CardioKinetix has recently announced the results of a meta-analysis study of the catheter-based Parachute Ventricular Partitioning Device. Six-month clinical results from 91 US and European patients with ischaemic heart failure were presented at the 2013 EuroPCR in Paris, France (21–24 May) by Martyn Thomas, chairman of Cardiology at St Thomas’ Hospital in London, UK.
“The results of this meta-analysis, which represents the largest group of patients studied to date, are consistent with previous positive findings and continue to substantiate the Parachute treatment as a viable technology a very exciting prospect for physicians treating patients with heart failure,” said Thomas. “The Parachute promises to revolutionise the treatment for heart attack survivors whose hearts enlarge over time and subsequently suffer from heart failure symptoms, offering hope for a better qualify of life for many patients.”
Clinical data from 91 patients to reach six-month follow-up has demonstrated successful delivery and deployment of the Parachute implant, without the occurrence of major adverse cardiac events related to the device, in 90% (82/91) of patients at six months following treatment. In addition, six months following treatment, 89% of patients demonstrated improved or maintained New York Heart Association (NYHA) functional class status. Specifically in the NYHA III subgroup, 27% improved two classes. The treatment also demonstrated a reduction in left ventricular volume, with a 20% reduction in end diastolic volume and a 23% reduction in end systolic volume (p<0.001).
“The results of this meta-analysis along with the recent completion of our post-market safety surveillance trial add to our excitement about the Parachute treatment, which we believe holds the potential to improve the lives of tens of thousands of patients around the world and reduce the economic burden of heart failure,” said Maria Sainz, president and CEO of CardioKinetix. “Enthusiasm about the therapy continues to grow in the clinical community in Europe, where the Parachute treatment is available commercially, as well as in the USA, where the device is being studied in a landmark randomised pivotal trial.”
The Parachute Ventricular Partitioning Device received CE mark in 2011. In the USA, the Parachute system is an investigational device limited to investigational use only and is not available for sale.