Tachycardia, Ectopic Atrial

The Varipulse Platform comprises the Varipulse Catheter, a variable-loop multielectrode catheter; Trupulse Generator, a multichannel PFA generator; and Carto 3 System is a 3D cardiac mapping system, to treat paroxysmal atrial fibrillation (AF) Biosense Webster Varipulse PFA Platform. (Credit: Medical Device Business Services) Biosense Webster, a part of Johnson & Johnson MedTech, has received the CE mark approval for its Varipulse pulsed field ablation (PFA) Platform to treat a type of atrial fibrillation (AF) The Varipulse Platform, which comprises the Varipulse Catheter, Trupulse Generator, and Carto 3 System, is intended to treat symptomatic drug refractory recurrent paroxysmal AF. Varipulse Catheter is a variable-loop multielectrode catheter, Trupulse Generator is a multichannel PFA generator and Carto 3 System is a 3D cardiac mapping system. According to the company, the Varipulse Platform is the first and only Carto-integrated PFA system that enables reproducible workflow with real-time visualisation and feedback set-up. Biosense Webster president Jasmina Brooks said: “At Biosense Webster, we continually seek to push the boundaries of science and technology innovation in cardiac ablation. “CE mark approval of the VARIPULSE Platform is testament to this, now offering healthcare professionals the potential to improve outcomes for people living with atrial fibrillation while setting a new standard in cardiac electrophysiological mapping. “We believe pulsed field ablation has the potential to offer safer, more consistent and efficient workflows, and the VARIPULSE Platform uniquely offers physicians a simple and reproducible PFA workflow with 3D visualization, in real-time.” Biosense Webster said that the safety and efficacy of the Varipulse Platform were validated in the inspIRE trial, which included 186 patients in Canada and Europe. In the study, 80% of the participants who received optimal PFA applications, reached the primary effectiveness endpoint, freedom from recurrence with no primary adverse events. Also, the primary effectiveness endpoint (PEE) of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AF, Atrial Tachycardia, or Atrial Flutter). The combination of the Varipulse Catheter and Carto 3 System in the study partly resulted in a low fluoroscopy time of 7.8 minutes, and a good safety pro no primary adverse events. Earlier this year, Biosense Webster secured Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for the Varipulse pulsed field ablation (PFA) platform.

Final results from inspIRE study demonstrate 80% freedom from atrial arrhythmia recurrence at 12 months in patients with optimal Pulsed Field Ablation applications First look results from admIRE study suggests similar outcomes IRVINE, Calif., Feb. 2, 2024 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTechi, announced 12-month results from the company-sponsored inspIRE study, "Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation (PFA) Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE," presented as a late-breaking presentation at the 29th Annual International AF Symposium.1 Interim results from the company-sponsored admIRE study, titled "PFA Using a Variable Loop Circular Catheter with 3D Mapping Integration: Early Outcomes of the admIRE Study," were also shared in a late-breaking presentation.2 Both the inspIRE and admIRE studies were conducted using the Biosense Webster VARIPULSE™ Platform, consisting of the VARIPULSE™ Catheter – a fully integrated variable-loop multielectrode catheter; the TRUPULSE™ Generator – a multichannel PFA generator; and the CARTO™ 3 System VARIPULSE™ Service Pack Software, which provides full integration with the world's leading 3D cardiac mapping system. The CARTO™ System enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms. "Biosense Webster is committed to bringing forward a versatile, differentiated portfolio of PFA solutions designed to help electrophysiologists deliver safe, effective, and efficient cardiac ablation procedures," said Jasmina Brooks, President, Biosense Webster, Inc. "The encouraging outcomes from clinical trials with VARIPULSE™ fuel our excitement as we continue to deliver innovations to meet the diverse needs and ablation strategies required to successfully treat atrial fibrillation." Data from inspIRE Demonstrate 80% of Patients Achieved Freedom from Recurrence with Zero Primary Adverse Events The inspIRE study evaluated the safety and effectiveness of the VARIPULSE™ Platform for the treatment of drug-refractory paroxysmal AFib in Europe and Canada.1 In the study, the primary effectiveness endpoint of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AFib, Atrial Tachycardia, or Atrial Flutter) was 75.6%. Among participants receiving optimal PFA applications, 80% achieved the primary effectiveness endpoint.1 The study reported a low fluoroscopy time of 7.8 minutes, partly attributed to the integration of the VARIPULSE™ Platform to the CARTO™ 3 System. The safety results demonstrated a primary adverse event rate of 0.0%ii.1 "High efficacy of 80% freedom