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Korea Herald
5 days ago
- Health
- Korea Herald
Johnson & Johnson Launches VARIPULSE™ Platform across Asia-Pacific, Advancing Atrial Fibrillation Treatment
The VARIPULSE™ Platform is the first Pulsed Field Ablation (PFA) system fully integrated with the CARTO™ 3 electroanatomical mapping system, designed to drive efficiency, reproducibility, and procedural accuracy. 1,i,ii,iii,iv,v,vi,vii,viii,ix The VARIPULSE™ Platform is approved in Japan, Hong Kong, China, Australia, Taiwan and Korea. IRVINE, Calif., July 8, 2025 /PRNewswire/ -- Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced the launch of the VARIPULSE™ Platform in Asia-Pacific. The platform is used to perform catheter ablation procedures for atrial fibrillation (AFib), an irregular and often rapid heartbeat caused by extra, uncoordinated electrical signals in the atria. x AFib is associated with structural changes in the heart due to underlying conditions and lifestyle factors. x,xi It significantly increases the risk of stroke, heart failure, and mortality. The VARIPULSE™ Platform is the first PFA technology designed to streamline ablation and mapping through a single integrated workflow with the CARTO™ 3 System. This 3D electroanatomical cardiac mapping technology enables real-time visualization and supports precision, efficiency, reproducibility, and procedural accuracy for physicians treating patients with atrial fibrillation (AFib) xii. It enables safe and efficient i,ii,iii,iv,v,vi,vii, patient-centric therapy with minimal to no fluoroscopy exposurex iii,xiv,xv and is compatible with deep and/or conscious sedation. 2,xvi,xvii This innovation is backed by compelling clinical evidence. Both the inspIRE and admIRE clinical trials demonstrated strong safety and effectiveness of the VARIPULSE™ Platform: "The introduction of the VARIPULSE™ Platform in the Asia-Pacific region marks a significant advancement towards our goal of transforming atrial fibrillation care," stated Jing Li, Vice President, Electrophysiology & Neurovascular, Johnson & Johnson MedTech, Asia Pacific. "The adoption of the VARIPULSE™ Platform could demonstrate the unique value of integration with CARTO™ 3D to enhance efficiencies in the workflow of AFib treatment and improve patient outcomes." Atrial Fibrillation affects over 16 million people in Asia-Pacific xxi. Symptoms and clinical consequences of AFib disrupt patient's quality of life. The most common symptoms are heart palpitations, fatigue, shortness of breath, chest pain, and dizziness xxii. As a progressive condition, early intervention is critical to reducing the risk of stroke, heart failure, and cardiovascular mortality xxiii. Unlike traditional ablation methods that use heat or cold, PFA uses short bursts of energy to affect heart tissue, potentially reducing the risk of damage to surrounding tissue such as the esophagus, pulmonary veins, and phrenic nerve. "PFA, as a new type of energy, has the potential to further enhance the safety and efficacy of catheter ablation treatment, which is desirable for patients" said Dr. Yasuo Okumura 7, Professor and Department Head, Vice Hospital Director, Nihon University School of Medicine, Itabashi Hospital, Tokyo, Japan. "PFA is a relatively new medical technology, and therefore it is important to continue to assess its effectiveness and efficacy in Asia while ensuring proper use. But so far, we know that the integration of PFA technology with 3D mapping enables physicians to review their procedure in detail, and this contributes to quality of healthcare for patients." About the VARIPULSE™ Platform The VARIPULSE™ Platform is Johnson & Johnson MedTech's Pulsed Field ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Software. The Platform is now approved for use in the United States, Europe, Asia Pacific, and Canada. Cardiovascular Solutions from Johnson & Johnson MedTech Across Johnson & Johnson, we are tackling 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 we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at Follow us at @JNJMedTech and on LinkedIn. Biosense Webster, Inc. is a Johnson & Johnson MedTech company. 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 VARIPULSE™ Platform. The reader is cautioned not to rely on these forward-looking statements. 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 Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; 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 health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, 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 or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. © Johnson & Johnson and its affiliates 2025. All rights reserved. M_US_ELP_NAVI_403012
Malaysian Reserve
