FDA Approves J&J’s Dual Energy THERMOCOOL SMARTTOUCH SF Platform

Johnson & Johnson has earned U.S. Food and Drug Administration (FDA) approval for the Dual Energy THERMOCOOL SMARTTOUCH SF Platform (DE STSF), an integrated catheter ablation solution that enables electrophysiologists to deliver both radiofrequency (RF) and pulsed field (PF) energy through a single catheter.ⁱ

“The FDA approval of the Dual Energy THERMOCOOL SMARTTOUCH SF Platform is another important milestone in what has been an incredible pace of innovation for our business,” Michael Bodner, company group chair, Electrophysiology & Neurovascular, MedTech, Johnson & Johnson, said in a news release issued today. “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.”

Built on the THERMOCOOL SMARTTOUCH SF Platform, which has extensive clinical validation and has treated over 1 million patients in the United States, the DE STSF Platform brings pulse field capability to a catheter physicians know and trust.ⁱ

The DE STSF platform is integrated with the CARTO ecosystem, including advanced mapping, imaging and PF Index guidance, helping physicians confidently deliver energy with precise contact force while supporting a predictable procedure and reproducible workflow. The dual energy capability gives physicians the versatility to use RF or PF energy based on patient anatomy and case complexity.ⁱ

“Electrophysiologists need technologies that support different anatomies, substrates, workflows and treatment goals,” said Dhanunjaya (DJ) Lakkireddy,* M.D., executive medical director at The Kansas City Heart Rhythm Institute. “The Dual Energy THERMOCOOL SMARTTOUCH SF Platform 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, the first U.S. procedures with the DE STSF Platform are expected to begin this summer as Johnson & Johnson initiates a phased commercial rollout.

Johnson & Johnson MedTech tackles the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, the company is addressing conditions with significant unmet needs, such as heart failure, coronary artery disease, stroke, and atrial fibrillation. Johnson & Johnson MedTech considers itself a global leader in heart recovery, circulatory restoration, and heart rhythm disorder treatment, as well as an emerging leader in neurovascular care, committed to addressing two of the leading causes of death worldwide: heart failure and stroke.

Johnson & Johnson’s expertise in Innovative Medicine and MedTech positions the company to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

* Dr. Lakkireddy serves as a consultant for Johnson & Johnson. Dr. Lakkireddy was not compensated for this authorship contribution.

Reference
ⁱ Mattias Duytschaever, Gediminas Račkauskas, Tom De Potter, et al. Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results EP Europace, Volume 26, Issue 5, May 2024, euae088, ttps://doi.org/10.1093/europace/euae088