The Food and Drug Administration approved the Thermocool SmartTouch SF Catheter to treat patients with heart rhythm disorders.
The device, created by Diamond Bar, Calif.-based Biosense Webster, includes a porous tip design and provides uniform cooling at half the flow rate of previous irrigated catheters to ease the fluid management process.
The catheter also pairs with the CARTO 3 System, which offers contact force technology, 3-D mapping and advanced navigation capabilities to provide clinicians with accurate measurements of stable contact force and catheter tip location.
"Conducted trials, including the SMART-AF and SMART-SF studies, have shown Biosense Webster technology enables physicians to achieve targeted stability in the defined contact force range, leading to shorter procedure times and enhanced results without compromising safety," said Andrea Natale, MD, executive medical director of the Texas Cardiac Arrhythmia Institute at St. David's Medical Center inAustin, Texas.
The Themocool SmartTouch SF Catheter device is already available for sale in the U.S.
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