5 days ago
- Business
- Malaysian Reserve
Johnson & Johnson Launches VARIPULSE™ Platform across Asia-Pacific, Advancing Atrial Fibrillation Treatment
The VARIPULSE™ Platform is the first Pulsed Field Ablation (PFA) system fully integrated with the CARTO™ 3 electroanatomical mapping system, designed to drive efficiency, reproducibility, and procedural accuracy.1,i,ii,iii,iv,v,vi,vii,viii,ix The VARIPULSE™ Platform is approved in Japan, Hong Kong, China, Australia, Taiwan and Korea. IRVINE, Calif., July 8, 2025 /PRNewswire/ — Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced the launch of the VARIPULSE™ Platform in Asia-Pacific. The platform is used to perform catheter ablation procedures for atrial fibrillation (AFib), an irregular and often rapid heartbeat caused by extra, uncoordinated electrical signals in the atria.x AFib is associated with structural changes in the heart due to underlying conditions and lifestyle factors.x,xi It significantly increases the risk of stroke, heart failure, and mortality. The VARIPULSE™ Platform is the first PFA technology designed to streamline ablation and mapping through a single integrated workflow with the CARTO™ 3 System. This 3D electroanatomical cardiac mapping technology enables real-time visualization and supports precision, efficiency, reproducibility, and procedural accuracy for physicians treating patients with atrial fibrillation (AFib)xii. It enables safe and efficienti,ii,iii,iv,v,vi,vii, patient-centric therapy with minimal to no fluoroscopy exposurexiii,xiv,xv and is compatible with deep and/or conscious sedation.2,xvi,xvii This innovation is backed by compelling clinical evidence. Both the inspIRE and admIRE clinical trials demonstrated strong safety and effectiveness of the VARIPULSE™ Platform: In inspIRE, 80% of patients achieved freedom from recurrence with zero primary adverse In admIRE, results showed a 75% overall primary effectiveness success rate3, a 2.9% primary adverse event rate4,xix, 100% of patients achieved acute procedural success5, 43% had same-day discharge, and 25% of procedures were performed without fluoroscopy6. In the ongoing VARIPURE registry, which included first-time users, there were no serious adverse events and no complications linked to the platform, including zero neurovascular events or coronary spasmsxx. 'The introduction of the VARIPULSE™ Platform in the Asia-Pacific region marks a significant advancement towards our goal of transforming atrial fibrillation care,' stated Jing Li, Vice President, Electrophysiology & Neurovascular, Johnson & Johnson MedTech, Asia Pacific. 'The adoption of the VARIPULSE™ Platform could demonstrate the unique value of integration with CARTO™ 3D to enhance efficiencies in the workflow of AFib treatment and improve patient outcomes.' Atrial Fibrillation affects over 16 million people in Asia-Pacificxxi. Symptoms and clinical consequences of AFib disrupt patient's quality of life. The most common symptoms are heart palpitations, fatigue, shortness of breath, chest pain, and dizzinessxxii. As a progressive condition, early intervention is critical to reducing the risk of stroke, heart failure, and cardiovascular mortalityxxiii. Unlike traditional ablation methods that use heat or cold, PFA uses short bursts of energy to affect heart tissue, potentially reducing the risk of damage to surrounding tissue such as the esophagus, pulmonary veins, and phrenic nerve. 'PFA, as a new type of energy, has the potential to further enhance the safety and efficacy of catheter ablation treatment, which is desirable for patients' said Dr. Yasuo Okumura7, Professor and Department Head, Vice Hospital Director, Nihon University School of Medicine, Itabashi Hospital, Tokyo, Japan. 'PFA is a relatively new medical technology, and therefore it is important to continue to assess its effectiveness and efficacy in Asia while ensuring proper use. But so far, we know that the integration of PFA technology with 3D mapping enables physicians to review their procedure in detail, and this contributes to quality of healthcare for patients.' About the VARIPULSE™ PlatformThe VARIPULSE™ Platform is Johnson & Johnson MedTech's Pulsed Field ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Software. The Platform is now approved for use in the United States, Europe, Asia Pacific, and Canada. Cardiovascular Solutions from Johnson & Johnson MedTechAcross Johnson & Johnson, we are tackling 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 we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit About Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at Follow us at @JNJMedTech and on LinkedIn. Biosense Webster, Inc. is a Johnson & Johnson MedTech company. 