Sydney, July 13, 2007 (ABN Newswire) - Following significant shareholder enquiry, the Company provides an update of the status of the international clinical trial currently underway for HeartWare's (ASX: HTW) HVAD TM Left Ventricular Assist Device.
Following recent successful implants at Hannover Medical Centre, Royal Perth Hospital and St Vincent's Hospital in Sydney, the HVAD TM pump has now been implanted in 16 patients. On a cumulative basis these patients have been supported by the device for over 2,400 days. The average support duration across the group exceeds 150 days per patient.
15 out of the 16 patients are alive and well, with all but the three most recent patients having long been discharged from hospital. Of the 16 patients, 7 have now successfully passed the primary endpoint of the clinical trial, namely survival to 180 days or to the point of undergoing heart transplantation. Three of our patients have received heart transplants, after being supported by their pumps for 427, 348 and 157 days respectively.
The pump continues to demonstrate very promising clinical results. We are confident of completing our 20 patient target enrolment in the trial over coming weeks.
About HEARTWARE LIMITED
HeartWare is developing a family of proprietary circulatory assist devices to treat patients with congestive heart failure. HeartWare's lead device, the HVAD, commenced human clinical trials in March 2006. First sales are anticipated in late 2007. With a volume of 45cc, the HVAD is the smallest "3rd generation" pump and the only full output device implantable within the pericardial space.
In parallel with the HVAD clinical development, HeartWare is pursuing its MVAD program, aimed at developing a family of miniaturized cardiac assist devices, implantable by minimally invasive surgical techniques. The current MVAD prototype, approximately one tenth the volume of the HVAD, commenced animal studies in August 2005.
HeartWare listed on the Australian Stock Exchange (ASX: HTW) on 31 January 2005 after successfully raising A$32.4 million (US$24.95 million). HeartWare's Head Office is located in Sydney, Australia.
Contact
www.heartware.com.au Howard Leibman Director Corporate Development HeartWare Limited +61 2 9238 2064 / 0402 440644
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