News | Heart Failure | July 22, 2016

CardioKinetix Announces 500th Parachute Heart Failure Device Implantation

PARACHUTE IV trial in the United States has reached 50 percent enrollment

CardioKinetix, Parachute device, heart failure, 500th implantation, PARACHUTE IV Trial

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:

Related Content

Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Heart Failure Market to Surpass $16 Billion by 2026
News | Heart Failure| September 19, 2017
The heart failure space across the seven key markets of the U.S., France, Germany, Italy, Spain, the U.K. and Japan is...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
TCT 2017 late-breaking trials and studies that will be presented on the latest cardiology technology clinical trials.
Feature | September 11, 2017
September 11, 2017 — From numerous high-quality submissions, Transcatheter Cardiovascular Therapeutics (TCT) has sele
LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

Feature | Left Atrial Appendage (LAA) Occluders| September 07, 2017
September 7, 2017 — Closure of the left atrial appendage (LAA) during heart surgery protects the brain, according to
Protembis Announces Successful First-in-Human Use of  ProtEmbo Cerebral Protection System in European Trial
News | Embolic Protection Devices| September 07, 2017
Protembis GmbH announced the first clinical applications of its ProtEmbo Cerebral Protection System to complement a...
Siemens Healthineers Receives FDA Clearance for TrueFusion Structural Heart Disease Feature
Technology | Cardiovascular Ultrasound| September 06, 2017
The U.S. Food and Drug Administration (FDA) has cleared TrueFusion, a new cardiovascular application from Siemens...
Heart Failure Patients, Clinicians Have Differing Perceptions of Risk Level
News | Heart Failure| September 06, 2017
September 6, 2017 — Physicians identified a majority of patients with advanced...
Overlay Init