Medtronic Announces U.S. Trial of Device to Close the Left Atrial Appendage
May 11, 2009 - Medtronic Inc. today announced the successful implant of its Cardioblate Closure Left Atrial Appendage Occlusion Device by Patrick McCarthy, M.D., co-director of the Bluhm Cardiovascular Institute at Northwestern Memorial Hospital in Chicago, Ill., as part of a U.S. clinical trial.
The study is being conducted under an investigational device exemption (IDE) and the device is limited to investigational use in the U.S.
Published literature suggests the left atrial appendage (LAA) is the main source of clots coming from the left atrium. Patients with an arrhythmia known as atrial fibrillation (AF) have an increased risk of clot formation as a result of the uncoordinated and fast beating of the heart’s upper chambers, which may lead to blood pooling in the LAA. AF is a recognized independent risk factor for stroke and approximately 35 percent of patients with this irregular heart rhythm will have a stroke during their lifetime.
The trial involves five U.S. centers and will evaluate occlusion of the left atrial appendage with the Cardioblate Closure device in patients undergoing valve replacement, valve repair or coronary bypass surgery.
“The clinical community urgently needs safe and proven therapies to achieve permanent closure of the left atrial appendage,” said Dr. McCarthy, the clinical trial’s principal investigator. “Designed to enable easy positioning for safe and complete occlusion of the left atrial appendage, this new device shows considerable promise.”
Unlike competitor alternatives, Medtronic’s Cardioblate Closure device is intended to occlude the LAA permanently without the need to enter the heart and does not introduce man-made materials into the blood stream. It is designed to be pliable and atraumatic to ensure no collateral damage to surrounding structures of the heart, unlike rigid epicardial occlusion devices.
For more information: www.medtronic.com