One-year clinical data from European trial shows consistent, compelling positive results for patients treated with minimally invasive device for heart failure

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CardioKinetix has released results of a pooled analysis study of the first-of-its-kind catheter-based Parachute ventricular partitioning device. Twelve-month clinical data from PARACHUTE III, a study of 100 post-market European patients with ischaemic heart failure treated consecutively between 2011 and 2013, were presented at the 2014 TCT Conference in Washington, USA, by Ulrich Schäfer, (cardiology director of the Structural Heart Division at the Heart Center at the University Medical Center Hamburg-Eppendorf)

 

Parachute had a very high procedural success rate of 97% (97/100). The twelve-month highlights from the data include:

  • Primary safety endpoint yielded a low 7% rate of device- or procedure-related MACCE

  • Sustained reduction of left ventricle volumes (p<0.0001) resulting in significant improvements in systolic function and a significant reduction in left atrial volume (p<0.05) reflected improved diastolic function

  • NYHA functional class improved or maintained in 80% of patients

  • Six-minute walk distance improved at follow-up (p<0.01), with 46% 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 9.5% and 26%, respectively.

“The results of this trial add excitement about the Parachute treatment, which offers an option to heart failure patients with a very poor prognosis the promise for improved quality of life and reduced rates of mortality and heart failure hospitalisation,” said Schäfer.


After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged and who suffer from heart failure are limited, with a significant number currently receiving an implantable cardioverter defibrillator (ICD) and approximately one-third receiving a cardiac resynchronisation therapy device (CRT-D) device. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

 

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