac output, yet also has the capability for partial support.

"The MVAD was successfully implanted via a left thoracotomy, without cardio-pulmonary bypass, and exhibited excellent blood handling characteristics during the course of the study," said Edwin C. McGee, Jr., M.D., Surgical Director, Heart Failure, Heart Transplantation, and Mechanical Assistance; Bluhm Cardiovascular Institute, Northwestern Memorial Hospital and Associate Professor, Northwestern University's Feinberg School of Medicine, Chicago.  "At the 90-day explant date, there was no evidence of device wear or thrombus, and end-organ gross and histological results were positive."

"We're pleased with these results and are appreciative of the efforts of Dr. McGee and our investigators," stated Doug Godshall, President and Chief Executive Officer of HeartWare International.  "Based on these successful outcomes, we remain on track to commence human clinical studies of the MVAD System, wi
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SOURCE HeartWare International, Inc.
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