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IMPROVE PROCEDURAL EFFICIENCY WITH MANEUVERABILITY AND STABILITY

The Agilis™ NxT steerable introducer is the world’s leading steerable introducer, providing outstanding agility and stability during catheter access and positioning.1 Used in more than 400,000 procedures, the Agilis NxT introducer is the introducer of choice for a growing number of physicians.

Whether seeking to improve catheter navigation for procedural efficacy in cavotricuspid isthmus ablation or reviewing guiding introducers that can assist you during left-sided ablation procedures, you will find that the Agilis NxT introducer is the gold standard for your steerable introducer needs.2,3

REACH HARD-TO-ACCESS AREAS OF THE HEART

The Agilis NxT introducer is designed to replace a fixed curve introducer. It helps you reach hard-to-access areas of the heart, by providing a stable platform for improved catheter manipulation and contact. The Agilis NxT introducer's steerable sheath tip can be adjusted to aid various anatomic approaches — with just one introducer.4

EXPERIENCE THE AGILITY AND STABILITY YOU NEED

The Agilis NxT steerable introducer combines a low profile with high-tech capabilities, giving you greater control during electrophysiology (EP) procedures.Indicated for introducing various cardiovascular catheters into the heart, the Agilis introducer's steerable sheath improves access to hard-to-reach sites (including the left side of the heart through the interatrial septum), eliminating the need to change out sheaths in order to reach the desired position.6

Its atraumatic tip reduces the potential for trauma during transseptal punctures, while facilitating passage of a wide variety of catheters. The Agilis NxT introducer also offers:

  • Steerable sheath, which offers outstanding agility, stability and versatility1
  • Multiple curve choices, including small (16.8 mm), medium (22.4 mm) and large (50.0 mm) curl options
  • Low-profile outer diameter and a large 8.5 F inner lumen, to facilitate passage of a wide variety of catheters
INNOVATIVE KEY FEATURES
  • Dual-Reach™ bi-directional 180˚/90˚ deflection allows asymmetric deflection — for more mobility with less shaft torque.
  • Curl options include small (16.8 mm), medium (22.4 mm) and large (50.0 mm).
  • Auto-lock capability is designed to reduce curve movements during complex procedures.7
  • Braided shaft provides exceptional torquability, pushability and kink resistance.
  • Radiopaque tip marker enhances fluoro visibility.
  • Ultimum™ hemostasis valve provides effective hemostasis, and seals down to a 0.014 inch guidewire.
  • Accommodates a 98 cm BRK™ transseptal needle and BRK-1™ transseptal needle.
  • Ergonomic handle provides user comfort.
COMPREHENSIVE CARDIAC ARRHYTHMIA MANAGEMENT

The Agilis™ NxT steerable introducer 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

Reimbursement Information

REFERENCES

All statements related to improvements in catheter manipulation, control and access are based on the steerable design of Agilis and are in comparison to a fixed curve, non-steerable sheath.

