CardioKinetix Releases One-Year Clinical Data Showing Consistent, Compelling Positive Results for Patients Treated with Minimally Invasive Structural Heart Device for Heart Failure
Analysis from 111 Consecutive Patients Presented at ACC 2014 Substantiate Potential of Breakthrough Treatment for Heart Failure Patients
Menlo Park, Calif. – April 7, 2014 – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today 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 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 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.”
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
“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.”
After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. 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.
About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]
About the Parachute® Ventricular Partitioning Device
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.
The Parachute Ventricular Partitioning Device first received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.
About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Archer Ventures, Panorama Capital, H&Q Healthcare Investors (NYSE:HQH), and H&Q Life Sciences Investors (NYSE:HQL). For more information please visit www.cardiokinetix.com.