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Biosense Webster Begins Enrollment of SmartPulse Study in the U.S. to Evaluate RF and PFA Dual Energy Catheter to Treat Atrial Fibrillation
Irvine, CA December 14, 2023 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,1 announced the first patient cases with the investigational Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter took place as part of the SmartPulse pivotal study for treatment of paroxysmal atrial fibrillation (AFib). The first procedures were performed by Dr. David Newton, Clinical Cardiac Electrophysiologist at Memorial Health University Physicians Heart Care2 and Dr. Andrea Natale, Executive Medical Director at Texas Cardiac Arrhythmia Institute, St. David’s Medical Center.3
The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter (Dual Energy STSF) is an investigational focal, contact force sensing catheter able to deliver both RF and PFA energy. The investigational TRUPULSE™ Generator provides both the RF energy and PFA energy to the catheter through the toggling of the two energy sources on the generator monitor.i The catheter and the generator are integrated with the CARTO™ 3 Mapping System to enable accurate 3D visualization with minimal fluoroscopy for electrophysiologists (EPs) and their staff. Additionally, this platform integrates parameters such as contact force measurement and ablation indexes for RF and PFA which have proven in preclinical studies to be critical for lesion creation.ii With this differentiated system, Biosense Webster is giving EPs the tools and information they need in real-time.
SmartPulse is a prospective, single arm, multi-center, clinical evaluation that will enroll approximately 250 patients with paroxysmal AFib in the United States to evaluate the safety and effectiveness of the Dual Energy STSF Catheter.
“The SmartPulse pivotal trial will allow us to learn more about the promise of PFA in paroxysmal AFib. The Dual Energy STSF Catheter is an exciting innovation because it allows customization of treatment by switching between radiofrequency and pulsed field energy,” said Dr. Andrea Natale, Executive Medical Director at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, who conducted one of the first patient cases.iii “The ability to deliver both types of energy via one catheter simplifies the workflow for ablation procedures, while integration with the CARTO™ 3 Mapping System enables real-time catheter visualization and feedback on contact force measurements and ablation indexes – important factors for durable lesion formation.”
In July 2023, Biosense Webster announced it completed enrollment of the SmartfIRE study that is evaluating the safety and efficacy of the Dual Energy STSF Catheter for the treatment of drug refractory symptomatic paroxysmal AFib in Europe.
“The THERMOCOOL SMARTTOUCH™ SF Catheter is the most commonly used ablation catheter globally.iii By bringing the benefits of RF and PFA to a single catheter that EPs are accustomed to, we are giving physicians control of their preferred energy source and offering a point-by-point workflow that many prefer,” said Jasmina Brooks, President, Biosense Webster, Inc. “SmartPulse is the latest study in a robust global clinical trial program for the Biosense Webster investigational PFA portfolio aimed at ensuring our differentiated platform gives EPs the tools and information they need in real-time to deliver the best possible patient care.”
Catheter ablation is a minimally invasive procedure performed by an EP to treat heart rhythm disorders, including AFib, by interrupting irregular electrical pathways in the heart by delivering either heat (RF ablation) or cold (cryoablation). PFA represents a new approach to treating AFib, utilizing a controlled electric field to selectively ablate cardiac tissue that causes the irregular heartbeat through a process called irreversible electroporation (IRE). Because the pulsed field energy is minimally thermal, IRE offers the potential to reduce the risk of damage to surrounding tissues including esophageal, pulmonary vein, and phrenic nerve injury.iv
AFib is the most common type of cardiac arrhythmia and affects more than 6 million people in the United States and nearly 38 million people worldwide.v,vi Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib.vii Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options and the importance of early treatment to avoid disease progression.viii Catheter ablation is a safe and effective procedure when drugs don’t work to help restore the heart’s incorrect electrical signals, which causes an abnormal heart rhythm.ix
The Dual Energy STSF Catheter and the TRUPULSE™ Generator are under development and not available for sale in any region of the world. To learn more about the SmartPulse study and our approach to PFA, visit here.
About SmartPulse
SmartPulse is a prospective, single arm, multi-center, clinical evaluation that will enroll approximately 250 patients in the United States to demonstrate the safety and effectiveness of the Biosense Webster dual energy pulsed field (PFA) / radiofrequency (RF) ablation system. The principal components of the ablation system to be evaluated in this investigation are the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter and the TRUPULSE™ Generator. The study will evaluate the safety and effectiveness of the ablation when used for isolation of atrial pulmonary veins in treatment of subjects with paroxysmal AFib.
About Biosense Webster
Biosense Webster, Inc. is the global market leader in the science and technology behind the diagnosis and treatment of cardiac arrhythmias. Part of Johnson & Johnson MedTech, the specialized medical technology company is headquartered in Irvine, California, and works across the world to advance the tools and solutions that help electrophysiologists identify, treat, and deliver care. Learn more at www.biosensewebster.com and connect on LinkedIn and X, formerly Twitter.
About Johnson & Johnson MedTechi
At Johnson & Johnson MedTech,i we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.