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 VARIPULSE™ Platform. The reader is cautioned not to rely on these forward-looking statements. 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 Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; 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 health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, 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 or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. © Johnson & Johnson and its affiliates 2025. All rights reserved. M_US_ELP_NAVI_403012 ________________________________________ 1 When compared to procedures that did not use navigation systems. 2 Based on a subset of 29 deep sedation patients from the inspIRE study and 60 patients in inspIRE study. Procedures completed under sedation vs general anesthesia had comparable safety rates and procedure times, demonstrating safety and procedural efficiency. 3 Primary effectiveness was defined as 12-month freedom from documented (symptomatic or asymptomatic) atrial tachyarrhythmia (atrial fibrillation [AF]/atrial tachycardia [AT]/atrial flutter [AF]) episodes of ≥30 seconds duration based on rhythm monitoring during the post-blanking evaluation period (day 91-365), as well as freedom from other failure modes: failure to achieve entrance block in all PVs; >1 repeat ablation for atrial tachyarrhythmia during the 3-month blanking period or any repeat ablation during the evaluation period; use of a nonstudy catheter to treat the PVs and/or to ablate left atrial non-PV AF targets during the index procedure or to perform a repeat procedure during the 3-month blanking period; taking new or previously failed Class I/III AADs at greater doses during the evaluation period; continuous AF/AT/AFL of unknown origin during the evaluation period; or direct-current cardioversion during the evaluation period for AF/AT/AFL recurrences. The protocol defined performance goal is 50%. 4 Primary adverse events included device- or procedure- related death, major vascular access complications or bleeding, myocardial infarction, pericarditis, heart block, permanent phrenic nerve paralysis, stroke, thromboembolism, transient ischemic attack, pulmonary edema, and vagal nerve injury/gastroparesis within 7 days of the index ablation procedure. PAEs also included cardiac tamponade/perforation occurring up to 30 days post-procedure, atrioesophageal fistula occurring up to 90 days postprocedure, and PV stenosis occurring anytime during the 12-month follow-up period. The protocol-defined performance goal was 12%. 5 Acute procedural success was defined as the percent of participants with electrical isolation of all PVs with confirmed entrance block at the end of the procedure (n=255). 6 Visualization performed with ICE and the CARTO™ 3 System. 7 Dr. Okumura serves as a consultant for Johnson & Johnson but was not compensated for this announcement ________________________________________ i 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):e011780. doi:10.1161/CIRCEP.122.011780 pg 4 ii Reddy VY, Calkins H, Mansour M, Wazni O, Di Biase L, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Athill C, Hussein A, Whalen P, Melby D, Natale A; AdmIRE Trial Investigators. Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial. Circulation. 2024 Oct 8 pg 8 iii Anter, E., Mansour, M., Nair, D.G. et al. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med 30, 2303–2310 (2024). pg 2 iv Reddy VY, Lehmann JW, Gerstenfeld EP, Mugglin AS, Schneider CW, Achyutha AB, Mansour M. A randomized controlled trial of pulsed field ablation versus standard-of-care ablation for paroxysmal atrial fibrillation: The ADVENT trial rationale and design. Heart Rhythm O2. 2023 Mar 8;4(5):317-328. doi: 10.1016/ PMID: 37323994; PMCID: PMC10264259. Pg 6 v VOLT CE Mark Study: Long-term safety and effectiveness of de novo PVI intreating AF. pg 3 vi Scherr D, Turagam MK, Maury P, Blaauw Y, van der Voort P, Neuzil P, et al. Repeat procedures after pulsed field ablation for atrial fibrillation: MANIFEST-REDO study. Europace. 2025;2025(1):euaf012. doi:10.1093/europace/euaf012. Pg 4 results section vii Seemala SKR, Musikantow DR, Perdomo C, Malyshev Y, Ambesh P, Saleem M, et al. Pulsed field ablation (PFA) to treat atrial fibrillation and related arrhythmias: one-year outcomes of the VIRTUE trial. Poster PO-FP-006. Pg 1 viii Fink T, Sciacca V, Bannmann K, et al. First experience using a novel variable loop catheter for mapping and pulsed field ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2025 May;48(5):471-479. doi:10.1111/pace.15177. Epub 2025 Mar 28. PMID:40153431; PMCID:PMC12063197 ix Fink T, Sciacca V, Bannmann K, et al. First experience using a novel variable loop catheter for mapping and pulsed field ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2025 Mar 28. doi:10.1111/pace.15177. Epub ahead of print. PMID: 40153431. x Laizzo PA. Handbook of Cardiac Anatomy, Physiology, and Devices. 