Healthcare Industry News: Left Atrial Appendage
News Release - May 8, 2009
Medtronic Announces U.S. Trial of Unique Therapy for Closure of the Left Atrial Appendage
Cardioblate(R) Closure(TM) Device Isolates Heart Appendage Where Dangerous Clots Could FormMINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE: MDT ) announced today the successful implant of its Cardioblate Closure Left Atrial Appendage Occlusion Device by Dr. Patrick McCarthy, 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 United States.
Published literature suggests that 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.
Dr. Patrick McCarthy, the clinical trial’s principal investigator, said, “The clinical community urgently needs safe and proven therapies to achieve permanent closure of the Left Atrial Appendage. 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.
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.
Source: Medtronic
Issuer of this News Release is solely responsible for its
content.
Please address inquiries directly to the issuing company.
Related News Items
Affera(TM) momentum continues as Medtronic announces CE Mark in Europe and U.S. IDE First Cases for Sphere-360™ PFA Catheter to Treat Paroxysmal Atrial FibrillationRestore Medical Appoints Former Medtronic Executive Chris Cleary as Chairman of the Board
Medtronic Initiates U.S. IDE Clinical Study Evaluating Hugo(TM) Robotic-Assisted Surgery System for Gynecological Procedures
