Nippon Medical School

Integrated with Varipulse Catheter, Trupulse Generator, and CARTO 3D cardiac mapping system, Varipulse is said to be the first and only PFA system approved in Japan for the treatment of symptomatic drug refractory recurrent paroxysmal AFib Varipulse Platform comprises Varipulse Catheter, Trupulse Generator, and Carto 3D cardiac mapping system. (Credit: PRNewswire/ Biosense Webster) Biosense Webster, a part of Johnson & Johnson MedTech, has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for its Varipulse pulsed field ablation (PFA) platform. The PFA platform is intended for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AFib). It comprises a Varipulse Catheter, a variable-loop multielectrode catheter; Trupulse Generator, a multichannel PFA generator; and CARTO 3 System, a 3D cardiac mapping system. Varipulse platform is said to be the first and only Carto-integrated PFA system that enables an intuitive and reproducible workflow with real-time visualisation and feedback mechanisms. Biosense Webster president Jasmina Brooks said: “At Biosense Webster, we are working to deliver a differentiated PFA portfolio integrated with 3D cardiac mapping to address the real-world, unmet needs of electrophysiologists and the patients they treat. “Today, we celebrate this milestone approval of the Varipulse Platform, the first and only PFA system approved in Japan. “We are excited to continue to advance PFA clinical studies globally and look forward to the positive impact this innovation will deliver to patients everywhere.” Catheter ablation is a minimally invasive procedure to treat heart rhythm disorders, including AFib, by delivering heat (radiofrequency ablation) or cold (cryoablation). PFA represents a new approach to treating AFib, which uses a controlled electric field to selectively ablate cardiac tissue that causes irregularity in the heartbeat. It leverages the irreversible electroporation (IRE) process to deliver the electric field, which reduces the risk of damage to surrounding tissues. The Varipulse PFA platform has been evaluated in the inspIRE clinical trial in Europe. Early results from the study showed a one-year clinical success of 78.9%, defined as freedom from documented symptomatic atrial arrhythmia recurrence. The clinical trial also showed a notable safety profile, with no primary adverse events reported. The platform’s unique pulse sequence, catheter design, and CARTO 3 System integration enabled a simplified workflow and effective procedures, said the medical device company. Nippon Medical School department of cardiovascular medicine professor and Japan Heart Rhythm Society president Wataru Shimizu said: “The approval of ablation therapy using pulsed-field energy in Japan will further advance the treatment of arrhythmias. “Together with the integrated 3D mapping system, this innovation has the potential to provide more advanced treatment and further improve safety. “The increasing diversity of treatment technologies means that healthcare providers who seek to cure atrial fibrillation have options tailored to each patient’s condition.”

