Heart Failure Experts Appointed As Co-Principal Investigators For Sunshine Heart Company Pty Limited's United States Feasibility Trial
SYDNEY, Australia, Feb. 22 /PRNewswire-FirstCall/ -- Sunshine Heart is pleased to announce that Dr William T Abraham of Ohio State University, Columbus, Ohio and Dr Patrick M McCarthy of Northwestern University, Chicago, Illinois have agreed to become the Co-Principal Investigators for the C-Pulse(TM) Feasibility Trial in the United States.
The appointment of Drs Abraham and McCarthy continues Sunshine Heart's progress towards commencing the multi-centre US Feasibility Trial during 2007 following the positive meeting with the FDA (United States Food and Drug Administration) that was announced on 22 December 2006.
Chief Executive Officer of Sunshine Heart Donald Rohrbaugh said, "The participation of Drs Abraham and McCarthy as Co-Principal Investigators with their combined experience in the management of heart failure and expertise as clinical investigators will add great credibility to the C-Pulse(TM) trial within the international medical community."
Dr Abraham, who has participated in more than 100 drug and device clinical trials and has been International Principal or Co-Principal Investigator for several of Medtronic's heart failure pacemaker trials (Miracle, Miracle ICD), said, "The C-Pulse(TM) has great potential in the treatment of patients with moderately severe heart failure."
William T Abraham, MD FACP, FACC, FAHA is Professor of Internal Medicine, Division Director of Cardiovascular Medicine and Deputy Director of the Davis Heart and Lung Research Institute at Ohio State University.
Patrick M McCarthy, MD is the Heller-Sacks Professor of Surgery, Division Chief of Cardiothoracic Surgery and Co-Director of the Bluhm Cardiovascular Institute of the Northwestern University Feinberg School of Medicine. Dr McCarthy has been recognized as an innovative and leading cardiovascular surgeon and researcher. He has been a clinical investigator in trials of several heart assist devices and is Chairman of the Society of Thoracic Surgeons/American Association for Thoracic Surgery Joint Working Group on New Technology.
Dr McCarthy recently presented the C-Pulse(TM) at University's Heart Failure Summit, in "The Future of Congestive Heart Failure" Session.
For further information, please visit www.sunshineheart.com or contact: Media Daniella Goldberg PhD +612 9237 2803 dgoldberg@bcg.com.au Sunshine Heart Victor Windeyer Chief Operating Officer +61 2 8424 7700 victor.windeyer@sunshineheart.com Don Rohrbaugh Chief Executive Officer +1 714 665 1951 don.rohrbaugh@sunshineheart.com Images of the C-Pulse(TM) are available upon request
Sunshine Heart (www.sunshineheart.com ) is a global medical device company, committed to the commercialization of the C-Pulse(TM), an implantable, non-blood contacting, mechanical heart assist device for the treatment of people with heart failure. Sunshine Heart was formed in Australia in 1999 and incorporated as Sunshine Heart, Inc. in Delaware (US) in 2002. The Company was listed on the Australian Stock Exchange (ASX) in September 2004 and has a presence in the United States, Australia and New Zealand.
Sunshine Heart has completed an intra-operative feasibility study [1] and is currently conducting a multi-centre chronic Pilot Clinical Trial in Australia and New Zealand.
Heart failure is a progressively worsening condition characterized by shortness of breath with mild exercise, fatigue, dizziness and fluid retention. Heart failure is caused by the inability of the heart to pump sufficient blood around the body to meet its oxygen requirement. In the US, an excess of 5 million people have heart failure.
The C-Pulse(TM) is an implantable, non-blood contacting mechanical heart assist device designed to provide long term support for people with moderate to severe (Class III) heart failure. The device is designed to be implanted without the need for bypass and does not contact the bloodstream, reducing the risk of bleeding and blood clot formation.
The C-Pulse(TM) Cuff consists of a wrap and a balloon which is placed around the aorta just above the heart. The balloon is inflated and deflated to the rhythm of the heart to improve blood supply to both the body and the heart muscle, while reducing the workload on the heart.
The C-Pulse(TM) Driver is an external wearable unit that is linked by an air tube to the cuff and detects the heart's natural rhythm and controls inflation and deflation of the balloon in rhythm with the heart.
Implantation of the C-Pulse(TM) involves wrapping the cuff around the aorta. No incisions into the aorta are needed so that the device never comes into contact with the patient's bloodstream. The C-Pulse(TM) balloon inside the cuff is designed to inflate in a way that rolls the wall of the aorta inward in a gentle 'thumb printing' manner. The balloon is inflated and deflated rhythmically to improve blood supply to the heart and body as well as reduce the workload of the heart.
[1] Legget ME, Peters WS, Milsom FP, et al. Extra-aortic balloon counterpulsation -- an intra-operative feasibility study. Circulation 2005;112[suppl I]:I-26-I-31
This press release contains forward-looking statements that are based on current management expectations. These statements may differ materially from actual future events or results due to certain risks and uncertainties from time to time in the Company's filings with the Australian Stock Exchange.
Sunshine Heart Inc.
CONTACT: Media, Daniella Goldberg PhD, +612-9237-2803,dgoldberg@bcg.com.au; or Victor Windeyer, Chief Operating Officer,+61-2-8424-7700, victor.windeyer@sunshineheart.com, or Don Rohrbaugh, ChiefExecutive Officer, +1-714-665-1951, don.rohrbaugh@sunshineheart.com, bothof Sunshine Heart
Web site: http://www.sunshineheart.com/