FDA approves BioSense Webster’s Thermocool SmartTouch catheter

Johnson & Johnson (NYSE:JNJ) subsidiary Biosense Webster said today it won FDA premarket approval for its Thermocool SmartTouch SF catheter designed for ablation procedures.

The Diamond Bar, Calif-based company touted the Thermocool SmartTouch as the only FDA-approved catheter ablation device designed to combine contact force technology and a porous tip.

“The Thermocool SmartTouch SF Catheter represents a significant advancement for the clinical community. 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,” Dr. Andrea Natale of Austin, Texas’ St. David’s Medical Center said in a press release.

Biosense Webster touted data from a clinical study of the device during use treating drug refractory paroxysmal atrial fibrillation, which indicated a success rate of greater than 80% with no unanticipated adverse events.

A more recent study which investigated a newer generation Thermocool SmartTouch catheter indicated an 18.7% reduction in overall procedure time and a 14.2% reduction in overall ablation time compared to the earlier version.

“The launch of the Thermocool SmartTouch SF Catheter reflects our ongoing commitment to addressing unmet needs in the cardiovascular space. 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,” U.S. prez David Shepherd said in prepared remarks.

The catheter is designed to be integrated into the company’s Carto 3 system, which includes 3-D mapping and navigation capabilities to measure contact force and catheter tip location.

“The Thermocool SmartTouch SF Catheter is an exciting development for patients and electrophysiologists alike, addressing many of the challenges faced using earlier technologies. 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,” Dr. Larry Chinitz of the New York University School of Medicine said in a prepared statement.

Last November, Biosense Webster said that it acquired Coherex Medical for an undisclosed amount.

Salt Lake City-based Coherex makes the Wavecrest anti-stroke device, which is designed to occlude the heart’s left atrial appendage to prevent blood clots from forming that could cause stroke.

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