Biosense Webster Launches the OCTARAY Mapping Catheter with TRUErefTechnology

September 8, 2022 — Biosense Webster, Inc., part of Johnson & Johnson MedTech^‡, announced the release of the OCTARAY Mapping Catheter with TRUEref Technology powered by the CARTO 3 Version 7 System. The OCTARAY Mapping Catheter was developed for the mapping of cardiac arrhythmias, including atrial fibrillation (AFib). The catheter has eight splines with improved electrode spacing options to provide shorter and more efficient mapping times than PENTARAY NAV ECO Mapping Catheter, which may shorten overall ablation procedure times.^2,8§

AFib is the most common type of cardiac arrhythmia and impacts nearly 40 million people worldwide.³ 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.^4,5 Catheter ablation is a safe and effective procedure to restore the heart's incorrect electrical signals, which causes an abnormal heart rhythm.⁶ The OCTARAY Mapping Catheter can map arrhythmias in any chamber and provides physicians with enhanced clarity, speed and integration to quickly capture precise information for their catheter ablation procedures.^1,2†

"With more splines and electrodes, the increased surface area coverage and improved signal quality with the OCTARAY Mapping Catheter allows me to better understand the anatomy and conduction properties of the chamber of interest," said Dr. Amit Thosani, Director of Cardiac Electrophysiology at Allegheny Health Network.* "This catheter not only helps me to map more accurately and efficiently, but also allows for better patient specific therapy."

TRUEref Technology is a novel mapping reference electrode that reduces the impact of farfield signals.^7** The catheter has forty-eight small mapping electrodes on eight splines, reduced electrode size and tight electrode spacing.^1†† The OCTARAY Mapping Catheter with TRUEref Technology accurately identifies lesion set gaps,^1‡‡ and improves characterization of lesion sets compared to the PENTARAY NAV ECO High Density Mapping Catheter.^1§§ The catheter allows for mapping with greater precision and detail with improved signal quality.^1***

"I am excited about the addition of the OCTARAY™ Mapping Catheter to the suite of tools available to map cardiac arrhythmias at my institution," said Dr. Benjamin Berte, Co-Chief Physician and Co-Head of Electrophysiology, Cantonal Hospital of Lucerne, Switzerland**. "As the prevalence of patients with AFib continues to rise, physicians need innovative tools to deliver more efficient and effective procedures to benefit their patients."

"Building on Biosense Webster's three decades of leadership in the science and technology of cardiac ablation, we are proud to bring forward the new OCTARAY Mapping Catheter with TRUEref Technology as the newest mapping tool for electrophysiologists in the U.S. and EMEA," said Michael Bodner, Ph.D., Worldwide President, Biosense Webster, Inc. "With shorter and more efficient mapping time, the catheter benefits both the patient and the physician, allowing for shorter procedure times while enabling greater accuracy and detail."

The OCTARAY Mapping Catheter with TRUEref Technology is now available in the U.S. and EMEA and has been both CE marked and 510(k) cleared by the U.S. Food and Drug Administration (FDA). For more information, visit the OCTARAY page on our website.

References:

*Dr. Thosani is compensated by and presenting on behalf of BWI and must present information in accordance with applicable regulatory requirements.

^† Pre-clinical test data are not necessarily indicative of clinical performance.

^‡ Johnson & Johnson MedTech comprises the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson's MedTech segment.

^§ Unadjusted comparison of competitive technologies, based on OCTARAY Mapping Catheter results from a single arm (n=31) trial and pre-clinical (n=8) results. Pre-clinical test data are not necessarily indicative of clinical performance

^** Compared to Wison's Central Terminal (WCT). Based on a benchtop study (n=3).

^†† Compared to the PENTARAY NAV ECO High Density Mapping Catheter. Based on a single-center, pre-clinical study (n=8).

**Dr. Berte is compensated by and presenting on behalf of BWI and must present information in accordance with applicable regulatory requirements.

^‡‡ Based on a single-center, pre-clinical study (n=8), a comparison of OCTARAY Mapping Catheter 2-2-2-2-2 vs. PENTARAY NAV ECO High Density Mapping Catheter 2-6-2. Pre-clinical test data are not necessarily indicative of clinical performance.

^§§ Study was a comparison of OCTARAY Mapping Catheter 2-2-2 vs PENTARAY Catheter 2-6-2

^*** Compared to the PENTARAY NAV ECO High Density Mapping Catheter. Based on a single-center, preclinical study (n=8) and benchtop study.

1 _{Sroubek J, Rottman M, Barkagan M, et al. (2019) A novel octaray multielectrode catheter for high-resolution atrial mapping: electorcardiogram characterization and utility for mapping ablation gaps. J Cardiovasc Electrophysiol:1-9.}

2 _{Barkagan M, Sroubek J, Shapira-Daniels A et al. (2020) A novel multielectrode catheter for high-density ventricular mapping: electrogram characterization and utility for scar mapping, Europace (0): 1-10.}

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 _{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.}

5 _{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.}

6 _{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.}

⁷ _{Engineering Report for Evaluation of TRUEref™ Technology for Far-Field Signal Reduction, TR-0028829, Rev. A}

⁸ _{OCTARAY-FIM Study Clinical Study Report. July 17, 2019. BWI_2017_05.}