CardioKinetix Announces US Pivotal Trial More Than Half Enrolled

CardioKinetix Inc. has enrolled more than half of the subjects in its pivotal United States trial, Parachute IV, a trial that is evaluating the Parachute device to treat heart failure patients.

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, fatigue, swelling in the legs, ankles and feet, rapid or irregular heartbeat, and reduced ability to exercise. 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, according to company executives.

Dr. William Abraham from the Ohio State University, Dr. Marco Costa from University Hospitals, Case Western Reserve University, and Dr. Leslie Saxon from the University of Southern California provide physician leadership for the trial. The Parachute Heart Team leverages heart failure, interventional cardiology and electrophysiology experts to identify patients with ischemic etiology and reduced ejection fraction for enrollment.

“As a physician, I am often frustrated that there is not more that I can do for my patients with heart failure following a heart attack to improve debilitating symptoms,” said Abraham, M.D., a professor of internal medicine and director of the Division of Cardiovascular Medicine at Ohio State University Medical Center. “The Parachute is a device that holds promise as a breakthrough treatment that could transform quality of life for these patients.”

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 worldwide are affected.

“We are pleased to have reached this milestone in the U.S. trial, and are looking forward to completing the enrollment phase. We are very excited with the interest in our therapy from interventional cardiologists, heart failure specialists and electrophysiologists,” said Maria Sainz, president/CEO of CardioKinetix. “This achievement was accomplished by the strong partnerships with our more than 60 clinical sites.”

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. The procedure is performed in the catheterization laboratory under limited sedation. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the United States, the Parachute system is an investigational device and is not available for sale. Currently CardioKinetix is enrolling an IDE study in the United States.

Based in Menlo Park, Calif., CardioKinetix has developed the catheter-based Parachute Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors, Tekla Life Sciences Investors, SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.