Johnson & Johnson MedTech Introduces Ultrasound Catheter for ICE Imaging

May 21, 2025 – Johnson & Johnson MedTech has announced the U.S. launch of the Soundstar Crystal Ultrasound Catheter for intracardiac echocardiography (ICE) imaging in cardiac ablation procedures.  

The device provides clearer, enhanced image quality compared to other ICE cathetersⁱⁱ, representing an advanced 2D ICE catheter. Integrated with Carto 3 Mapping Systemⁱ, including the Cartosound FAM module for enhanced mapping capabilities powered by AI1ⁱⁱⁱ, Soundstar Crystal provides an efficient workflowⁱ. Cartosound FAM enables automatic generation of the left atrial anatomy by a novel artificial intelligence algorithm using images collected from a rotation of the ultrasound catheter in the right atrium, simplifying the integrated workflowⁱ for electrophysiologists performing cardiac ablation procedures for patients¹.  

“We are proud to advance our legacy in integrated ultrasound catheters with this latest innovation that equips electrophysiologists with the tools they need to promote patient safetyⁱⁱ and drive effective^iv results,” said Jasmina Brooks, president, Electrophysiology, Johnson & Johnson MedTech. “The superior image quality^i,ii , improved catheter maneuverabilityⁱⁱ and stability of the Soundstar Crystal Ultrasound Catheter, along with seamless Carto 3 System integrationⁱ can help enable a zero fluoroscopy workflowiv,^v,*,2,3,4,vi enhancing procedure effectiveness and safety for both healthcare professionals and patients they treat.” 

ICE is broadly used in catheter ablation procedures to visualize the heart in high resolution to monitor catheter-tissue contact and ablation in real-time and quickly detect procedural complications. When real-time imaging is integrated with a 3D electroanatomical mapping system, such as the Carto 3 System, ICE can help reconstruct cardiac anatomy and enable zero-fluoroscopy procedures^v*,2,3,4. ICE-guided electrophysiology procedures can be performed under conscious sedation, without requiring esophageal intubation and additional anesthesia^vii5. 

“During the cases I performed with the Soundstar Crystal Ultrasound Catheter, I was impressed by the clear visualization, tissue definition and enhanced far field imagingⁱ, and full integration with other platforms. Integration with the Carto 3 System provides clear, high-resolution images^i,viii which simplify the anatomical mapping process^ix and procedure workflow^v,” said Amin Al-Ahmad, MDx, St. David’s HealthCare, Austin, TX. 

The Soundstar Crystal Ultrasound Catheter is the latest addition to a comprehensive portfolio of ultrasound solutions at Johnson & Johnson MedTech. The company recently brought forward the Nuvision Catheter, which harnesses advanced 4D imaging to assist physicians performing cardiac procedures, such as Left Atrial Appendage Closure (LAAC).  

Cardiac arrhythmias are a growing epidemic. AFib alone is the most common type of cardiac arrhythmia and impacts more than 50 million people worldwide, and 8 million people in the U.S⁶. 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^7,8. Catheter ablation is a safe and effective procedure to restore the heart’s incorrect electrical signals, which causes an abnormal heart rhythm⁹. 

Learn more about our MedTech sector’s cardiovascular solutions at https://thenext.jnjmedtech.com.

^i. Based on Siemens' internal report CRF data responses as of 8/9/2024. CRF Data PN 11291187-EPT-021.
^ii. When compared to [Acuson AcuNav Ultrasound Catheter] [Soundstar Ultrasound Catheter]
^iii. Cartosound Fam Module uses Deep Learning, which is a subset of AI
^iv. Safety profile refers to complication and primary adverse event rates 
^* Efficacy profile refers to acute success (pulmonary vein isolation) and long-term success.
^v. Based on a survey of 31 physicians.
^vi. Johnson & Johnson and its affiliates' 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, Octaray Mapping Catheter with Trueref Technology, OotrellL Mapping Catheter with Trueref Technology, Decanav Mapping Catheters, and Webster CS Catheter.
^vii. Based on a meta analysis of ICE applications in EP
^viii. When compared to Soundstar Catheter
^ix. Based on 96 surveys, by 31 EPs with an average score of 5.0 or higher on 7-point Likert scale with 5=Satisfied 6/7=Completely Satisfied
^x. Dr. Al-Ahmad serves as a consultant for Johnson & Johnson but was not compensated for this announcement.  
 

1. CAartosound Fam Module Instructions for Use. UG_5462-018H P02. November 2023.

2. Debreceni D, Janosi K, Bocz B, et al. (2023). Zero fluoroscopy catheter ablation for atrial fibrillation: a systematic review and meta-analysis. Front Cardiovasc Med;10:1178783. doi: 10.3389/fcvm.2023.1178783.

3. Rajendra A, Hunter TD, Morales GX, et al. (2023). Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy. J Interv Card Electrophysiol;66(2):381-388. doi: 10.1007/s10840-022-01332-8.

4. Tahin T, Riba A, Nemeth B, et al. (2021). Implementation of a zero fluoroscopic workflow using a simplified intracardiac echocardiography guided method for catheter ablation of atrial fibrillation, including repeat procedures. BMC Cardiovasc Disord;21(1):407. doi: 10.1186/s12872-021-02219-8.

5. Tong Hu, Tongshuai Chen, Kellina Maduray, Wenqiang Han, Jingquan Zhong. Intracardiac Echocardiography: An Invaluable Tool in Electrophysiological Interventions for Atrial Fibrillation and Supraventricular Tachycardia. Rev. Cardiovasc. Med. 2024, 25(6), 191. https://doi.org/10.31083/j.rcm2506191.

6. Mensah, G, Fuster, V, Murray, C. et al. Global Burden of Cardiovascular Diseases and Risks, 1990-2022. J Am Coll Cardiol. 2023 Dec, 82 (25) 2350–2473.

7. Calkins, H., et al (2017). 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart rhythm, 14(10), e275–e444.

8. Odutayo, A. et al (2016). Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ (Clinical research ed.), 354, i4482.

9. Natale, A. et al (2014). 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, 64(7), 647–656.