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FDA Approval for C-Pulse US Clinical Trial
12 / 09 / 2008
Sunshine Heart (ASX: SHC) announces that it has received conditional approval from the US Food and Drug Administration (FDA) to begin its first US clinical trial for C-PulseT, a heart assist therapy for patients suffering from moderate heart failure.
With FDA conditional approval, Sunshine Heart will now begin to enroll patients in US-based clinical trials. Up to 20 patients suffering from moderate heart failure will be selected to evaluate the safety and effectiveness of the C-Pulse heart assist device.
The FDA approval conditions are acceptable to the Company and will result in minor changes to the clinical protocol, patient record keeping and device labeling.
The Company expects patient enrollment to begin in the fourth quarter of 2008 at six premier US medical institutions. William Abraham, MD, of The Ohio State University, and Patrick McCarthy, MD, of Northwestern University Medical Center, will serve as co-lead national principal investigators. Biographical details on the co-principal investigators are set out below. Each patient will be closely monitored for six months to record the effect of the C-Pulse device.
After completion of this clinical trial, the Company plans to seek CE Mark approval for C-Pulse to enable the device to be marketed in the European Union and other countries accepting CE Mark. The Company will also apply to the FDA for approval to undertake a larger US clinical study as a precursor to gaining approval to market the device in the USA.
Malcolm McComas, Chairman of Sunshine Heart, commented: "This approval is a very significant event for the company. The trials we are about to start will be important next steps in demonstrating the application of our device in the large market of heart failure sufferers. Our first human implant was three years ago in Auckland. To have come this far with a highly innovative new therapy for heart failure in this time is quite an achievement. I acknowledge the work of the Company's engineering team and the regulatory and clinical staff in this achievement."
Donald Rohrbaugh, Chief Executive Officer of Sunshine Heart, said: "Having worked through the rigorous requirements of the FDA, we are very encouraged to have won approval for the clinical trial. The data this study will provide will be most valuable. We believe that C-Pulse represents one of the most innovative therapies for treating heart failure for those patients who no longer receive symptom relief from medication or cardiac synchronization technologies. We recognize the far-sighted support of our shareholders and in particular, our major shareholders GBS Ventures, CM Capital, and Three Arch Partners, and the Commonwealth Government's Commercial Ready Grant program."
Biographical details of Co-Principle Investigators:
William T Abraham, MD, FACC, is Professor of Internal Medicine, Director of the Division of the Cardiovascular Medicine and Deputy Director of the Davis Heart and Lung Research Institute at Ohio State University. Dr Abraham 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).
Patrick M McCarthy, MD is the Heller-Sacks Professor of Surgery, Chief of the Division of Cardiothoracic Surgery and Co-Director of the Bluhm Cardiovascular Institute of the Northwestern University Feinberg School of Medicine. Dr McCarthy is 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.
About Moderate Heart Failure
In moderate heart failure, the heart has lost some 30 - 40% of its capacity to pump blood around the body, and patients suffer symptoms of shortness of breath and fatigue with minimal exertion. Left untreated, moderate heart failure leads to increased hospitalizations and premature death
With FDA conditional approval, Sunshine Heart will now begin to enroll patients in US-based clinical trials. Up to 20 patients suffering from moderate heart failure will be selected to evaluate the safety and effectiveness of the C-Pulse heart assist device.
The FDA approval conditions are acceptable to the Company and will result in minor changes to the clinical protocol, patient record keeping and device labeling.
The Company expects patient enrollment to begin in the fourth quarter of 2008 at six premier US medical institutions. William Abraham, MD, of The Ohio State University, and Patrick McCarthy, MD, of Northwestern University Medical Center, will serve as co-lead national principal investigators. Biographical details on the co-principal investigators are set out below. Each patient will be closely monitored for six months to record the effect of the C-Pulse device.
After completion of this clinical trial, the Company plans to seek CE Mark approval for C-Pulse to enable the device to be marketed in the European Union and other countries accepting CE Mark. The Company will also apply to the FDA for approval to undertake a larger US clinical study as a precursor to gaining approval to market the device in the USA.
Malcolm McComas, Chairman of Sunshine Heart, commented: "This approval is a very significant event for the company. The trials we are about to start will be important next steps in demonstrating the application of our device in the large market of heart failure sufferers. Our first human implant was three years ago in Auckland. To have come this far with a highly innovative new therapy for heart failure in this time is quite an achievement. I acknowledge the work of the Company's engineering team and the regulatory and clinical staff in this achievement."
Donald Rohrbaugh, Chief Executive Officer of Sunshine Heart, said: "Having worked through the rigorous requirements of the FDA, we are very encouraged to have won approval for the clinical trial. The data this study will provide will be most valuable. We believe that C-Pulse represents one of the most innovative therapies for treating heart failure for those patients who no longer receive symptom relief from medication or cardiac synchronization technologies. We recognize the far-sighted support of our shareholders and in particular, our major shareholders GBS Ventures, CM Capital, and Three Arch Partners, and the Commonwealth Government's Commercial Ready Grant program."
Biographical details of Co-Principle Investigators:
William T Abraham, MD, FACC, is Professor of Internal Medicine, Director of the Division of the Cardiovascular Medicine and Deputy Director of the Davis Heart and Lung Research Institute at Ohio State University. Dr Abraham 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).
Patrick M McCarthy, MD is the Heller-Sacks Professor of Surgery, Chief of the Division of Cardiothoracic Surgery and Co-Director of the Bluhm Cardiovascular Institute of the Northwestern University Feinberg School of Medicine. Dr McCarthy is 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.
About Moderate Heart Failure
In moderate heart failure, the heart has lost some 30 - 40% of its capacity to pump blood around the body, and patients suffer symptoms of shortness of breath and fatigue with minimal exertion. Left untreated, moderate heart failure leads to increased hospitalizations and premature death