First regulatory approval for the first-of-its-kind, fully-integrated PFA system with a simple and reproducible workflow Integrated with the world's leading CARTO™ 3D cardiac mapping system for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AFib) First and only PFA system approved in Japan IRVINE, Calif., Jan. 9, 2024 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i today announced approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the VARIPULSE™ Platform for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AFib) using pulsed field ablation (PFA). The VARIPULSE™ Platform is comprised of the VARIPULSE™ Catheter, a variable-loop multielectrode catheter; the TRUPULSE™ Generator, a multichannel PFA generator; and CARTO™ 3 System, the world's leading 3D cardiac mapping system. The VARIPULSE™ Platform is the first and only CARTO™-integrated PFA system, enabling an intuitive and reproducible workflow with real-time visualization and feedback mechanisms. Continue Reading The VARIPULSE™ Platform is comprised of the VARIPULSE™ Catheter, a variable-loop multielectrode catheter; the TRUPULSE™ Generator, a multichannel PFA generator; and CARTO™ 3 System, the world’s leading 3D cardiac mapping system. VARIPULSE LA Map "At Biosense Webster, we are working to deliver a differentiated PFA portfolio integrated with 3D cardiac mapping to address the real-world, unmet needs of electrophysiologists and the patients they treat. Today, we celebrate this milestone approval of the VARIPULSE™ Platform, the first and only PFA system approved in Japan," said Jasmina Brooks, President, Biosense Webster. "We are excited to continue to advance PFA clinical studies globally and look forward to the positive impact this innovation will deliver to patients everywhere." The inspIRE trial early clinical results with the VARIPULSE™ Platform in Europe demonstrated a one-year clinical success of 78.9%, defined as freedom from documented symptomatic atrial arrhythmia recurence.1 The trial also demonstrated a notable safety profile, reporting no primary adverse events (0%)1. The platform's proprietary pulse sequence, catheter design, and CARTO™ 3 System integration enabled a simplified workflow and resulted in minimal fluoroscopy time (7.8 minutes) and efficient procedures (70 minutes)1. "The innovation in catheter ablation therapy for atrial fibrillation has been remarkable. The approval of ablation therapy using pulsed-field energy in Japan will further advance the treatment of arrhythmias. Together with the integrated 3D mapping system, this innovation has the potential to provide more advanced treatment and further improve safety," said Dr. Wataru Shimizu, President of the Japan Heart Rhythm Society (Professor, Department of Cardiovascular Medicine, Graduate School of Medicine, Nippon Medical School) ii. "The increasing diversity of treatment technologies means that healthcare providers who seek to cure atrial fibrillation have options tailored to each patient's condition." Catheter ablation is a minimally invasive procedure performed by an electrophysiologist to treat heart rhythm disorders, including AFib, by interrupting irregular electrical pathways in the heart by delivering either heat (radiofrequency 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.2 AFib is the most common type of cardiac arrhythmia, impacting nearly 38 million people worldwide and approximately 1.3 million people in Japan.3,4 Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options and the importance of early treatment to avoid risk of stroke and disease progression.5 The VARIPULSE™ Platform is pending CE mark in the European Union; it is not available for sale in the EU or United States. 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 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 Japanese Ministry of Health, Labour and Welfare (MHLW) approval of the VARIPULSE™ Catheter and TRUPULSE™ Generator. 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. 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 Biosense Webster, Inc. 2024. All rights reserved. M_US_BWI_THER_302055 i Johnson & Johnson MedTech comprises the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson's MedTech segment. ii Dr. Shimizu is a paid consultant for Johnson & Johnson K.K. 1 Duytschaever M, et al. Circ Arrhythm Electrophysiol. 2023;13(3):e011780. 3. Aguilar M, et al. Circulation. 2022;145(1):21–30 2 Reddy VY, Neuzil P, Koruth JS, et al. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. JACC 2019;74(3)315-326. 3 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. 4 Economic Burden of Atrial Fibrillation in Japan. Value in Health 2018; 21(2)S70. doi: 10.1016/j.jval.2018.07.530. 5 Kuck 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. PMID: 33330909 SOURCE Biosense Webster

This announcement follows last week’s 96th Annual Meeting of the Japanese Orthopaedic Association in Yokohama, Japan, where Exactech presented new research that showcases the ability to acquire joint laxities in the knee when using Newton over conventional techniques Exactech Accelerates International Expansion of Its Newton Balanced Knee Technology (Credit: Business Wire) Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced plans to accelerate the expansion of the Newton Knee to the Asia-Pacific region. This announcement follows last week’s 96th Annual Meeting of the Japanese Orthopaedic Association in Yokohama, Japan, where Exactech presented new research that showcases the ability to acquire joint laxities in the knee when using Newton over conventional techniques. One of the first surgeons to use the Newton Knee, Hiroshi Watanabe, MD, with the Nippon Medical School Musashikosugi Hospital in Kanagawa Prefecture, commented, “Total knee arthroplasty with navigation technology requires an optimal balancing technique to ensure the suitable knee laxity and motion. Exactech’s Newton technology and its tibia-first technique is the most promising solution to help solve those issues and evaluate the knee laxity more precisely.” The Newton Knee technique focuses on enhancing the surgical experience by providing valuable gap balance data to help achieve reproducible balance in total knee replacement procedures. Unlike other technologies, the Newton Knee technique utilizes a dynamic tensor to acquire real-time soft tissue data throughout the full arc of motion. Working in concert with the company’s pioneering ExactechGPS system, this powerful technology helps visualize postoperative joint balance and stability to help execute a personalized positional plan before any bony resections are performed. “Exactech is focusing its efforts and investments on unique surgical technologies that can most significantly improve clinical outcomes,” said Darin Johnson, Exactech President and Interim CEO. “The Newton balanced knee system provides surgeons with a robust platform of patient-specific insights that otherwise may not be available. Expanding access to this advanced technology into the APAC region is important for our company strategically, and for the surgeons and patients who can now benefit from this innovation.” Source: Company Press Release