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J&J wins FDA approval for ablation catheter

October 7, 2020 By Chris Newmarker

Biosense Webster Johnson & Johnson J&J  Thermocool SmartTouch SF ablation catheter
The Thermocool SmartTouch SF ablation catheter [Image courtesy of J&J’s Biosense Webster]

Johnson & Johnson (NYSE:JNJ) recently announced that its Biosense Webster business has secured FDA approval for its Thermocool SmartTouch SF ablation catheter.

The Thermocool SmartTouch received approval for the treatment of persistent atrial fibrillation, J&J announced yesterday.

The approval came after results from the 381-patient, prospective, multi-center Precept study that found that 80% of persistent AF patients experienced clinical success at 15 months after ablation therapy using the Thermocool SmartTouch SF catheter with Carto Visitag module.

The study also found people suffering from AF experienced a clinically meaningful improvement in their quality of life, with a significant reduction in healthcare resource utilization post-ablation.

“Every patient and every arrhythmia are unique,” said Dr. Francis Marchlinski, director of electrophysiology at the University of Pennsylvania Health System. “This approval and the Precept data provide evidence to support a tailored approach using the Carto 3 System and Thermocool SmartTouch SF Catheter to treat persistent AF patients, who are more at risk for stroke and other complications from their AF.”

Uri Yaron, worldwide president of Biosense Webster, added that persistent AF patients face a higher risk of complications such as stroke, heart failure, and death. “This approval and data from the Precept study help to further our commitment to advancing AF treatment, providing electrophysiologists with state-of-the-art options for their patients.”

Filed Under: Catheters Tagged With: Biosense Webster, Johnson & Johnson

About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

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