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Continued Advancement in Heart Failure Therapies
17 / 12 / 2007
Sunshine Heart, Inc. (ASX: SHC) welcomed Thoratec Corporation's (NASDAQ: THOR) achievement of another milestone in the market growth of heart failure therapies. A U.S. Food & Drug Administration (FDA) advisory panel recommended unanimously that the agency approve, with conditions, the U.S. marketing of the Thoratec Heartmate II VAD (ventricular assist device) as a bridge-to-transplant device.
The Heartmate II is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure (NYHA Class IV patients).
Dr. William Peters, Medical Director of Sunshine Heart commented, "We are very pleased with the FDA advisory panel recommendation and believe it represents a major step in recognizing the growing epidemic of heart failure and the need for additional heart failure therapies." Dr. Peters continued, "We are confident that our C-PulseT heart assist device, which has been designed and validated for an earlier class of heart patients than the advanced stage patients Thoratec's Heartmate II targets, addresses a much larger patient population. Based upon the clinical experiences with the C-Pulse in Australia and New Zealand, we believe that the treatment of patients earlier with C-Pulse delays (or perhaps reverses) the progressive nature of the heart failure condition and allows patients to improve their quality of life."
The Heartmate II is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure (NYHA Class IV patients).
Dr. William Peters, Medical Director of Sunshine Heart commented, "We are very pleased with the FDA advisory panel recommendation and believe it represents a major step in recognizing the growing epidemic of heart failure and the need for additional heart failure therapies." Dr. Peters continued, "We are confident that our C-PulseT heart assist device, which has been designed and validated for an earlier class of heart patients than the advanced stage patients Thoratec's Heartmate II targets, addresses a much larger patient population. Based upon the clinical experiences with the C-Pulse in Australia and New Zealand, we believe that the treatment of patients earlier with C-Pulse delays (or perhaps reverses) the progressive nature of the heart failure condition and allows patients to improve their quality of life."