Sydney, May 22, 2006 AEST (ABN Newswire) - HeartWare (ASX: HTW) is pleased to announce that it has received regulatory approval from the Medicines and Healthcare Products Regulatory Agency ("MHRA") to commence implants of its HVAD circulatory assist device in the United Kingdom.
HeartWare's submissions to the MHRA followed receipt of Ethics Committee Approval from Harefield Hospital, one of the four hospitals that will be participating in the clinical trial currently underway for the HVAD.
The HVAD implant program in the UK will be led by Mr Asghar Khaghani, Consultant Cardiac Surgeon at the Royal Brompton and Harefield Hospital Trust. Mr Khaghani is in charge of the cardiac transplantation and mechanical circulatory assist programs at Harefield Hospital and has extensive experience with a wide range of implantable circulatory assist devices. Mr Khaghani is also a member of HeartWare's Medical Advisory Board.
HeartWare now has approvals to implant the HVAD in Austria, Australia and the UK. In addition, HeartWare has received approval from the Ethics Committee at the Hanover Medical Centre in Germany and has completed its submissions to the German regulatory authority. Approval to implant in Germany is anticipated in coming months.
With implants of the HVAD now underway at the Vienna General Hospital in Austria, HeartWare's key priority for 2006 is the enrolment of all twenty patients across the four participating centres. As previously advised, Royal Perth Hospital will be the second centre to begin implanting the HVAD. Royal Perth will be followed by Harefield Hospital and finally by Hanover Medical Centre, subject to receipt of regulatory approval in Germany.
Contact
www.heartware.com.au
Howard Leibman
Director Corporate Development
HeartWare Limited
TEL: +61 2 8215 7604 / 0402 440644
Stuart Barton
Gavin Anderson & Company
TEL: +61 2 9552 4499 / 0404 054 857
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