2015. Springer Science+Business Media. LLC: Switzerland xi Staerk L, Sherer JA, Ko D, Benjamin EJ, Helm RH. Atrial Fibrillation: Epidemiology, Pathophysiology, and Clinical Outcomes. Circ Res. 2017;120(9):1501-1517 xii Di Biase L, Zou F, Lin AN, et al. Feasibility of Three-Dimensional Artificial Intelligence Algorithm Integration with Intracardiac Echocardiography for Left Atrial Imaging During Atrial Fibrillation Catheter Ablation. Europace. 2023 Aug 2;25(9):euad211. xiii Debreceni D, Janosi K, Bocz B, et al. (2023). Zero fluoroscopy catheter ablation for atrial fibrillation: a systematic review and meta-analysis. Front Cardiovasc Med;10:1178783. doi: 10.3389/fcvm.2023.1178783 xiv Rajendra A, Hunter TD, Morales GX, et al. (2023). Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy. J Interv Card Electrophysiol;66(2):381-388. doi: 10.1007/s10840-022-01332-8. xv Tahin T, Riba A, Nemeth B, et al. (2021). Implementation of a zero fluoroscopic workflow using a simplified intracardiac echocardiography guided method for catheter ablation of atrial fibrillation, including repeat procedures. BMC Cardiovasc Disord;21(1):407. doi: 10.1186/s12872-021-02219-8. xvi Grimaldi M, Quadrini F, Caporusso N, et al. Deep sedation protocol during atrial fibrillation ablation using a novel variable-loop biphasic pulsed field ablation catheter. Europace. 2023;25(9):euad222. doi:10.1093/europace/euad222. PMID: 37470452; PMCID: PMC10434733. xvii De Potter T, Grimaldi M, Duytschaever M, Anic A, Vijgen J, Neuzil P, Van Herendael H, Verma A, Skanes A, Scherr D, Pürerfellner H, Rackauskas G, Jais P, Reddy VY, et al; inspIRE Trial Investigators. Predictors of success for pulmonary vein isolation with pulsed-field ablation using a variable-loop catheter with 3D mapping integration: complete 12-month outcomes from inspIRE. Circ Arrhythm Electrophysiol. 2024;17(5):e012667. doi:10.1161/CIRCEP.123.012667. Epub 2024 Apr 24. PMID: 38655693; PMCID: PMC11111320. xviii Reddy V, Grimaldi M, Duytschaever M, Anic A. Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE [abstract]. In: AF Symposium.; February 2-4; Boston. xix Reddy V, Calkins H, Mansour M, et al. Pulsed field ablation to treat paroxysmal atrial fibrillation: safety and effectiveness in the admIRE pivotal trial. Circulation. Published online September 11, 2024. doi: 10.1161/CIRCULATIONAHA.124.070333. xx Bessière F, Kronborg MB, Sommer P, et al. Evaluating Safety Profile and Learning Curve With a Pulsed Field Ablation Variable Loop Circular Catheter in Procedures for AF: Observations From a Prospective, Multicenter, Postmarket Clinical Trial. Presented at HRS 2025; April 27, 2025; San Diego, CA. xxi Global Burden of Disease Collaborative Network (2017) Global Burden of Disease Study 2017 (GBD 2017) Results. Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2017. Accessed 2019-07-16. Available from xxii American Heart Association . (2024, August 12). What are the symptoms of atrial fibrillation?. xxiii Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines [published correction appears in Circulation. 2024 Jan 2;149(1):e167]. Circulation. 2024;149(1):e1-e156. doi:10.1161/CIR.0000000000001193 Media contacts:Carlos Taveras Ctaveras@ FarleyEfarley1@ View original content:
Yahoo
21-05-2025
- Health
- Yahoo
Johnson & Johnson MedTech Launches SOUNDSTAR CRYSTAL™ in the US, Redefining Image Clarity in 2D Intracardiac Imaging
New ultrasound catheter delivers superior image quality,i,ii peak maneuverability and seamless CARTO™ 3 System integrationi, giving physicians improved visualizationii for added confidence during cardiac ablation procedures IRVINE, Calif., May 21, 2025 /PRNewswire/ -- Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, announced the U.S. launch of the SOUNDSTAR CRYSTAL™ Ultrasound Catheter for intracardiac echocardiography (ICE) imaging in cardiac ablation procedures. The device provides clearer, enhanced image quality compared to other ICE cathetersii, representing an advanced 2D ICE catheter. Integrated with CARTO™ 3 Mapping Systemi, including the CARTOSOUND™ FAM module for enhanced mapping capabilities powered by AI1,iii, SOUNDSTAR CRYSTAL™ provides an efficient workflowi. CARTOSOUND™ FAM enables automatic generation of the left atrial anatomy by a novel artificial intelligence algorithm using images collected from a rotation of the ultrasound catheter in the right atrium, simplifying the integrated workflowi for electrophysiologists performing cardiac ablation procedures for patients1. "We are proud to advance our legacy in integrated ultrasound catheters with