1. St. Jude Medical. Data on file, Agilis NxT Steerable Introducer Claims Matrix, Document # 90119641. World's leading steerable introducer claim based on IMS EP Q1 18 Market Share data.
2. Matsuo, S., Yamane, T., Tokuda, M., Date. T., Hioki, M., Narui, R., … Yoshimura, M. (2012). Prospective randomized comparison of a steerable versus a non-steerable sheath for typical atrial flutter ablation. Europace, 12(3), 402-9. http://dx.doi.org/ 10.1093/europace/eup434 
3. St. Jude Medical. Data on file, Agilis NxT Steerable Introducer IFU, Document # 9003445.
4. Piorkowski, C., Eitel, C., Rolf, S., Bode, K., Sommer, P., Gaspar, T., . . . Hindricks, G. (2011). Steerable Versus Nonsteerable Sheath Technology in Atrial Fibrillation Ablation: A Prospective, Randomized Study. Circulation: Arrhythmia and Electrophysiology, 4(2), 157-165. (Study supported by a research grant from Abbott.) http://dx.doi.org/10.1161/CIRCEP.110.957761
5. Piorkowski, C., Kottkamp, H., Gerds-Li, J., Arya, A., Sommer, P., Dagres, N., . . . Hindricks, G. (2008). Steerable Sheath Catheter Navigation for Ablation of Atrial Fibrillation: A Case-Control Study. Pacing and Clinical Electrophysiology, 31(7), 863-873. http://dx.doi.org/10.1111/j.1540-8159.2008.01101.x
6. Masuda, M., Fujita, M., Iida, O., Okamoto, S., Ishihara, T., Nanto, K., . . . Uematsu, M. (2016). Steerable versus non-steerable sheaths during pulmonary vein isolation: Impact of left atrial enlargement on the catheter–tissue contact force. Journal of Interventional Cardiac Electrophysiology, 47(1), 99-107. http://doi.org/10.1007/s10840-016-0135-4
7. Abbott. Data on file. Report 90130988

EXPERIENCE THE PROVEN SOLUTION

The Agilis™ NxT introducer's steerable sheath promotes improved contact force (CF) parameters during pulmonary vein isolation. In a study conducted by the Keio University School of Medicine, Tokyo, Japan, the average CF was significantly higher when using the Agilis™ sheaths compared to the Swartz™ sheaths, especially in the inferior/anterior wall of the RPV and the roof/calina of the LPV.7 The Agilis NxT introducer improves access to hard-to-reach sites, and can be adjusted to aid various anatomic approaches—eliminating the need to change out sheaths in order to reach the desired position.1 Its soft, atraumatic tip reduces potential for trauma during transseptal punctures, and provides a smooth transition to catheter.

CLINICAL FINDINGS

In clinical studies, the use of the AgilisTM NxT steerable introducer was associated with:

  • Higher rates of complete pulmonary vein isolation at 6 months5
  • Higher rate of freedom from atrial fibrillation (AF) at 6 months2,5 
  • Significantly higher single procedure success rate post-AF ablation2
  • Lower rates of post-op cardioversion after AF ablation5
  • Less use of antiarrhythmic medications post-6 months AF ablation5
  • Fewer reablation for symptomatic drug refractory recurrances5 
  • Reduction in procedure time during CTI ablation6
  • Lower fluoroscopy time during AF ablation2
  • Less total radio frequency (RF) energy delivery during CTI and AF ablation5,6
  • Reduction in RF delivery time during CTI ablation6
  • Higher average contact force in AF ablation4

Learn more about the TOCCASTAR clinical study.

THE AGILIS TM NXT STEERABLE INTRODUCER GETS RESULTS

In a randomized study of steerable versus non-steerable sheath technology in AF ablation, significantly higher single-procedure success was achieved when the ablation catheter was supported by the Agilis NxT steerable introducer, versus a fixed guiding introducer.2

Steerable Versus Non-Steerable Sheath Technology in AF Ablation: Data from a Prospective, Randomized Study2

78% versus 55% after 3 months; 76% versus 53% after 6 months

Studies also found that procedural efficacy was improved during cavotricuspid isthmus ablation when the ablation catheter* was supported by the Agilis NxT steerable introducer, versus a fixed guiding introducer.6

Prospective Randomized Comparison of a Steerable Versus a Non-Steerable Sheath for Typical Atrial Flutter Ablation6

53% reduction in RF energy delivery; 32% reduction in procedure time; 55% reduction in RF energy delivery
COMPREHENSIVE CARDIAC ARRHYTHMIA MANAGEMENT

The Agilis™ NxT steerable introducer 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

