March 28, 2011 – The Therapeutic Goods Administration (TGA) of Australia has approved the HeartWare Ventricular Assist System for listing on the Australian Register of Therapeutic Goods (ARTG).
"As we seek to expand the global commercial markets for our miniaturized circulatory support device, this milestone has special meaning for HeartWare," said Doug Godshall, president and CEO. "Royal Perth Hospital and St. Vincent's Hospital in Australia are two of our five initial clinical sites, we first listed HeartWare shares on the Australian Securities Exchange, and the clinical and financial communities within Australia have strongly supported our growth for many years."
Today, more than 900 advanced heart failure patients globally have received the HVAD pump. HeartWare received CE Marking in 2009 in the European Union, and in late December 2010, filed a Pre-Market Approval (PMA) application in the United States with the Food and Drug Administration.
For more information: www.heartware.com