from atrial recurrence at 12 months and a strong safety profile are promising evidence of the capabilities of the VARIPULSE™ Platform," said Vivek Y. Reddy, M.D., Director of Electrophysiology at the Mount Sinai Fuster Heart Hospital and The Helmsley Trust Professor of Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai, corresponding author for the inspIRE study publication.iii "As the VARIPULSE™ Platform was designed to integrate seamlessly with the CARTO™ 3 Mapping System, this technology should be able to effectively treat patients with atrial fibrillation with low radiation exposure to patients and lab staff alike." admIRE Pilot Results Show All Pilot Phase Patients Achieved Acute Success and 80% Remained Free from Atrial Arrhythmia Recurrence After One Year Twelve-month outcomes data from the pilot phase of the admIRE study, which assessed the safety and efficacy of the VARIPULSE™ Platform among U.S. patients, were presented as a late-breaker at the AF Symposium.2 Among 20 patients who completed the 12-month follow-up visit, 100% achieved acute success from ablation procedures and 80% remained free from atrial arrhythmia recurrence at one year.2 No procedure or device-related primary adverse events were reported in the pilot phase of the study.2 For patients who had received ablation, median procedure and fluoroscopy times were 90.0 and 3.5 minutes, respectively, as a result of the CARTO™ integration.2 "The results observed in the pilot phase of the admIRE study point to the promise of the VARIPULSE™ Platform in treating patients with paroxysmal AFib," said David Newton, M.D., Clinical Cardiac Electrophysiologist, Memorial Health University Medical Center, Savannah, Georgia.iv "These initial results are encouraging and demonstrate the potential for the VARIPULSE™ Platform to become a key component of the suite of tools electrophysiologists have at their disposal to perform catheter ablations." 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.3,4 Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib.5 Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options, and the importance of early treatment to avoid disease progression.6 Catheter ablation is a safe and effective procedure when drugs don't work to help restore the heart's incorrect electrical signals, which cause an abnormal heart rhythm.7 About inspIRE The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by PFA System With Irreversible Electroporation [IRE]) (NCT04524364) was a prospective, multi-center, single-arm study of drug-refractory PAF, conducted at 13 institutions in Canada and Europe, from March 2021 to May 2022. In the study, PVI was performed with the VARIPULSE™ Platform. Follow up with 24-hour Holter monitoring was performed at three, six, and 12 months. Remote rhythm monitoring was performed weekly from three to five months; monthly, from six to 12 months; and for symptoms. The primary effectiveness endpoint (PEE) was acute PVI plus freedom from all atrial arrhythmia (AFib, Atrial Tachycardia, or Atrial Flutter), at 12 months. This final analysis of the study focused on the pivotal phase (Wave II) per-protocol population of 186 patients with 12 months of follow up. About admIRE The admIRE study (Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the Biosense Webster IRE Ablation System) (NCT05293639) is a prospective, multi-center, single-arm study to demonstrate the safety and long-term effectiveness of the VARIPULSE™ Platform when used for isolation of pulmonary veins in treatment of patients in the United States with symptomatic drug refractory paroxysmal AFib. Pulmonary vein isolation (PVI) was achieved using the VARIPULSE™ Platform. The study consisted of a pilot phase, which assessed initial device safety and effectiveness, and a pivotal phase, which assessed these against pre-specified performance goals. The primary safety endpoint was incidence of early onset (within seven days) primary adverse events; atrio-esophageal fistula (within 90 days); cardiac tamponade or perforation (within 30 days); and PV stenosis (within 12 months). Acute procedure success (defined as confirmed entrance block at the end of procedure) and freedom from documented atrial arrhythmia recurrence at 12 months were also assessed. About the VARIPULSE™ Platform The VARIPULSE™ Platform is Biosense Webster's Irreversible Electroporation ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Service Pack Software. In January 2024, Biosense Webster announced that the VARIPULSE™ Platform received its first regulatory approval from the Japan Ministry of Health, Labour and Welfare for the treatment of symptomatic drug refractory recurrent paroxysmal AFib using PFA. In the U.S., the VARIPULSE™ Catheter and TRUPULSE™ Generator are currently investigational and are not approved by regulatory authorities. In Europe, the TRUPULSE™ generator received CE mark in late 2023 and VARIPULSE™ Catheter is pending CE mark. 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 biosensewebster.com and connect on LinkedIn and X, formerly Twitter. About Johnson & Johnson MedTechii 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 VARIPULSE™ Platform clinical trials. 