CARDIOVASCULAR
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THIS DEVICE IS COMMERCIALLY AVAILABLE FOR USE IN SELECT INTERNATIONAL MARKETS.

DESIGNED IN PARTNERSHIP WITH PHYSICIANS

The FlexAbility™ ablation catheter, with its unique flexible tip and advanced shaft and handle combination, is the Abbott response to the industry need for a predictable, durable cardiac ablation catheter with a strong safety and efficacy profile.1-4 The FlexAbility ablation catheter offers the consistent performance and fatigue-reducing enhancements5,* you need when navigating the most challenging locations, especially during complex, lengthy procedures.

The FlexAbility cardiac ablation catheter offers unique and innovative features—a novel flexible tip and an advanced handle-shaft combination—designed to allow for effective lesion formation with potentially fewer risks,2-4 as well as excellent maneuverability and reduced deflection force.5,*

 

UNIQUE FLEXIBLE TIP

The tip of the FlexAbility ablation catheter may reduce procedural risk with directed flow and tip temperature monitoring.1,3,4

TIP SAFETY DESIGN
  • In a comparative in vivo study, the FlexAbility ablation catheter, demonstrated comparable lesion creation with significantly fewer steam pops.**4
  • A temperature-sensitive thermocouple, located 0.3 mm from the distal tip, serves as an important indicator for monitoring tip temperature.4
  • No instances of charring or coagulum formation were observed during a 179-patient multicenter trial.2
  • Directed irrigation optimizes cooling with flow directed to the tissue.1
ELECTRODE CONFIGURATION
  • One mm distal tip spacing optimizes signal quality.6
NEXT-GENERATION SHAFT TECHNOLOGY

With the FlexAbility ablation catheter, you can navigate anatomy with a catheter designed for accuracy and consistent performance.5 The next-generation shaft technology of the FlexAbility ablation catheter combines optimized planarity, torque response and durability.*5,7

  • Braid configuration on the proximal region optimizes torqueability7
  • Optimized torque response5 and deflection force*5
  • The unidirectional handle option provides better return to-straight functionality.*5,7
  • Wire management design maximizes planarity and significantly improves durability.*5
ADVANCED HANDLE-SHAFT COMBINATION

With the FlexAbility ablation catheter, you can reach challenging locations with less hand fatigue.*5 The handle and shaft of the FlexAbility ablation catheter are designed for comfort and ease of use, offering excellent maneuverability and reduced deflection force.*5

  • A tension-locking mechanism allows for variable device control.
  • The universal actuator design enables deflection independent of the handle position.
  • A novel pull-wire approach is designed to reduce friction, resulting in lower deflection forces.*5
  • The bi-directional handle option offers symmetric and asymmetric curves for additional reach.
COMPREHENSIVE CARDIAC ABLATION THERAPY AND ARRHYTHMIA MANAGEMENT

The FlexAbility ablation catheter is one of our featured electrophysiology products. 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)

REFERENCES

The FlexAbility ablation catheter tip has demonstrated equivalent performance in bench and pre-clinical testing to the tip used in the Therapy™ Cool Flex™ ablation catheter.
*As compared to the Therapy™ Cool Flex™ ablation 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.
4. 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.
5. Abbott. Data on file. Report 90168493.
6. Abbott. Data on file. Report 90139188.
7. Abbott. Data on file. Report 90115246.

A UNIQUE AND EFFECTIVE TIP
  • The tip of the FlexAbility™ ablation catheter offers effective lesion formation with potentially fewer risks.1-3
  • The tight spacing between the tip of the FlexAbility catheter and first band electrode optimizes ECG signal quality.5
  • In a comparative in vivo canine model, the FlexAbility™ ablation catheter had fewer steam pops in comparison to the Biosense ThermoCool SF catheter.2
IN VIVO CANINE STEAM POP TEST RESULTS2
A chart showing the Canine Steam Pop Test Results
  • Lesion formation in an in vivo study showed that the FlexAbility ablation catheter had comparable lesions to ThermoCool and ThermoCool SF.2

In Vivo Study Lesion Results2

In Vivo Study Lesion Results graphic
ZERO CHARRING OR COAGULATION 

A controlled, multicenter trial on the flexible tip used on the Therapy™ Cool Flex™ ablation catheter tip showed zero instances of charring or coagulation in the procedures of 179 patients.3 The flexible tip from the FlexAbility Ablation Catheter has demonstrated equivalent performance in bench and pre-clinical testing to the tip used in Therapy Cool Flex.

