FDA approves dual-energy ablation tech from Johnson & Johnson
Johnson & Johnson MedTech has secured U.S. Food and Drug Administration (FDA) approval for its Dual-Energy ThermoCool SmartTouch SF (DE STSF) Platform that delivers both radiofrequency (RF) and pulsed field (PF) energy through a single catheter.
The DE STSF platform is integrated with Johnson & Johnson MedTech’s Carto technology, giving electrophysiologists access to the same advanced mapping and imaging capabilities that have been guiding ablation procedures for years.
“The FDA approval of the DE STSF Platform is another important milestone in what has been an incredible pace of innovation for our business,” Michael Bodner, chair of Johnson & Johnson MedTech’s electrophysiology & neurovascular business, said in a statement. “Our goal has always been to put the best possible technologies into physicians’ hands so they can treat increasingly complex cases with confidence. Following a successful introduction in Europe, we’re pleased to rapidly expand access to this technology in the U.S. and continue building on the momentum of one of the most active innovation periods in our history.”
“Electrophysiologists need technologies that support different anatomies, substrates, workflows and treatment goals,” added Dhanunjaya (DJ) Lakkireddy, MD, executive medical director at the Kansas City Heart Rhythm Institute. “The DE STSF gives electrophysiologists the choice to use RF or PF energy based on the needs of each procedure. Having both capabilities integrated in the Carto system can help us adapt our approach for more complex cases and plan procedures with greater confidence.”
With FDA approval now in place, Johnson & Johnson MedTech is in the process of initiating a phased commercial rollout. U.S. cardiologists are expected to start using this technology in the weeks ahead.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.