One-Year clinical data show positive results for patients treated with minimally invasive structural heart device


CardioKinetix announced results of a pooled analysis study of the first-of-its-kind catheter-based Parachute ventricular partitioning device. Twelve-month clinical results from 111 consecutive US and European patients with ischaemic heart failure were presented at the 2014 American College of Cardiology (ACC) Conference in Washington, DC, USA, by Philip Adamson, medical director at the Heart Failure Institute at Oklahoma Heart Hospital.

“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,” says Adamson. “As we analyse the longer time points in this population, we are beginning to observe the durable effects of the Parachute device.”

CardioKinetix reports that Parachute proves to be a straightforward technology with a very high procedural success rate of 96% (106/111). The twelve-month highlights from the data include:

• Sustained reduction of left ventricle volumes (p < 0.0001) resulting in significant improvements in systolic function (ejection fraction, contractility index, and stroke work) and a significant reduction in left atrial volume reflected improved diastolic function

• New York Heart Association (NYHA) functional class improved or maintained in 86% of patients

• Six-minute walk distance improved at follow-up (p < 0.05), with 47% of patients walking an additional 20 metres or more

• Rates of death and the combined endpoint of death and repeat hospitalisation for heart failure were 5.7% and 21.7%, respectively

“The results of this analysis add 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. “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 ventricular partitioning device first received CE mark approval in 2011. In the USA, the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.