this latest innovation that equips electrophysiologists with the tools they need to promote patient safetyii and drive effectiveiv results," said Jasmina Brooks, President, Electrophysiology, Johnson & Johnson MedTech. "The superior image qualityi,ii , improved catheter maneuverabilityii and stability of the SOUNDSTAR CRYSTAL™ Ultrasound Catheter, along with seamless CARTO™ 3 System integrationi can help enable a zero fluoroscopy workflowiv,v,†,2,3,4,vi, enhancing procedure effectiveness and safety for both healthcare professionals and patients they treat." ICE is broadly used in catheter ablation procedures to visualize the heart in high resolution to monitor catheter-tissue contact and ablation in real-time and quickly detect procedural complications. When real-time imaging is integrated with a 3D electroanatomical mapping system, such as the CARTO™ 3 System, ICE can help reconstruct cardiac anatomy and enable zero-fluoroscopy proceduresv†,2,3,4. ICE-guided electrophysiology procedures can be performed under conscious sedation, without requiring esophageal intubation and additional anesthesiavii,5. "During the cases I performed with the SOUNDSTAR CRYSTAL™ Ultrasound Catheter, I was impressed by the clear visualization, tissue definition and enhanced far field imagingi, and full integration with other platforms. Integration with the CARTO™ 3 System provides clear, high-resolution imagesi,viii which simplify the anatomical mapping processix and procedure workflowv," said Amin Al-Ahmad, MDx, St. David's HealthCare, Austin, TX. The SOUNDSTAR CRYSTAL™ Ultrasound Catheter is the latest addition to a comprehensive portfolio of ultrasound solutions at Johnson & Johnson MedTech. The company recently brought forward the NUVISION™ Catheter, which harnesses advanced 4D imaging to assist physicians performing cardiac procedures, such as Left Atrial Appendage Closure (LAAC). Cardiac arrhythmias are a growing epidemic. AFib alone is the most common type of cardiac arrhythmia and impacts more than 50 million people worldwide, and 8 million people in the U.S6. AFib is a progressive disease, and if left untreated can get worse over time or lead to other serious complications like heart disease or stroke7,8. Catheter ablation is a safe and effective procedure to restore the heart's incorrect electrical signals, which causes an abnormal heart rhythm9. About SOUNDSTAR CRYSTAL™ SOUNDSTAR CRYSTAL™ is an ultrasound catheter that features an 88-element phased linear array to deliver outstanding image quality and detailed visualization of intricate anatomical structures inside the hearti. SOUNDSTAR CRYSTAL™ is integrated with the CARTO™ 3 System for a cohesive and efficient workflow during catheter ablation procedures. The catheter also is designed with optimal balance of stiffness and flexibility, ensuring precision in maneuverabilityi. Cardiovascular Solutions from Johnson & Johnson MedTechAcross Johnson & Johnson, we are tackling 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 we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit and connect on LinkedIn and X, formerly Twitter. About Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in surgery, orthopaedics, vision and cardiovascular solutions at Follow us at @JNJMedTech and on LinkedIn. Biosense Webster, Inc. is a Johnson & Johnson MedTech company. Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding SOUNDSTAR CRYSTAL™. 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 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 most recent Annual Report on Form 10-K, 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 , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or or on request from Johnson & Johnson. © Johnson & Johnson and its affiliates 2025. All rights reserved. US_ELP_ULTR_399314 i Based on Siemens' internal report CRF data responses as of 8/9/2024. CRF Data PN When compared to [ACUSON AcuNav™ Ultrasound Catheter] [SOUNDSTAR™ Ultrasound Catheter]iii CARTOSOUND™ FAM Module uses Deep Learning, which is a subset of AIiv Safety profile refers to complication and primary adverse event rates†Efficacy profile refers to acute success (pulmonary vein isolation) and long-term success.v Based on a survey of 31 Johnson & Johnson and its affiliates' portfolio of products with FDA approved/cleared instructions for use to support fluoro alternative workflows when used with the CARTO™ 3 System include the following: THERMOCOOL SMARTTOUCH™ SF Catheter, THERMOCOOL SMARTTOUCH™ Catheter, CARTO™ VIZIGO™ Bi-Directional Guiding Sheath, PENTARAY™ NAV ECO High Density Mapping Catheter, OCTARAY™ Mapping Catheter with TRUEref™ Technology, OPTRELL™ Mapping Catheter with TRUEref™ Technology, DECANAV™ Mapping Catheters, and Webster™ CS Based on a meta analysis of ICE applications in EPviii When compared to SOUNDSTAR™ Catheterix Based on 96 surveys, by 31 EPs with an average score of 5.0 or higher on 7-point Likert scale with 5=Satisfied 6/7=Completely Satisfiedx Dr. Al-Ahmad serves as a consultant for Johnson & Johnson but was not compensated for this announcement. 