Sunshine Heart sees positive results in heart pump trial
Feasibility trial shows Sunshine Heart's (ASX:SHC) C-Pulse heart pump significantly improved heart function, setting the stage for more thorough testing in 2012.
Dylan Bushell-Embling (Australian Life Scientist)10 November, 2011 10:09
Sunshine Heart (ASX:SHC) has revealed promising results from early trials of its C-Pulse Heart Assist System in the US.
Of the 20 patients involved in a feasibility trial of the left ventricle pump, all but one stayed stable or showed signs of improvement at a six month follow-up.
Nearly all showed signs of maintained or improved fitness and quality of life, the company said in a presentation of the results at this week's Transcatheter Cardiovascular Therapeutics Conference in San Francisco.
Pre-implant, the patients had all been suffering Class III or IV heart failure, by New York Heart Association metrics. At six month follow-up, four had been upgraded to Class I and two had been removed from therapy due to improvements.
But one patient in the trial died from complications of a wound infection resulting from the sternotomy at implant.
The fatality notwithstanding, co-lead principal investigator Dr William Abraham said the results of the trial “support the preliminary assessment of the safety and efficacy of the device.” Abraham is director of cardiovascular medicine at Ohio State University Medical Center.
According to Sunshine Heart CEO Dave Rosa, with the groundwork complete, the company now plans to apply for permission from the US FDA to conduct a more comprehensive trial in 2012.
Sunshine Heart has corporate offices in both Sydney and Minnesota, and is dual-listed on the ASX and the NASDAQ.
Sunshine Heart (ASX:SHC) shares stayed unchanged in Wednesday's trading at $0.040, down from a six-month high of $0.056.
Add to My Watchlist
What is My Watchlist?