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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
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
Product Resources
HELIOSTAR™ Catheter Live Case Demonstration at Boston AF Symposium, 2019
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.
1. SHINE Study Clinical Study Report (BWI_2017_01 12M Final Results). December 20, 2019.
2. Calkins, et al, 2017HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation, Europace (2018) 20, e1–e160.
3. 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.
4. 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.
5. HELIOSTAR™ Balloon Ablation Catheter IFU and Release Notes. UG5450-017. June 2020.
6. HELIOSTAR™ Balloon Ablation Catheter Instructions for Use. M-5276-1052B.
7. Biosense Webster, Inc. Internal Design Validation Test Report (TR-0022056, June 27, 2017).
8. LASSOSTAR™ Circular Mapping Catheter Instructions for Use. M-5276-1005B.
158952-201112
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