1 CARTOSOUND™ FAM Module Instructions for Use. UG_5462-018H P02. November 2023.2 Debreceni D, Janosi K, Bocz B, et al. (2023). Zero fluoroscopy catheter ablation for atrial fibrillation: a systematic review and meta-analysis. Front Cardiovasc Med;10:1178783. doi: 10.3389/fcvm.2023.1178783.3 Rajendra A, Hunter TD, Morales GX, et al. (2023). Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy. J Interv Card Electrophysiol;66(2):381-388. doi: 10.1007/s10840-022-01332-8.4 Tahin T, Riba A, Nemeth B, et al. (2021). Implementation of a zero fluoroscopic workflow using a simplified intracardiac echocardiography guided method for catheter ablation of atrial fibrillation, including repeat procedures. BMC Cardiovasc Disord;21(1):407. doi: 10.1186/s12872-021-02219-8.5 Tong Hu, Tongshuai Chen, Kellina Maduray, Wenqiang Han, Jingquan Zhong. Intracardiac Echocardiography: An Invaluable Tool in Electrophysiological Interventions for Atrial Fibrillation and Supraventricular Tachycardia. Rev. Cardiovasc. Med. 2024, 25(6), 191. Mensah, G, Fuster, V, Murray, C. et al. Global Burden of Cardiovascular Diseases and Risks, 1990-2022. J Am Coll Cardiol. 2023 Dec, 82 (25) 2350–2473.7 Calkins, H., et al (2017). 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart rhythm, 14(10), e275–e444.8 Odutayo, A. et al (2016). Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ (Clinical research ed.), 354, i4482.9 Natale, A. et al (2014). 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, 64(7), 647–656. Media Contacts: Erin Farleyefarley1@ Majo EcheverriaMechever@ Investor Relations:Tracy MenkowskiInvestor-relations@ View original content to download multimedia: SOURCE Johnson & Johnson MedTech
Yahoo
25-04-2025
- Business
- Yahoo
Johnson & Johnson MedTech Presents 3-Month Data from Omny-IRE Clinical Trial at 2025 Heart Rhythm Society Annual Meeting
Omny-IRE data demonstrated the investigational OMNYPULSE™ Platform achieved 100% acute success and 84.5% pulmonary vein isolation (PVI) durability at three months, with promising safety outcomes1 Additional data presented from VARIPURE registry2 and Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter3 pre-clinical study underscore safety and real-world efficiency across Johnson & Johnson MedTech's expanding pulsed field ablation portfolio IRVINE, Calif., April 25, 2025 /PRNewswire/ -- Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced positive, initial 3-month results from the Omny-IRE study, evaluating the investigational OMNYPULSE™ Platform in patients with paroxysmal atrial fibrillation (PAF). The data, unveiled as a late breaking presentation at the 2025 Heart Rhythm Society (HRS) annual meeting, demonstrated the potential for both high acute effectivenessi and a promising safety profile: 100% acute PVI with durable isolation in 84.5% of pulmonary veins at 3-month remapping and a 3.0% primary adverse event rate, with only 0.7% being potentially catheter related.1 The data has been simultaneously published in JACC Clin Electrophysiology. Omny-IRE is a 12-month prospective, multi-center, non-randomized clinical trial that evaluates the safety and effectiveness of the OMNYPULSE™ Platform for the mapping and treatment of symptomatic PAF during standard ablation The OMNYPULSE™ Platform consists of the OMNYPULSE™ Catheter, a novel focal pulsed field ablation (PFA) catheter, and the TRUPULSE™ Generator, and is fully integrated with the CARTO™ 3 System. The OMNYPULSE™ Catheter is the first large-tip, 12 mm focal catheter with contact force sensing and a TRUEref™ reference electrode to reduce the impact of far-field unipolar signals. The TRUPULSE™ Generator provides a bipolar, biphasic pulse application to the catheter's twelve electrodes. With the CARTO™ 3 System software used in the study, clinicians were able to obtain a Pulsed Field (PF) Index value for each ablation, which is a calculation using the real-time contact force feedback combined with the number of pulsed field applications.5 As an integrated platform, OMNYPULSE™ brings together mapping precision, energy delivery, and real-time feedback into a single ecosystem—streamlining workflows and helping electrophysiologists deliver more consistent outcomes.1 "The 3-month data provide encouraging early evidence of the OMNYPULSE™ Platform," said Mattias Duytschaever M.D., Ph.D., Department of Cardiology, Electrophysiology Section, AZ Sint-Jan Hospital, Brugge, "What's most compelling is