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Johnson & Johnson MedTech receives CE Mark for OPTRELL™ Mapping Catheter with TRUEref™ Technology for Mapping of Complex Cardiac Arrhythmias

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Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i today announced the CE mark of the OPTRELL™ Mapping Catheter with TRUEref™ Technology powered by the CARTO™ 3 System. The OPTRELL™ Mapping Catheter is a high-density diagnostic catheter, with small electrodes arranged in a fixed array formation to provide high-definition electrophysiological mapping of complex cardiac arrhythmia cases like persistent atrial fibrillation (AFib), redo AFib ablation, atrial tachycardia, and ventricular tachycardia.

Cardiac arrhythmias are a growing epidemic. AFib is the most common type of cardiac arrhythmia12 and impacts nearly 50 million people worldwide.1,2 AFib is a progressive disease, and if left untreated can get worse over time or lead to other serious complications like heart disease or stroke.3,4 Catheter ablation is a safe and effective procedure to restore the heart’s incorrect electrical signals, which causes an abnormal heart rhythm.5

This new catheter includes 36 electrodes symmetrically distributed across and along six splines and combines with the CARTO™ 3 System to deliver intelligent insights and high-resolution directional mapping.6 Additionally, the OPTRELL™ Mapping Catheter has tight electrode 2.4mm spacing and small electrodes, which produce higher signal resolution, resulting in enhanced maps of the heart.7,8 With these high-definition maps, clinicians have a better understanding of where the arrhythmia is occurring and can develop a more effective ablation strategy. 

The OPTRELL™ Mapping Catheter is powered by the CARTO™ 3 System, which offers Local Conduction Vectors that display the real-time direction and speed of the electrical impulses traveling through the heart.9 With these Local Conduction Vectors, clinicians gain enhanced understanding of complex circuits and mechanisms and can confidently detect gaps in ablation lesions.7 Together, these technologies can help clinicians identify 2 times better differentiation between conduction block, slow conduction or wavefront collision vs conventional LAT mapping10+. The OPTRELL™ Mapping Catheter is also enhanced by the Multipolar Technology that reduces significantly far field potentials of the localized unipolar signals and provide a more accurate activation map* resulting in 95% accurate annotation11**.

“OPTRELL™ Mapping Catheter with Multipolar Technology significantly enhances the accuracy of voltage and activation maps, especially in scar and border zones, by reducing high voltage far-field components,” said Elad Anter***, M.D., Director of the Arrhythmia Institute at Shamir Medical Center, Tel Aviv University. “This multipolar electrogram preserves the morphology of the local unipolar waveform, facilitating the determination of wave propagation direction. This advanced technology enables more effective identification of the arrhythmia substrate and the development of targeted ablation strategies for both atrial and ventricular arrhythmias.'”

Left atrial map with OPTRELL™ Catheter and CARTO™ 3 system V8


“The OPTRELL™ Mapping Catheter rounds out the Biosense Webster diagnostic mapping portfolio, providing physicians with a comprehensive set of tools, integrated with our CARTO™ 3 mapping system, to diagnose and treat arrhythmias,” said Jasmina Brooks, President, Biosense Webster, Inc. “This is the latest example of the continued commitment of Biosense Webster to providing clinicians with innovative tools to improve efficiency and effectiveness of procedures and quality of care for patients.”
The OPTRELL™ Mapping Catheter with TRUEref™ Technology received CE mark in August 2024 and is now available in Europe, UK, UAE and Africa.

Left atrial map with complex signals tagged automatically with the OPTRELL™ Catheter and OPTRELL™ Catheter

About Biosense Webster
Biosense Webster, part of Johnson & Johnson MedTech, leads in cardiac arrhythmia diagnosis and treatment worldwide. We are dedicated to advancing electrophysiology and interventional cardiology tools and solutions for improved patient care. Learn more at 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. For more information, visit jnjmedtech.com.

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 OPTRELL™ Mapping Catheter with TRUEref™ technology. 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., any of the other Johnson & Johnson MedTech companies 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 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 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., Johnson & Johnson MedTech nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Important Information: For product details such as indications, contraindications, warnings and precautions please consult the IFU. Johnson & Johnson MedTech bears no responsibility for the accuracy, legality or content of the external site.

Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.

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© Johnson & Johnson NV/SA 2024

*Compared to previous version of CARTO™ 3 System software. The preclinical validation was conducted using retrospective analysis of 4 atrial flutter maps with or without pacing (2xRA and 2xLA) and 12 ventricular maps (3xVTs and 9x ischemic OPTRELL™ (part number D-1409) Catheter on CARTO™ 3 System.
** when using OPTRELL™ Mapping Catheter with CARTO™ 3 System V8
+ compared to standard mapping
*** Prof. Elad Anter was not compensated for his contributions to this announcement

References:

  1. 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.
  2. 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
  3. Hugh Calkins, Gerhard Hindricks, Ricardo Cappato, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter ablation and surgical ablation of atrial fibrillation. 2017.
  4. Odutayo A, Wong CX, Hsiao AJ, Hopewell S, Altman DG et al. (2016) Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. Bmj 354 i4482.
  5. Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H. 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 Aug 19;64(7):647-56.
  6. OPTIMUM Study, Clinical Evaluation of Arrhythmia Mapping with the Multi-Electrode OPTRELL™ Mapping Catheter. Protocol # BWI_2019_02. 28 Jan 2022.
  7. Yavin H et al. Propagation Vectors Facilitate Differentiation Between Conduction Block, Slow Conduction, and Wavefront Collision. Circ Arrhythm Electrophysiol. 2021 Aug;14(8):e010081.
  8. Takigawa M et al. Impact of Spacing and Orientation on the Scar Threshold With a High-Density Grid Catheter. Circ Arrhythm Electrophysiol. 2019 Sep;12(9):e007158. doi: 10.1161/CIRCEP.119.007158. Epub 2019 Aug 26. PMID: 31446771.
  9. OPTRELL™ 36 Catheter Support. Instructions for Use and Release Notes. UG-5406-018H.
  10. Yavin HD, Bubar ZP, Higuchi K, Sroubek J, Yarnitsky J, Anter E. Propagation Vectors Facilitate Differentiation Between Conduction Block, Slow Conduction, and Wavefront Collision. Circ Arrhythm Electrophysiol. 2021 Aug;14(8):e010081
  11. Anter, E. Et al. Multipolar Electrograms A New Configuration That Increases the Measurement Accuracy of Intracardiac Signals. JACC. 2024. doi.org/10.1016/j.jacep.2024.04.009
  12. Center for Disease Control and Prevention.Atrial Fibrillation. Accessed 1/3/2022