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Sunshine Heart Completes Training for US Feasibility Trial
03 / 05 / 2007
Sunshine Heart, Inc. (ASX: SHC) announced today the completion of training of clinicians and other healthcare professionals at the six US medical centres scheduled to participate in the US Feasibility Clinical Trial of the company''s C-PulseT heart assist device.
The training program was held in conjunction with the recent International Society of Heart and Lung Transplantation meeting in San Francisco. This program was a key step in preparation for the US Clinical Trial that is scheduled to commence in the second half of 2007 at internationally recognised research hospitals and medical centres that specialise in heart failure and cardiovascular diseases.
Heart failure cardiologists and cardiothoracic surgeons were among the 30 people involved in the C-PulseT training program. Representatives attended from each of the sites that will participate in the trial:
Ohio State University Medical Center (Columbus, Ohio)
Northwestern University Feinberg School of Medicine (Chicago, Illinois)
Pennsylvania State University's Milton Hershey School of Medicine (Hershey, Pennsylvania)
University of Florida College of Medicine (Gainesville, Florida)
University of Louisville-Jewish Hospital (Louisville, Kentucky)
University of Alabama at Birmingham (Alabama).
As Dr Abraham, a national co-principal investigator of the Clinical Trial, told the trainees:
"Despite available therapies, up to forty percent of patients are moderately or severely disabled by systolic heart failure. There is a need for additional therapies to improve the status of patients. This approach to heart failure management using the C-PulseTM has the potential to improve poor cardiac output."
Dr McCarthy, the other national co-principal investigator, said: "I am looking forward to offering mechanical support without the risks inherent in VAD technology, to much earlier heart failure patients."
The lecturers including Sunshine Heart's Medical Director Dr William Peters, other members of the Sunshine Heart staff and other clinicians who have had direct experience of the C-PulseTM during the Pilot clinical trials in Australia and New Zealand, covered a range of topics, including patient management and surgical implant of CPulse T, clinical study design, protocol and reimbursement procedures.
"The participation of these prestigious physicians and their institutions in the C-PulseT clinical trial signals the clinical need for C-PulseT and, by extension, the market potential for C-PulseT at the completion of clinical development," said Donald Rohrbaugh, the Chief Executive Officer of Sunshine Heart.
The training program was held in conjunction with the recent International Society of Heart and Lung Transplantation meeting in San Francisco. This program was a key step in preparation for the US Clinical Trial that is scheduled to commence in the second half of 2007 at internationally recognised research hospitals and medical centres that specialise in heart failure and cardiovascular diseases.
Heart failure cardiologists and cardiothoracic surgeons were among the 30 people involved in the C-PulseT training program. Representatives attended from each of the sites that will participate in the trial:
Ohio State University Medical Center (Columbus, Ohio)
Northwestern University Feinberg School of Medicine (Chicago, Illinois)
Pennsylvania State University's Milton Hershey School of Medicine (Hershey, Pennsylvania)
University of Florida College of Medicine (Gainesville, Florida)
University of Louisville-Jewish Hospital (Louisville, Kentucky)
University of Alabama at Birmingham (Alabama).
As Dr Abraham, a national co-principal investigator of the Clinical Trial, told the trainees:
"Despite available therapies, up to forty percent of patients are moderately or severely disabled by systolic heart failure. There is a need for additional therapies to improve the status of patients. This approach to heart failure management using the C-PulseTM has the potential to improve poor cardiac output."
Dr McCarthy, the other national co-principal investigator, said: "I am looking forward to offering mechanical support without the risks inherent in VAD technology, to much earlier heart failure patients."
The lecturers including Sunshine Heart's Medical Director Dr William Peters, other members of the Sunshine Heart staff and other clinicians who have had direct experience of the C-PulseTM during the Pilot clinical trials in Australia and New Zealand, covered a range of topics, including patient management and surgical implant of CPulse T, clinical study design, protocol and reimbursement procedures.
"The participation of these prestigious physicians and their institutions in the C-PulseT clinical trial signals the clinical need for C-PulseT and, by extension, the market potential for C-PulseT at the completion of clinical development," said Donald Rohrbaugh, the Chief Executive Officer of Sunshine Heart.