Biosense Webster, Inc. Announces U.S. Launch of THERMOCOOL SMARTTOUCH® SF Catheter

DIAMOND BAR, Calif., Aug. 15, 2016 /PRNewswire/ -- Biosense Webster, Inc., a worldwide leader in the treatment and diagnosis of heart arrhythmias, today announced U.S. approval of the THERMOCOOL SMARTTOUCH^® SF Catheter. The catheter, now available for sale in the United States, is the only approved device pairing contact force technology with a porous tip designed to optimize efficiency. This optimizes efficiency by providing uniform cooling at half the flow rate of earlier generation irrigated catheters, easing the fluid management process. 

"The THERMOCOOL SMARTTOUCH^® SF Catheter is an exciting development for patients and electrophysiologists alike, addressing many of the challenges faced using earlier technologies," said Dr. Larry A. Chinitz, Professor of Medicine and Cardiac Electrophysiology and Clinical Director of the Leon Charney Division of Cardiology at the New York University School of Medicine. "With its combination of contact force technology and porous tip design, the device integrates two important features in a way that will help physicians like myself improve outcomes for patients being treated with catheter ablation."

Clinical data has demonstrated the safety of the device when used to treat drug refractory paroxysmal atrial fibrillation. The SMART-AF trial, a multicenter, prospective study of the earlier generation THERMOCOOL SMARTTOUCH^® technology, revealed no unanticipated adverse events and demonstrated a success rate of greater than 80 percent, with increased stability within the contact force range. The more recent SMART-SF study, which tested the newest generation THERMOCOOL SMARTTOUCH^® SF Catheter, demonstrated excellent safety results as well. The study found an 18.7 percent reduction in overall procedure time and a 14.2 percent reduction in overall ablation time when compared to the SMART-AF study. It also demonstrated a 55.2 percent reduction in total fluoroscopy time, limiting radiation exposure to patients.

"The THERMOCOOL SMARTTOUCH^® SF Catheter represents a significant advancement for the clinical community," said Dr.Andrea Natale, Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David's Medical Center in Austin, Texas. "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."

The catheter is seamlessly integrated with the CARTO^® 3 System, which combines contact force technology, 3-D mapping and advanced navigation capabilities to provide active measurement of stable contact force and catheter tip location.

"The launch of the THERMOCOOL SMARTTOUCH^® SF Catheter reflects our ongoing commitment to addressing unmet needs in the cardiovascular space," said David Shepherd, U.S. President of Biosense Webster, Inc. "With this approval, we are pleased to continue expanding customer access to innovative technologies that facilitate the diagnosis and treatment of patients with heart rhythm disorders."

The THERMOCOOL SMARTTOUCH^® SF Catheter is available for commercial sale in the United States and Europe.

Source: Biosense Webster, Inc.