Clinical Evidence
Evidence for the Unique and Effective Tip1
The flexible tip design of the FlexAbility™ Ablation Catheter, Sensor Enabled™ may reduce procedural risk with directed flow and tip temperature monitoring.2-4
- In a comparative in vivo study, the FlexAbility Ablation Catheter, SE demonstrated comparable lesion creation with significantly fewer steam pops.4,5
- A temperature-sensitive thermocouple, located 0.3 mm from the distal tip, may serve as an important indicator for monitoring tip temperature.4
- No instances of charring or coagulum formation were observed during a 179-patient multicenter trial.6
Next-Generation Shaft Technology
The FlexAbility Ablation Catheter, SE combines optimized planarity, torque response and durability.
- A new braid configuration on the proximal region optimizes torqueability.7
- The reconfigured shaft combines:
- Greater curve angles (between 180 and 230 degrees).8,9
- Optimized torque response and deflection force.7-9
- The unidirectional handle option provides better return-to-straight functionality.7-9
- Wire management design maximizes planarity and significantly improves durability.8,9
References
- FlexAbility SE uses the same flexible tip as the FlexAbility Ablation Catheter, which has demonstrated equivalent performance in bench and preclinical testing to the tip used in Therapy Cool Flex.
- Abbott. Data on file. Report 90058001.
- Peichl, P., & Kautzner, J. (2013). Advances in irrigated tip catheter technology for treatment of cardiac arrhythmias. Recent Patents on Cardiovascular Drug Discovery, 8(1), 10-16. https://dx.doi.org/10.2174/1574890111308010003
- Winterfield, J. R., Jensen, J., Gilbert, T., Marchlinski, F., Natale, A., Packer, D., … Wilber, D. J. (2015). Lesion size and safety comparison between the novel flex tip on the FlexAbility ablation catheter and the solid tips on the ThermoCool and ThermoCool SF ablation catheters. Journal of Cardiovascular Electrophysiology, 27(1), 102-109. https://dx.doi.org/10.1111/jce.12835
- As compared to the ThermoCool™ SF catheter (Biosense Webster, Inc.).
- Abbott. Data on file. Report 90125558. Based on Therapy™ Cool Flex™ ablation catheter tip.
- Abbott. Data on file. Report 90115246.
- Abbott. Data on file. Report 90213554.
- As compared to the St. Jude Medical Therapy™ Cool Flex™ ablation catheter.
ThermoCool is a trademark of Biosense Webster, Inc.
MAT-2100522 v1.0
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