July 22, 2016 — CardioKinetix Inc. announced this week that 500 patients have received the company’s Parachute Ventricular Partitioning Device for heart failure. Patients have been treated in more than 15 countries, including patients in key international markets where the device is commercially available, and patients enrolled in PARACHUTE IV, the company’s U.S. pivotal trial under investigational device exemption (IDE).
After a heart attack, many patients experience enlargement of the left ventricle. This enlargement causes 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 what the company calls the first minimally invasive catheter-based treatment designed 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.
“Heart failure is a large area of fast-growing unmet need, both clinically and from a health economics perspective,” said William Abraham, M.D., of Ohio State University Medical Center. “Patients with heart failure suffer from debilitating symptoms and have few effective treatment options, and the results to date in the Parachute studies are very encouraging. It is important for the medical community to collaborate in completing this pivotal study to further the treatment options for heart failure patients.”
Clinical data supporting the use of the Parachute device has been published in 35 peer-reviewed journals. Two-year safety and efficacy results from 100 European patients treated with the Parachute device were presented at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference in October 2015.
PARACHUTE IV, a large-scale, multi-center, randomized trial, is presently enrolling patients at over 70 treatment centers in the United States. The trial is more than 50 percent enrolled and is led by three national principal investigators: Abraham, Marco Costa, M.D., Ph.D., Case Western Reserve University; and Leslie Saxon, M.D., University of Southern California.
For more information: www.cardiokinetix.com