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HELIOSTAR™ Balloon Ablation Catheter
HELIOSTAR™ Balloon Ablation Catheter
HELIOSTAR™ Balloon Ablation Catheter’s unique, one-shot balloon technology enables PV isolation (PVI) in 12 seconds, with customsed energy delivery and one integrated 3D mapping solution.1
12 Seconds to PVI Isolation1*
Elevating the Balloon Experience2
Single-Shot Meets Personalisation3
Features and Benefits
- Access all pulmonary veins with ease3**
- 28mm compliant balloon conforms to varied PV anatomy2,3***
- Visualise and navigate the balloon in real time for fluoroscopy reduction3,i,ii
- Monitor electrograms and ablation parameters3,4
- Address common ostia efficiently2,3
- Independently turn on/off any of the 10 irrigated electrodes3
Tailored Energy Delivery2,3
- Titrate power to individual electrodes based on anatomical location2,3
- Energy delivery is automatically disabled to posterior electrodes at 20 seconds and to anterior electrodes at 60 seconds2,3
Seconds average time to isolation1*
Freedom from documented atrial arrhythmia at 12 months2,5,iii
Of veins isolated without focal touch-up3,iv
Achieve One-Shot PVI in 12 Seconds6
Clinical Results and Optimized Workflows with the HELIOSTAR™ Balloon Ablation Catheter.
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GUIDESTAR™ Deflectable Sheath
LASSOSTAR™ NAV Catheter
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*In a multi‐center single‐arm study (SHINE, n=95), pure single shot isolation was achieved by one initial RF application (regardless of the duration of ablation). Time to isolation (mean ± SD, sec) was 9.0 ± 6.46 (LIPV), 12.0 ± 11.58, (LSPV), 9.1 ± 4.95 (RIPV), 8.9 ± 6.22 (RSPV).
**In a multicentre single‐arm study (SHINE, n=95), 98.8% of PVs were isolated without the need for focal touch‐up catheter.
***In a multicenter, single‐arm study SHINE (n = 95), 100% of the targeted PVs were electrically isolated and no additional ablation with a focal ablation catheter was necessary.
- In a multicenter, single‐arm study, average procedural time improved from 158.4 ± 59.05 min (roll‐in cases) to 87.6 ±22.25 min (evaluable cases). This data is based on 7 operators (all were experienced balloon users). A subset of roll‐in procedures included acquisition of voltage maps which resulted in approximately 5 min additional procedure time. Total procedural time defined as time from first femoral puncture to last catheter removed.
- Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO™ 3 System User Guide regarding recommendations for fluoroscopy use. Pellegrino, P.L., Brunetti, N.D., Gravina, D., Sacchetta, D., De Sanctis, V., Panigada, S., Di Biase, L., Di Biase, M., and Mantica, M. (2013). Nonfluoroscopic mapping reduces radiation exposure in ablation of atrial fibrillation. Journal of cardiovascular medicine 14, 528‐533. Earley, M.J., Showkathali, R., Alzetani, M., Kistler, P.M., Gupta, D., Abrams, D.J., Horrocks, J.A., Harris, S.J., Sporton, S.C., and Schilling, R.J. (2006). Radiofrequency ablation of arrhythmias guided by non‐ fluoroscopic catheter location: a prospective randomized trial. Eur Heart J 27, 1223‐1229.
- 86.4% (32/37) includes those both on/off AAD; 75.7% (28/37) off AAD. Based on n=37/39 pts, observational study.
- In a multicenter, single‐arm study SHINE (n = 95).
- Schilling, R. et al (2021). Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi‐electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1‐year outcomes from SHINE. Europace, 23(6), 851–860.
- HELIOSTAR™ Balloon Ablation Catheter Instructions for Use. M‐5276‐1052. Release date 6/7/2021.
- SHINE Study Clinical Study Report (BWI_2017_01 12M Final Results). December 20, 2019.
- LASSOSTAR™ NAV Circular Mapping Catheter Instructions for Use. M‐5276‐1054.
- 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.
- Almorad, A. et al (2022). The optimized clinical workflow for pulmonary vein isolation with the radiofrequency balloon. JICE, 64(2), 531–538.
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