SUNSHINE HEART: ‘MOST IMPROVE’ IN 20-PATIENT CARDIAC TRIAL
September 25th 2011 22:21
Monday September 12, 2011
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SUNSHINE HEART
Sunshine Heart says that most of the 20-patients in its pilot trial of the C-Pulse aorta cuff pump improved heart failure categories.
Sunshine Heart did not provide detailed results, but said that one patient died in an infection-related operation and two patients improved to the point that they were disconnected permanently from the heart pump system.
The summarized data was published by the Ohio State University Medical Center and the company said the detailed results would be presented at the Transcatheter Cardiovascular Therapeutics meeting in San Francisco on November 8, 2011.
Ohio State University Medical Center said that 20 patients, eight women and 12 men with an average age of 56, were enrolled in the trial, of which 18 were classified with New York Heart Association (NYHA) class III heart failure and two were class IV, the most severe forms of heart failure.
All patients had cardiac resynchronization therapy, implantable cardiac defibrillators or combination devices implanted, the Medical Center said.
The Medical Centre said three patients were successfully bridged to transplant with one patient being supported for 22 months, the longest of any patient participating in the trial.
The Medical Centre said that all but one patient either improved or maintained NYHA heart failure classification.
Sunshine Heart chief executive officer Dave Rosa told Biotech Daily that the results were still being finalized, with some detail being held back for the San Francisco conference.
“The majority of patients improved, rather than maintained classification, and this is a condition in which patients normally deteriorate,” Mr Rosa said.
Mr Rosa said that two patients improved to the point that they did not require the device, due to the absence of heart failure symptoms, and along with the overall reduction in patient medication, were positive indicators for the device.
Mr Rosa said that one patient was disconnected after the six month follow-up and the second patient after 11 months on therapy.
The Medical Centre said that overall, other improvements were realized as measured by quality of life scores, six-minute walk times, ejection fractions, or the heart’s pumping ability, and reductions in medications.
Mr Rosa said that the patient who died had a non-device-related infection and died following surgery to treat the infection.
Mr Rosa said there were a number of contributing factors in the death from an aortic disruption, as a result of a re-sternotomy surgery to treat the procedure-related infection.
The Medical Centre said no neurologic events or heart attacks were reported, while six superficial exit site infections were successfully treated with antibiotics.
The Medical Centre said there was one instance of post-operative, non-device related bleeding.
The Medical Centre said that the results warranted a larger pivotal trial.
The Medical Centre’s director of cardiovascular medicine and co-lead principal investigator Dr William Abraham said the trial results to date “show positive trends of efficacy with a strong safety profile as compared to later stage mechanical support devices”.
“We believe further investigation is needed as hundreds of thousands of heart failure patients in this country remain substantially symptomatic despite currently available treatments,” Dr Abraham said.
The C-Pulse aorta cuff uses an electrocardiogram-sensing wire to inflate and deflate the cuff to assist the heart, reducing aortic pressure and the heart’s workload.
Sunshine Heart was unchanged at 4.7 cents.
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