CardioKinetix has reported positive results from a pooled analysis study of the first-of-its-kind catheter-based Parachute ventricular partitioning device designed to treat patients with heart failure caused by damage to the muscle following a heart attack.
Oklahoma Heart Hospital Heart Failure Institute medical director Dr Philip Adamson has presented the one-year clinical results from 111 consecutive US and European patients with ischemic heart failure at the 2014 ACC Conference in Washington DC.
Dr Adamson said the results of this pooled analysis, which represents the largest group of patients studied to date, continue to substantiate the Parachute treatment as a viable technology for patients with heart failure.
"As we analyse the longer time points in this population, we are beginning to observe the durable effects of the Parachute device," he said.
According to the company, Parachute proves to be a straightforward technology with a very high procedural success rate of 96% (106/111).
The one-year highlights from the data include sustained reduction of left ventricle volumes, NYHA functional class improved or maintained in 86% of patients; six-minute walk distance improved at follow-up, rates of death and the combined endpoint of death and repeat hospitalization for heart failure were 5.7% and 21.7%, respectively.
CardioKinetix president and CEO Maria Sainz said: "As we amass more and more data with this technology, enthusiasm and confidence continue to build around the landmark US randomised clinical trial, which is currently enrolling at 45 centres."
The Parachute is a catheter based partitioning device deployed within the left ventricle through a small catheter inserted in the femoral artery of patients who have developed ischemic heart failure following a heart attack.
By partitioning damaged muscle and isolating the non-functional muscle segment from the functional segment, the Parachute implant decreases the overall volume and restores a more normal geometry and function in the left ventricle.
The Parachute device helps in achieving better patient outcomes as it improves overall cardiac function and quality of life of patients.
In 2011, the company obtained a first received CE Mark for its Parachute ventricular partitioning device.
In the US, the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.