FlexAbility Ablation Catheter, Sensor Enabled

FlexAbility Ablation Catheter, Sensor Enabled

About

About FlexAbility Ablation Catheter, Sensor Enabled

Abbott has partnered with physicians worldwide to address the need for an effective, reliable and comfortable irrigated ablation catheter. The FlexAbility™ Ablation Catheter, Sensor Enabled™ fulfills this need by offering a shaft and handle combination with a strong safety and effectiveness profile.^1-4,5 This ablation catheter also integrates with Abbott mapping and navigation systems—including the EnSite Precision™ cardiac mapping system.

The FlexAbility Ablation Catheter, Sensor Enabled, is designed to:

Facilitate detailed, accurate model creation⁶ and effective lesion creation.²
Yield safe, effective outcomes for your patients^1-4
Provide consistent performance and fatigue-reducing enhancements^7,*
Reduce the possibility of procedural risk with directed flow and tip temperature monitoring^1,3,4,5
Provide excellent maneuverability and reduced deflection force.^7,*

FlexAbility Ablation Catheter, Sensor Enabled Product Information

Indications

The FlexAbility Ablation Catheter, Sensor Enabled, is intended for use with the compatible irrigation pump and a compatible RF cardiac ablation generator. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the treatment of typical atrial flutter.

Contraindications

In patients with active systemic infection. In patients with intracardiac mural thrombus or those who have had a ventriculotomy or atriotomy within the preceding four weeks.

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FlexAbility Ablation Catheter, Sensor Enabled Clinical Evidence

Recent journal articles, abstracts and other clinical evidence have analyzed the of the flexible tip design and shaft technology of the FlexAbility Ablation Catheter, Sensor Enabled. For a deep dive into the clinical data, visit the Clinical Evidence and Journal Article information.

Highlights from Tip and Shaft Evidence

The flexible tip design of the FlexAbility Ablation Catheter, Sensor Enabled, may reduce procedural risk with directed flow and tip temperature monitoring.^1,3,4
The shaft technology of the FlexAbility Ablation Catheter, Sensor Enabled, offers optimized torqueability,⁸ greater curve angles,^7,* better return-to-straight functionality^7,8,* and durability.^7,*

Manuals & Resources

Customer Service

This device is commercially available for use in select international markets.

References

*As compared to the St. Jude Medical™ Therapy™ Cool Flex™ ablation catheter.

Abbott. Data on file. Report 90058001.
Abbott. Data on file. Report 90125558. Based on Therapy™ Cool Flex™ ablation catheter tip.
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
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 90213470.
Abbott. Data on file. Report 90213554.
Abbott. Data on file. Report 90115246.

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Information contained herein for distribution outside the U.S. only.

CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

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