News | Heart Failure | January 15, 2016

CardioKinetix Reaches Half Enrollment for Parachute Device U.S. Pivotal Trial

Multidisciplinary heart team evaluating patients for enrollment in study of catheter-based heart failure device

CardioKinetix, Parachute device, heart failure, PARACHUTE IV trial, half enrollment

January 15, 2016 — CardioKinetix Inc. announced that it has enrolled more than half of the subjects in its pivotal United States trial, PARACHUTE IV. The trial is evaluating the Parachute device for the treatment of patients suffering from heart failure, a highly debilitating condition.

After a heart attack, many patients experience enlargement of their left ventricle. This causes a decrease in cardiac output and results 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.

William Abraham, M.D., from the Ohio State University, Marco Costa, M.D., Ph.D., from University Hospitals, Case Western Reserve University, and Leslie Saxon, M.D., from the University of Southern California, provide physician leadership for the trial. A multidisciplinary approach similar to other novel structural heart therapies is optimal for success. 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, professor of internal medicine and director of the Division of Cardiovascular Medicine at Ohio State University Medical Center. “The Parachute is an innovative device that holds promise as a breakthrough treatment that could transform quality of life for these patients.”

The Parachute 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 U.S., the system is an investigational device limited by federal law to investigational use only and is not available for sale. Currently CardioKinetix is enrolling an IDE study in the United States.

For more information: www.cardiokinetix.com

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
Overlay Init