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. © Johnson & Johnson Biosense Webster, Inc. 2024. All rights reserved. US_BWI_THER_303927.1 i Johnson & Johnson MedTech comprises the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson's MedTech segment. ii Primary adverse events were defined as myocardial infarction, thromboembolism, transient ischemic attack, diaphragmatic paralysis, pneumothorax, heart block, pulmonary edema, vagal nerve injury, pericarditis, major vascular access complication or bleeding, death, stroke, or any other cerebrovascular accident. Atrioesophageal fistula and PV stenosis occurring >7 days post ablation along with cardiac tamponade or perforations occurring within 30 days of the ablation procedure were also considered primary adverse events. iii Nemocnice na Homolce entered into a clinical trial agreement with Johnson & Johnson Medical NV/SA for their participation in the inspIRE Study. Dr. Reddy served as a study coinvestigator. Dr. Reddy was compensated for consultancy purposes for his Multielectrode IRE Catheter Program Study Advisory Committee membership. Dr. Reddy was not compensated for this authorship contributions. iv Memorial HCA Savannah entered into a clinical trial agreement with Biosense Webster, Inc. for their participation in the admIRE Study. Dr. Newton served as a study coinvestigator. Dr. Newton serves as a consultant for BWI. Dr. Newton was not compensated for this authorship contributions. 1 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. 2 Newton D, Natale A, Mansour M, Nair D, Senn T. Pulsed Field Ablation Using a Variable Loop Circular Catheter with 3D Mapping Integration: Early Outcomes of the admIRE Study [abstract]. In: AF Symposium.; February 2-4; Boston. 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. Epub 2020 Jan 19. Erratum in: Int J Stroke. 2020 Jan 28;1747493020905964. PMID: 31955707. 4 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 5 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 6 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. 7 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 SOURCE Biosense Webster

The clinical trial will evaluate the safety and effectiveness of the PFA system as a first-line treatment for patients with persistent AF, compared to outcomes with anti-arrhythmic drug (AAD) therapy, a common treatment for patients living with persistent AF Boston Scientific to study FARAPULSE PFA system. (Credit: jesse orrico on Unsplash) US-based biomedical engineering firm Boston Scientific has initiated the AVANT GUARD clinical study of its FARAPULSE pulsed field ablation (PFA) system for atrial fibrillation (AF). The clinical trial will evaluate the safety and effectiveness of the PFA system as a first-line treatment for patients with persistent AF. The Farapulse PFA System is designed to optimise cardiac PFA therapy, a non-thermal treatment where electric fields selectively ablate heart tissue. It comprises a Steerable Sheath for access and navigation, a PFA Catheter to treat a range of PV anatomies, and a PFA Generator for an easy three-button click. The study will compare the outcomes of ablation with Farapulse PFA System, to outcomes with anti-arrhythmic drug (AAD) therapy, a common treatment for patients living with persistent AF. Boston Scientific AF Solutions chief medical officer Brad Sutton said: “With nearly 40,000 patients treated to date in clinical and commercial settings, the FARAPULSE PFA System continues to demonstrate a promising safety and effectiveness profile, upon which this study seeks to build. “The AVANT GUARD trial is exciting in that it has the potential to change clinical practice by advancing the therapy to be utilised as an earlier treatment for persistent AF, which may lead to better long-term outcomes and establish the FARAPULSE PFA System as the preferred method for treating the disease.” The AVANT GUARD randomised clinical trial is designed to enrol more than 500 patients diagnosed with persistent AF, at up to 75 sites worldwide. The study participants will be randomised to undergo pulmonary vein isolation (PVI) and left atrial posterior wall ablation using the FARAPULSE PFA system, or AAD treatment. The trial will evaluate the outcomes of treatment with the FARAPULSE PFA System compared to AADs, including device- or procedure-related adverse events. The study will also compare the rates of freedom from AF, atrial flutter, or atrial tachycardia, along with AF burden, a measurement of the amount of AF an individual experiences. All patients in the trial will also be inserted with the Boston Scientific LUX-Dx Insertable Cardiac Monitor, which simplifies the monitoring process for patients. LUX-Dx monitor is designed to detect the recurrence of cardiac arrhythmias, evaluate the AF burden, and automatically capture and transmit arrhythmia episode data. Recently, the Cleveland Clinic enrolled the first patient in the AVANT GUARD trial, who is also serving as the lead investigator of the trial.