CARDIOVASCULAR

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DESIGNED IN PARTNERSHIP WITH PHYSICIANS

As a leader in cardiac ablation products, Abbott has partnered with physicians worldwide to address the clinical need for an irrigated ablation catheter that is reliable and comfortable to use. The result is the FlexAbility™ cardiac ablation catheter, Sensor Enabled™.

OVERVIEW

EVIDENCE

TECH SPECS

The flexible tip and advanced shaft and handle combination of the FlexAbility ablation catheter, Sensor Enabled, fulfills the industry’s need for a predictable, durable cardiac ablation catheter with a strong safety and effectiveness profile.^1-4*

Designed to enhance procedural versatility and precision when integrated with Abbott mapping and navigation systems—including the EnSite Precision™ cardiac mapping system —the FlexAbility ablation catheter, Sensor Enabled, was created to facilitate detailed, accurate model creation⁵ and effective lesion creation.²

The FlexAbility ablation catheter, Sensor Enabled, is intended to yield safe, effective outcomes for your patients^1-4 and provide the consistent performance and fatigue-reducing enhancements^6**—important for long procedures.

UNIQUE FLEXIBLE TIP^*

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 tip has demonstrated:

Tip safety: The catheter demonstrated comparable lesion creation with significantly fewer steam pops in an in vivo canine model^****4 and no instances of charring or coagulation formation in a human clinical trial.²
Tip conformance: The flexible tip conforms to the myocardium and reduces operator-transmitted force into the tissue.^***7
Electrode configuration: 1 mm band distal tip spacing optimizes signal quality.⁸

NEXT-GENERATION SHAFT TECHNOLOGY

With the FlexAbility ablation catheter, Sensor Enabled, you can navigate anatomy with a catheter designed for accuracy and consistent performance.^**6 Its next-generation shaft technology combines optimized planarity, torque response and durability.^**6,9

Constructed for control
Durable design

ADVANCED HANDLE-SHAFT COMBINATION

With the FlexAbility ablation catheter, Sensor Enabled, you can reach challenging locations with less hand fatigue.^**6 Its handle and shaft are designed for comfort and ease of use, offering excellent maneuverability and reduced deflection force.^**6

COMPREHENSIVE CARDIAC ABLATION THERAPY AND ARRHYTHMIA MANAGEMENT

We are leading the way with inventive designs that give you the options you need to diagnose, treat and manage arrhythmias with versatility and effectiveness. When it comes to understanding and managing cardiac arrhythmias, we are your partner for life. Read more about our approach to electrophysiology.

RESOURCES AND DOCUMENTATION

Product Manuals (Instructions for Use)

Reimbursement Information

Mediguide^™Technology Clinical Compendium (92.13KB)

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.
**As compared to the St. Jude Medical™ Therapy™ Cool Flex™ ablation catheter.
***As compared to the St. Jude Medical™ Therapy™ Cool Path™ catheter.
****As compared to the ThermoCool™ SF catheter (Biosense Webster, Inc.).
1. Abbott. Data on file. Report 90058001.
2. Abbott. Data on file. Report 90122753. Based on Therapy™ Cool Flex™ ablation catheter tip.
3. 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. http://dx.doi.org/10.2174/1574890111308010003
4. 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. http://dx.doi.org/10.1111/jce.12835
5. Abbott. Data on file. Report 90213470.
6. Abbott. Data on file. Report 90213554.
7. Abbott. Data on file. Report 90042968.
8. Abbott. Data on file. Report 90139188.
9. Abbott. Data on file. Report 90115246.

DESIGNED FOR OPTIMAL PERFORMANCE

EVIDENCE FOR THE UNIQUE AND EFFECTIVE TIP*

The flexible tip design of the FlexAbility™ ablation catheter, Sensor Enabled™, may reduce procedural risk with directed flow and tip temperature monitoring.^1-3

In a comparative in vivo study, the FlexAbility Catheter, Sensor Enabled, demonstrated comparable lesion creation with significantly fewer steam pops.^**3
A temperature-sensitive thermocouple, located 0.3 mm from the distal tip, may serve as an important indicator for monitoring tip temperature.³
No instances of charring or coagulum formation were observed during a 179-patient multicenter trial.⁴

NEXT-GENERATION SHAFT TECHNOLOGY

The next-generation shaft technology of the FlexAbility Ablation Catheter, Sensor Enabled, combines optimized planarity, torque response and durability.

