News | May 11, 2009

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

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