Positive One-Year Data for Parachute® Structural Heart Device for Heart Failure

It’s eighteen months since we last covered news of the Parachute® Ventricular Partitioning Device from CardioKinetix Inc. Now a pooled analysis study of the first-of-its-kind catheter-based treatment for heart failure has been presented at ACC 2014.

Background

The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle 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. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

Twelve-month clinical results from 111 consecutive U.S. and European patients with ischemic heart failure were presented at the 2014 ACC Conference in Washington, D.C., by Philip Adamson, medical director at the Heart Failure Institute at Oklahoma Heart Hospital.

The results demonstrate that Parachute proves to be a straightforward technology with a very high procedural success rate of 96 percent (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
  • NYHA functional class improved or maintained in 86 percent of patients
  • Six-minute walk distance improved at follow-up (p < 0.05), with 47 percent of patients walking an additional 20 meters or more
  • Rates of death and the combined endpoint of death and repeat hospitalization for heart failure were 5.7 percent and 21.7 percent, respectively

Investigator comments 

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

Company comments

“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 U.S. randomized clinical trial, which is currently enrolling at 45 centers.”

Source: CardioKinetix, Inc., Business Wire

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