MAXIMUM CURVE AND PLANARITY

The FlexAbility ablation catheter maintains better maximum curve and planarity, and exhibits excellent return-to-straight when compared to other uni-directional

catheters.5,6,* 

LOWER ABLATION COSTS

An ablation procedure with Abbott products offers 70 percent lower costs than with cryoablation and 23 percent lower than with Biosense Webster products.a,b,7

COMPREHENSIVE CARDIAC ARRHYTHMIA MANAGEMENT

The FlexAbility ablation catheter is part of our comprehensive cardiac arrhythmia management portfolio.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)

REFERENCES

 

*As compared to the Therapy™ Cool Flex™ ablation catheter.
a. For 70 percent: Using open irrigated-tip catheters, the lowest estimated cost-per-case for manual RF ablation of AF was $6,637 (St. Jude Medical) versus up to $22,284 if focal cryoablation or RF touch-up is needed.
b. For 23 percent: The lowest cost St. Jude Medical™ RF ablation catheter including cables and navigation patches is the Therapy™ Cool Path™ uni-directional catheter costing $2,840, versus the lowest-cost Biosense Webster™ navigation RF ablation catheter with cables and navigation patches, the ThermoCool™ uni-directional catheter costing $3,710.

1. Peichl, P., & Kautzner, J. (2013). Advances in irrigated tip catheter technology for treatment of cardiac arrhythmias. Recent Patents on Cardiovascular Drug Discovery8(1),10-16.http://dx.doi.org/10.2174/1574890111308010003
2. 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.10.1111/jce.12835
3. St. Jude Medical. Data on file, Report 90122753, based on Therapy™ Cool Flex™ ablation catheter tip.
4. St. Jude Medical. Data on file, Report 90139188.
5. St. Jude Medical. Data on file, Report 90168493.
6. St. Jude Medical. Data on file, Report 90115246.
7. Winkle, R. A., Mead, R. H., Engel, G., King, M. H., & Patrawala, R. A. (2013). Physician-controlled costs: The choice of equipment used for atrial fibrillation ablation. Journal of Interventional Cardiac Electrophysiology,36(2), 157-165. http://dx.doi.org/10.1007/s10840-013-9782-x

 

FLEXABILITY™ ABLATION CATHETER

8 F irrigated ablation catheter

SPECIFICATIONS

Model Number

Description

Curve

French Size

Tip Electrode (mm)

Electrode Spacing (mm)

Length (cm)

A701124

Bi-D Irrigated Ablation Catheter (4-hole)

D-D

8

4

1-4-1

115

A701125

Bi-D Irrigated Ablation Catheter (4-hole)

D-F

8

4

1-4-1

115

A701127

Bi-D Irrigated Ablation Catheter (4-hole)

F-F

8

4

1-4-1

115

A701128

Bi-D Irrigated Ablation Catheter (4-hole)

F-J

8

4

1-4-1

115

A701129

Bi-D Irrigated Ablation Catheter (4-hole)

J-J

8

4

1-4-1

115

A701157

Uni-D Irrigated Ablation Catheter (4-hole)

D

8

4

1-4-1

115

A701158

Uni-D Irrigated Ablation Catheter (4-hole)

F

8

4

1-4-1

115

A701159

Uni-D Irrigated Ablation Catheter (4-hole)

J

8

4

1-4-1

115

INDICATIONS, SAFETY & WARNINGS
INDICATIONS, SAFETY & WARNINGS

CAUTION: This product is intended for use by or under the direction of a physician.  Prior to use, reference Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

 

SJM-CV WEB-0718-0025a(2)

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.