Reimbursement Information

REFERENCES

*Ablation catheter used in conjunction with the Agilis NxT steerable introducer: Boston Scientific BlazerTM II XP, 8 mm tip.
1. Masuda, M., Fujita, M., Iida, O., Okamoto, S., Ishihara, T., Nanto, K., . . . Uematsu, M. (2016). Steerable versus non-steerable sheaths during pulmonary vein isolation: Impact of left atrial enlargement on the catheter–tissue contact force. Journal of Interventional Cardiac Electrophysiology, 47(1), 99-107. http://dx.doi.org/10.1007/s10840-016-0135-4

2. Piorkowski, C., Eite,l C., Rolf, S., Bode, K., Sommer, P., Gaspar, T., … Hindricks, G.(2011). Steerable versus non-steerable sheath technology in AF ablation: A prospective, randomized study. Circulation, 4(2), 157-65. http://dx.doi.org/10.1161/CIRCEP.110.957761

3. Cuoco F. (2014, May). Steerable sheath promotes improved contact force parameters during pulmonary vein isolation. Medical University of South Carolina. Presented at the meeting of the Heart Rhythm Society, San Francisco, CA.

4. Mansour, M. (2014, May). TOCCASTAR: Preliminary results of the first prospective randomized study of a contact force sensing ablation catheter for the treatment of paroxysmal AF. Presented at the meeting of the Heart Rhythm Society, San Francisco, CA.

5. Piorkowski, C., Kottkamp, H., Gerds-Li, J. H., Arya, A., Sommers, P., Dagres, N., Hindricks, G. (2008). Steerable sheath catheter navigation for ablation of atrial fibrillation: A case-control study. Pacing and Clinical Electrophysiology, 31(7), 863-873. http://dx.doi.org/10.1111/j.1540-8159.2008.01101.x

6. Matsuo, S., Yamane, T., Tokuda, M., Date. T., Hioki, M., Narui, R., … Yoshimura, M. (2012). Prospective randomized comparison of a steerable versus a non-steerable sheath for typical atrial flutter ablation. Europace, 12(3), 402-9. http://dx.doi.org/10.1093/europace/eup434

7. Kimura, T., Takatsuki, S., Oishi, A., Negishi, M., Kashimura, S., Katsumata, Y., . . . Fukuda, K. (2014). Operator-blinded contact force monitoring during pulmonary vein isolation using conventional and steerable sheaths. International Journal of Cardiology, 177(3), 970-976. http://dx.doi.org/10.1016/j.ijcard.2014.09.189

AGILIS™ NXT STEERABLE INTRODUCERS

Dual-Reach™
61 cm Sheath
8.5 F

Contents: 8.5 F Agilis™ NxT Steerable Introducer with Tip Marker; 81 cm Lumen Length, 61 cm Usable Length, Dilator and 180 cm Super Stiff Guidewire with Finger Straightenable 3 mm "J" (1 unit per box)

ORDERING INFORMATION

Reorder Number

 

 

 

Curl Dimension

 

 

 

Sheath French Size

 

Dilator French Size

 

Maximum Guidewire Diameter (in)

Curve Type

Sheath Usable Length (cm)

G408318

 

16.8 mm

 

8.5

 

8.5

 

.032

 

Small Curl
Dual-Reach™
Bi-directional

61

 

G408319

22.4 mm

8.5

8.5

.032

Medium Curl
Dual-Reach™
Bi-directional

61

SEE FULL PRODUCT DETAILS and any references for this product.

AGILIS™ NXT STEERABLE INTRODUCERS

Dual-Reach™
71 cm Sheath
8.5 F

Contents: 8.5 F Agilis™ NxT Steerable Introducer w/Tip Marker; 91 cm Lumen Length, 71 cm Usable Length, Dilator and 180 cm Super Stiff Guidewire with Finger Straightenable 3 mm "J" (1 unit per box)

ORDERING INFORMATION

Reorder Number

Curl Dimension

Sheath French Size

Dilator French Size

Maximum Guidewire Diameter (in)

Curve Type

Sheath Usable Length (cm)

