The Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas, was the first facility in the country to use a new heart catheter device approved by the FDA in August.
TCAI used the Thermocool Smartouch SF Cather is a device designed to treat atrial fibrillation by accurately controlling the amount of contact force applied to a heart wall during radiofrequency catheter ablation procedures, according to a statement from the medical center. It is intended to improve patient outcomes and prevent incomplete lesion formation that can result in the need of additional treatment. The device, manufactured by Biosense Webster, is the only approved device of its kind.
Andrea Natale, MD, a cardiac electrophysiologist and executive medical direct at TCAI, was on a team of researchers who conducted the clinical study on the device, and was also the first to use it during a patient procedure on Aug. 31.
"The Thermocool Smarttouch SF Catheter represents a significant advancement for the clinical community," Natale said. "Numerous trials, including the SMART-AF and SMART-SF studies, have proven that this technology enables physicians to achieve targeted stability in the defined contact force range, leading to shorter procedure times and enhanced results without compromising safety."
In the clinical study, the Thermocool Smarttouch showed that it reduced procedure time by 18.7 percent when compared to a study done on an earlier version of the device. Additionally, the Thermocool showed a 14.2 percent reduction in overall ablation times and a 55.2 percent reduction in fluoscopy time, which limits patients’ exposure to radiation.
The device can be integrated with the Carto 3 System, an imaging technology that combines contact force technology, navigation abilities and 3D mapping.