the combination of 100% acute and strong remap success1 with a low rate of safety events. These results reinforce the potential of OMNYPULSE and its integration with the CARTO™ 3 System to deliver reproducible, durable outcomes for patients with paroxysmal AFib." In addition, data from the VARIPURE study are being shared at the HRS Annual Meeting, evaluating the real-world safety and operator learning curve associated with the use of the VARIPULSE™ Platform PVI procedures for atrial fibrillation. Conducted across 13 European sites, the prospective, post-market study included 247 patients and 40 operators with varying levels of experience, including first-time users. Notably, no serious adverse events were reported, and no complications were linked to the platform, including zero neurovascular events or coronary spasms. Among a subset of 115 patients treated by operators performing their first 10 VARIPULSE™ cases, results showed no measurable learning curve beyond a modest reduction in idle time between ablations, underscoring the efficiency and ease of adopting this innovative technology.2 VARIPURE is an ongoing registry, with over 600 patients enrolled to date. "The VARIPULSE™ Platform has both a strong safety profile and is highly accessible to new users, enabling safe and consistent outcomes from the very first case. As adoption of PFA expands, I believe VARIPULSE™ can play a key role in broadening access to safe and streamlined ablation procedures," said Francis Bessière M.D., Ph.D., Cardiac Electrophysiology Department, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon, Additional data presented at HRS by Dr. Hiroshi Nakagawa include new preclinical validation of a PF Index from the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter, leveraging data from lesions created in a swine beating heart model. The analysis confirmed that lesion depth, which is crucial for effective treatment, correlates strongly with the number of PFA pulses and contact force using a logarithmic PF Index—accurately predicting lesion depth within ±1 mm in 92% of cases and ±1.5 mm in all cases. These findings reinforce the reliability of the pulse dosing protocol and underline the PF Index's value as a practical tool for guiding ablation. The index is specifically optimized to support durable lesion formation, offering physicians confidence in its outputs and enabling them to make informed, real-time decisions with a high degree of procedural predictability and clinical precision.3 These multiplatform findings advance the clinical and technical validation of Johnson & Johnson MedTech's PFA portfolio across focal, regional and dual energy catheter designs—each leveraging CARTO™ 3 System integration and real-time lesion feedback. These latest data are part of Johnson & Johnson MedTech's commitment to advancing understanding of PFA, including the recently announced 12-month results from the SmartfIRE clinical trial presented in March 2025. "Our PFA portfolio is built around what matters most to physicians—durability, control, safety and efficiency," said Jennifer Currin, Ph.D., Vice President, Scientific Affairs, Johnson & Johnson MedTech. "The Omny-IRE, VARIPURE, and Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter data demonstrate our commitment to delivering safe, effective, and reliable PFA tools." Additional information on Johnson & Johnson's data presented at HRS can be found here. About The OMNYPULSE™ Platform The investigational OMNYPULSE™ Platform uses pulsed electrical field energy to produce targeted intracardiac lesions for the treatment of atrial fibrillation. The platform includes the TRUPULSE™ multichannel generator and multi-electrode OMNYPULSE™ Catheter used in conjunction with the CARTO™ 3 System with the VISITAG SURPOINT™ Module PF Index to provide electroanatomical maps, contact force sensing, PF Index values and catheter localization information for ablations for the treatment of paroxysmal atrial fibrillation. The OMNYPULSE™ Platform is not currently approved in any region of the world. About The Omny-IRE Study Omny-IRE is a pivotal, prospective, multi-center, non-randomized study in Europe and Canada to demonstrate the safety and effectiveness of Johnson & Johnson MedTech's OMNYPULSE™ Platform, the principal components of which are the OMNYPULSE™ Catheter and the TRUPULSE™ Generator. The study is evaluating the system for the treatment of symptomatic paroxysmal atrial fibrillation during standard electrophysiology mapping and ablation procedures while also evaluating the incidence of primary adverse events within seven days post-procedure. About the VARIPULSE™ PlatformThe VARIPULSE™ Platform consists of the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Software. The