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|Medtronic Announces Launch of FlexCath Advance™ Steerable Sheath, Enhancing the Arctic Front Advance™ Cryoballoon System|
Second-Generation Sheath May Facilitate Easier Access to the Inferior Veins When Treating Paroxysmal Atrial Fibrillation
MINNEAPOLIS – Jan. 15, 2013 – Medtronic, Inc. (NYSE: MDT) today announced Food and Drug Administration (FDA) clearance and U.S. launch of the FlexCath Advance™ Steerable Sheath, a new enhancement to the Arctic Front Advance™ Cryoballoon System. This second-generation sheath has an increased degree of deflection and response, providing greater ease compared to the previous generation in reaching the inferior veins of the heart when delivering and positioning the cryoballoon catheter in the left atrium to treat paroxysmal atrial fibrillation (PAF).
The Arctic Front Advance System is used in minimally invasive procedures to isolate the pulmonary veins using coolant. Delivered via a catheter, the cryoballoon technology is associated with faster procedure times than point-by-point radiofrequency ablation1, 2, and better treatment outcomes than drug therapies on the market3. Additionally, the Arctic Front Advance cryoballoon features the new EvenCool™ Cryo Technology, which optimizes the delivery of coolant inside the balloon; the larger, more uniform cold surface reduces the effort needed to isolate the pulmonary veins, and improves physicians’ ability to treat patients with complicated anatomies as compared to the original Arctic Front® Cryoballoon.
“The FlexCath Advance sheath’s ability to maneuver the catheter with a greater range of deflection may help reach the inferior veins and facilitate placement of the cryoballoon, which is a critical step to ensuring treatment success,” said Suneet Mittal, M.D., director, Electrophysiology Laboratory, Arrhythmia Institute of the Valley Health System, Ridgewood, NJ.
“Building upon the Arctic Front System’s proven platform, the FlexCath Advance Steerable Sheath augments the overall efficiency of the procedure,” said Reggie Groves, vice president and general manager of Medtronic’s AF Solutions division. “It completes the Arctic Front Advance System and is the fourth new product we have launched in the U.S. market in two years.”
About the Arctic Front Advance System
About Atrial Fibrillation
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1 Kojodjojo P, O’Neill MD, Lim PB, et al. Pulmonary venous isolation by antral ablation with a large cryoballoon for treatment of paroxysmal and persistent atrial fibrillation: medium-term outcomes and non-randomised comparison with pulmonary venous isolation by radiofrequency ablation. Heart. September 2010;96(17):1379-1384.
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