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Biosense Webster
HELIOSTAR™ Balloon Ablation Catheter
Biosense Webster
HELIOSTAR™ Balloon Ablation Catheter
The HELIOSTAR™ Balloon Ablation Catheter is fully integrated with the CARTO® 3 System, enabling an efficient, customisable, and low fluoroscopy workflow for PV isolation.*,1,2
IMAGES
Features and Benefits
Customisable Energy Delivery1
- Automatically titrate energy delivery based on anatomical location1
- Perform circumferential or segmental ablation1
CARTO® integration***,1,6
- Visualise and navigate the balloon in real- time for potential fluoroscopy reduction5,6,8
- Monitor ablation parameters***,1,5
Optimal Anatomical Fit1,6
- Compliant 28 mm balloon1,6
- Conforms to varied PV anatomy1,6
Real-time PVI Validation****,1,5-7
Assess signals during PV isolation1,8
Perform voltage mapping post-ablation7
HELIOSTAR™ Catheter Live Case Demonstration at Boston AF Symposium, 2019
Supporting Documentation
Resources
References
* Based on multicenter single-arm study SHINE (n=95).
** In a multicenter single-arm study, total procedure time was 87.6 ± 22.25 minutes (n = 95, roll-ins = 8 patients. Per protocol, a roll-in phase of up to 3 patients per physician was implemented).
*** When using the HELIOSTAR™ Balloon Ablation Catheter.
**** With the LASSOSTAR™ Catheter.
- SHINE Study Clinical Study Report (BWI_2017_01 12M Final Results). December 20, 2019.
- Calkins, et al, 2017HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation, Europace (2018) 20, e1–e160.
- Schilling, R., Dhillon, G., Tondo C., et al. Safety, Effectiveness, and Quality of Life Following Pulmonary Vein Isolation with a Multi-Electrode Radiofrequency Balloon Catheter in Paroxysmal Atrial Fibrillation: One Year Outcomes from SHINE. Europace, 2020. Accepted for formal publication.
- Dhillon, G., Schilling, R. et al. Use of a Multi-Electrode Radiofrequency Balloon Catheter to Achieve Pulmonary Vein Isolation in Patients with Paroxysmal Atrial Fibrillation: Twelve-month outcomes of the RADIANCE Study. Journal of Electrophysiology, April 2020. doi: 10.1111/jce.14476.
- HELIOSTAR™ Balloon Ablation Catheter IFU and Release Notes. UG5450-017. June 2020.
- HELIOSTAR™ Balloon Ablation Catheter Instructions for Use. M-5276-1052B.
- Biosense Webster, Inc. Internal Design Validation Test Report (TR-0022056, June 27, 2017).
- LASSOSTAR™ Circular Mapping Catheter Instructions for Use. M-5276-1005B.
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©Biosense Webster, Inc. 2020 Last Updated on 1/5/20.