VARIPULSE Catheter is a variable-loop circular catheter (VLCC) used for pulsed field ablation (PFA) in atrial fibrillation treatment, particularly for pulmonary vein isolation, and allows for adjustment of the loop size to conform to different patient anatomies. About the Dual Energy THERMOCOOL SMARTTOUCH™ SF CatheterThe Dual Energy THERMOCOOL SMARTTOUCH™ SF Platform consists of the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter – an irrigated, contact-force sensing catheter – and the TRUPULSE™ Generator, providing both RF and PF energy to the catheter through the toggling of the two energy sources on the generator monitor.6 The catheter and the generator are fully integrated with the CARTO™ 3 System, enabling advanced 3D mapping visualization with integrated ultrasound during ablation procedures.v The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter is the first dual energy PFA / RF ablation catheter integrated with a PF and RF tag index. The Catheter received European CE Mark in December 2024; it is investigational in the United States. Cardiovascular Solutions from Johnson & Johnson MedTech Across Johnson & Johnson, we are tackling 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 we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circular restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit and connect on LinkedIn and X, formerly Twitter. About Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at Biosense Webster, Inc. is part of Johnson & Johnson MedTech. Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the OMNYPULSE™ Platform clinical trials, VARIPULSE™ Platform, CARTO™ 3 System, and Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter. 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 most recent Annual Report on Form 10-K, 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 or on request from Johnson & Johnson. Neither Biosense Webster, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. © Johnson & Johnson and its affiliates 2025. All rights reserved. US_ELP_NAVI_399689i Acute efficacy was defined to be adenosine/isoproterenol-proof PVI at the end of the procedure and had a 90% performance goal. ii 12-month results to be published once available (or upon study completion) iii AZ Sint-Jan Hospital entered into a clinical trial agreement with Biosense Webster, Inc., part of Johnson & Johnson MedTech for their participation in the Omny-IRE Study. Dr. Duytschaever served as a study coinvestigator. Dr. Duytschaever serves as a consultant for Johnson & Johnson but was not compensated for this announcement. iv VARIPURE (VARIPULSE™ Catheter data exchange Platform powered by SECURE) is a SECURE substudy. Hospices Civils de Lyon - Bron entered into a clinical trial agreement with Biosense Webster, Inc., part of Johnson & Johnson MedTech for their participation in the SECURE Study. Dr. Bessière served as a site principal investigator. Dr. Bessière serves as a consultant for Johnson & Johnson but was not compensated for this announcement. v Results reported after 9 months for patients with paroxysmal AFib who had failed 1 antiarrhythmic medication in randomized trial. 1 Duytschaever M, Grimaldi M, De Potter T, et al. Safety, efficacy and PVI durability of a contact force-sensing large-tip focal pulsed field ablation catheter integrated with 3D mapping to treat paroxysmal atrial fibrillation: first-in-human Omny-IRE 3-month results. Presented at HRS 2025; April 25, 2025; San Diego, CA. 2 Bessière F, Kronborg MB, Sommer P, et al. Evaluating Safety Profile and Learning Curve With a Pulsed Field Ablation Variable Loop Circular Catheter in Procedures for AF: Observations From a Prospective, Multicenter, Postmarket Clinical Trial. Presented at HRS 2025; April 27, 2025; San Diego, CA. 3 Nakagawa H, Farshchi S, Maffre J, et al. Predicting Lesion Depth During Pulsed Field Ablation: Prospective Validation of a Novel Ablation Index Based on Contact Force and Number of Applications in a Swine Beating Heart Model. Presented at HRS 2025; April 24, 2025; San Diego, CA. 4 A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator (Omny-IRE). Accessed April 8, 2025. 5 Biosense Webster. (2023). OMNYPULSE™ Bi-Directional Catheter IFU. 6 De Potter T, Scherr D, Pürerfellner H, et al. Safety, effectiveness, and healthcare benefits of a dual energy focal ablation technology to treat paroxysmal atrial fibrillation: SmartfIRE 12-month results. Presented at EHRA 2025; March 31, 2025; Vienna, Austria. Pending formal publication. Media Contacts:Lindsey Diaz-MacInnisldiazmac@ Kristina KauffmanKkauffm4@ Investor Relations:Tracy Menkowskiinvestor-relations@ View original content to download multimedia: SOURCE Johnson & Johnson MedTech Sign in to access your portfolio
