Study will evaluate investigational Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter potential to deliver safe and effective radiofrequency (RF) and pulsed field ablation (PFA)
Irvine, CA December 14, 2023 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i 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 Careii and Dr. Andrea Natale, Executive Medical Director at Texas Cardiac Arrhythmia Institute, St. David’s Medical Center.iii
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.1 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.2 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.3 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.4
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.5,6 Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib.7 Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options and the importance of early treatment to avoid disease progression.8 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.9
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.
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.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the SmartPulse clinical trial first patient case. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Biosense Webster, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of healthcare products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at sec.gov, jnj.com or on request from Johnson & Johnson. None of Biosense Webster, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
i. Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
ii. Memorial Health University Physicians Heart Care entered into a clinical trial agreement with Biosense Webster, Inc. for its participation in the SmartPulse Study. Dr. David Newton serves as a study investigator and was not compensated for his contributions to this announcement.
iii. Texas Cardiac Arrhythmia Institute at St. David’s Medical Center entered into a clinical trial agreement with Biosense Webster, Inc. for its participation in the SmartPulse Study. Dr. Andrea Natale serves as a study investigator and was not compensated for his contributions to this announcement.
- Duytschaever M, De Potter T, Grimaldi M, et al. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol 2023;16(3). doi: 10.1161/CIRCEP.122.011780
- Nakagawa N, Farshchi S, Maffre J, et al. AB-452672-1 Effects of Electrode Contact Force on Lesion Size Produced by Pulsed Field Ablation. Heart Rhythm. 2023;20(5):S92.
- Diagnostic and Interventional Cardiology. Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter.
- Reddy VY, Neuzil P, Koruth JS, et al. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. JACC 2019;74(3)315-326.
- Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19. Erratum in: Int J Stroke. 2020 Jan 28;1747493020905964. PMID: 31955707.
- Kornej J, Börschel CS, Emelia J. Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century. Circulation Research. 2020 June;127(1):4-20. doi: 10.1161/CIRCRESAHA.120.316340
- Staerk, et al. 2018 Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. BMJ 2018;361:k1453 doi: 10.1136/bmj.k1453
- Kuck KH, Lebedev DS, Mikhaylov EN, et al. Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST). Europace 2021;23(3)362-369. doi: 10.1093/europace/euaa298.
- Natale, A. Reddy VY, Monir G, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. Journal of the American College of Cardiology, 2014;64(7),647–656. doi: 10.1016/j.jacc.2014.04.072
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