A new braid configuration on the proximal region optimizes torqueability.⁵
The reconfigured shaft combines:
- Greater curve angles (between 180 and 230 degrees).^6***
- Optimized torque response and deflection force.^***5,6
The unidirectional handle option provides better return-to-straight functionality.^***5,6
Wire management design maximizes planarityand significantly improves durability.^***6

COMPREHENSIVE CARDIAC ABLATION THERAPY AND ARRHYTHMIA MANAGEMENT

The FlexAbility ablation catheter, Sensor Enabled, is one of our featured electrophysiology products. We are leading the way with inventive designs that give you the options you need to precisely diagnose, treat and manage arrhythmias with versatility and efficacy. When it comes to understanding and managing cardiac arrhythmias, we are your partner for life. Read more about our approach to electrophysiology.

RESOURCES AND DOCUMENTATION

Product Manuals (Instructions for Use)

Reimbursement Information

*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.
**As compared to the ThermoCool™ SF catheter (Biosense Webster, Inc.).
***As compared to the St. Jude Medical Therapy™ Cool Flex™ ablation catheter.
ThermoCool is a trademark of Biosense Webster, Inc.
1. St. Jude Medical. Data on file, Report 90058001.
2. 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. http://dx.doi.org/10.2174/1574890111308010003
3. Winterfield, J. R., Jensen, J., Gilbert, T., Marchlinski, F., Natale, A., Packer, D., Wilber, D. J. (2016). 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. http://dx.doi: 10.1111/jce.12835
4. St. Jude Medical. Data on file, Report 90122753. Based on Therapy™ Cool Flex™ ablation catheter tip.
5. St. Jude Medical. Data on file, Report 90115246.
6. St. Jude Medical. Data on file, Report 90213554.

FLEXABILITY™ ABLATION CATHETER

Sensor Enabled™

Contents: 8 F irrigated ablation catheter

ORDERING INFORMATION

Sensor Enabled™ Uni-D Irrigated Ablation Catheter

Reorder Number	Description	Curve	French Size	Electrode Spacing (mm)	Tip Electrode (mm)	Length (cm)
A-FASE-DD	Sensor Enabled™ Bi-D Irrigated Ablation Catheter	D-D	8	1-4-1	4	115
A-FASE-DF	Sensor Enabled™ Bi-D Irrigated Ablation Catheter	D-F	8	1-4-1	4	115
A-FASE-FF	Sensor Enabled™ Bi-D Irrigated Ablation Catheter	F-F	8	1-4-1	4	115
A-FASE-FJ	Sensor Enabled™ Bi-D Irrigated Ablation Cathete	F-J	8	1-4-1	4	115
A-FASE-JJ	Sensor Enabled™ Bi-D Irrigated Ablation Catheter	J-J	8	1-4-1	4	115
A-FASE-D	Sensor Enabled™ Uni-D Irrigated Ablation Catheter	D	8	1-4-1	4	115
A-FASE-F	Sensor Enabled™ Uni-D Irrigated Ablation Catheter	F	8	1-4-1	4	115
A-FASE-J	Sensor Enabled™ Uni-D Irrigated Ablation Catheter	J	8	1-4-1	4	115

SEE FULL PRODUCT DETAILS and any references for this product.

Indications, Safety & Warnings

INDICATIONS, SAFETY & WARNINGS

FlexAbility™ Ablation Catheter, Sensor Enabled™

Rx Only

Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

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.

Warnings: Catheter ablation procedures present the potential for significant x-ray exposure. The long-term risk of protracted fluoroscopy has not been established. Careful consideration must be given for the use of the device in prepubescent children and pregnant women. The long terms risks of RF ablation lesions have not been established. The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data. Always verify the tubing and catheter have been properly cleared of air prior to inserting the catheter into the vasculature since entrapped air can cause potential injury or fatality.

Precautions: If the irrigation pump alarm sounds, terminate RF delivery. If impedance rises suddenly that does not exceed the preset limit, power delivery should be manually discontinued. Always maintain constant irrigation to prevent coagulation within and around electrodes. Irrigated ablation systems have been shown to create larger lesions than standard radiofrequency ablation catheters. Care should be taken when ablation near electrically vulnerable, thin-walled or other arterial structures. If irrigation is interrupted, immediately inspect and reflush the catheter outside of the patient. Reestablish irrigation flow prior to placing catheter in the body. Do not attempt ablation without using an irrigation pump.

Potential adverse events: Potential adverse events include, but are not limited to, cardiovascular and anesthesia-related complications, including inadvertent AV block. Please refer to the Instructions for Use of a complete list.

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FLEXABILITY™ IRRIGATED ABLATION CATHETER, SENSOR ENABLED™