SOUNDSTAR™ Ultrasound Catheter
The SOUNDSTAR™ Ultrasound Catheter with the CARTOSOUND™ FAM Module delivers real-time intracardiac echocardiography imaging and navigation to enable workflow efficiencies, such as real-time monitoring of the ablation catheter tip to reduce radiation exposure and improve confidence.1,2
Features & benefits
Precise Real-Time Visualization
- Identify and map the comprehensive cardiac anatomy
- Interpret ultrasound in the familiar CARTO™ 3 System environment
- Monitor tip-to-tissue contact with the green tip overlay feature
- Identify and map the transseptal puncture to ease left atrial access
- Identify and map the esophagus for orientation purposes
CARTOSOUND™ FAM Integration
Powered by Artificial Intelligence (AI), CARTOSOUND™ FAM Module reconstructs the left atrial (LA) anatomy on the CARTO™ 3 System with a few rotations of your ultrasound catheter, eliminating the need for manual contouring.*3,4
Zero fluoro. Zero compromise.**
Our Johnson & Johnson MedTech electrophysiology portfolio is the first and only integrated ecosystem indicated to be used as part of zero fluoroscopy workflow for atrial fibrillation (AFib) treatment. Anchored by the CARTO™ 3 System, our diagnostic, ablation and intracardiac echocardiography (ICE) products help to enable efficient and safe cardiac ablation procedures while eliminating risks associated with fluoroscopy.
Learn more about this product
Supporting documentation
Related products
NUVISION™ NAV Ultrasound Catheter
NUVISION™ NAV Ultrasound Catheter is the most comprehensive 4D ICE guidance available for concomitant procedures.
SOUNDSTAR CRYSTAL™ Ultrasound Catheter
Integrated with the CARTOSOUND™ FAM Module, SOUNDSTAR CRYSTAL™ Ultrasound Catheter offers clear visualization and tissue definition with enhanced far field imaging, giving users added confidence in procedures and elevating the CARTO™ 3 System experience.
References
*CARTOSOUND™ FAM Module uses Deep Learning, which is a subset of AI.
**Biosense Webster, Inc.’s 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, DECANAV™ Mapping Catheters, and Webster™ CS Catheter
- Pier Luigi Pellegrino, Natale D. Brunetti, Daniela Gravina, Daniele Sacchetta, Valerio De Sanctis, Stefania Panigada, Luigi Di Biase, Matteo Di Biase and Massimo Mantica Nonfluoroscopic mapping reduces radiation exposure in ablation of atrial fibrillation. Cardiovasc Med 2013, 14:528–533
- Marian Christoph1, Carsten Wunderlich, Stefanie Moebius, Mathias Forkmann, Judith Sitzy, Jozef Salmas, Julia Mayer, Yan Huo, Christopher Piorkowski, and Thomas Gaspar Fluoroscopy integrated 3D mapping significantly reduces radiation exposure during ablation for a wide spectrum of cardiac arrhythmias. Europace (2015) 17, 928–937
- 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.
- CARTOSOUND™ FAM Module Instructions for Use. UG_5462-00A. February 2024
Always verify catheter tip location using common clinical practice for real-time verification (inspection of IC signals, direct imaging guidance such as fluoroscopy or ultrasound, etc.) and consult the CARTO™ 3 System User Guide regarding recommendations for fluoroscopy use.Canpolat, U. et al (2020). State of Fluoroless Procedures in Cardiac Electrophysiology Practice. J Innov Cardiac Rhythm Management. 11(3), 4018–4029.Sommer, P. et al (2018) Safety profile of near-zero fluoroscopy atrial fibrillation ablation with non-fluoroscopic catheter visualization: experience from 1000 consecutive procedures, EP Europace, Volume 20, Issue 12, Pages 1952–1958.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions. Caution: US law restricts this device to sale by or on the order of a physician.
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