408309

16.8 mm

8.5

8.5

.032

Small Curl

71

G408320

16.8 mm

8.5

8.5

.032

Small Curl Dual-Reach™ Bi-directional

71

408310

22.4 mm

8.5

8.5

.032

Medium Curl

71

G408321

22.4 mm

8.5

8.5

.032

Medium Curl Dual-Reach™ Bi-directional

71

G408324

50.0 mm

8.5

8.5

.032

Large Curl
Dual-Reach™
Bi-directional

71

SEE FULL PRODUCT DETAILS

AGILIS™ NXT STEERABLE INTRODUCER

Dual-Reach™
82 cm Sheath
8.5 F

8.5 F Agilis™ NxT Steerable Introducer w/Tip Marker; 102 cm Lumen Length, 82 cm Usable Length, Dilator, 180 cm Super Stiff Guidewire with Finger Straightenable 3 mm “J” (1 unit per box)

ORDERING INFORMATION

Reorder Number

Curl Dimension

Sheath French Size

Dilator French Size

Maximum Guidewire Diameter (in)

Curve Type

Sheath Usable Length (cm)

G408332

50.0 mm

8.5

8.5

.032

Large Curl Dual-Reach™ Bi-directional

82

SEE FULL PRODUCT DETAILS and any references for this product.

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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.

Agilis™ NxT Steerable Introducer, all models except for 40cm

Indications: The Agilis™ NxT Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. 

Contraindications: The Agilis™ NxT Steerable Introducer is contraindicated for previous intra-atrial septal patch, Known or suspected atrial myxoma, Myocardial Infarctions within the last two weeks, Unstable angina, Recent Cerebral Vascular Accident (CVA), Patients who do not tolerate anticoagulation therapy, Patients with an active infection, and Presence of atrial thrombus. 

Warnings: Do not alter this device in any way. Only those physicians who are trained in transseptal procedures and SJM catheter delivery systems should use this device. Do Not reuse this device. Thorough cleaning of biological and foreign material is not possible. Adverse patient reactions may result from reuse of this device. Maintain continuous hemodynamic monitoring throughout procedure. Always observe acceptable hemodynamics prior to advancing the dilator or any other component. Always withdraw components/aspirate slowly to minimize the vacuum created during withdrawal. From the sideport only – aspirate all air prior to fluid infusion. Provide continuous heparinized saline infusion while the introducer remains in the vessel. Fibrin may accumulate in or on the sheath tip during the procedure. To prevent dislodgment of potential thrombus, aspirate when removing dilator or catheter. Prior to removing the steerable introducer, reinsert the guidewire through the introducer, reintroduce the dilator over the guidewire, straighten the steerable introducer, then remove the dilator, guidewire, and introducer as a unit. Maximum in-vivo time: 7 hours. 

Precautions: US federal law restricts this device to sale by or on the order of a physician. Carefully read instructions before use of device to help reduce potential risks and complications associated with transseptal procedures, such as air emboli and/or perforation of the aorta and left atrium (LA). (Perforation of the aorta and LA not included for 82 cm device). Inspect all components before use. Do not use if package or items in kit appear to be damaged or defective. The French size specified represents the inner diameter of the introducer sheath. 

Potential adverse events: Cardiac perforation, Embolus, Cerebrovascular accident, Death, Atrial fibrillation, Dissection and Heart block.

Agilis™ NxT Steerable Introducer, 40cm

Indications: The Agilis™ NxT Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart. 

Contraindications: The Agilis™ NxT Steerable Introducer is contraindicated for known or suspected atrial myxoma, Myocardial Infarctions within the last two weeks, Unstable angina, Recent Cerebral Vascular Accident (CVA), Patients who do not tolerate anticoagulation therapy, Patients with an active infection and Presence of atrial thrombus. 

Warnings: Do not alter this device in any way. Only those physicians who are trained in transseptal procedures and SJM catheter delivery systems should use this device. Do Not reuse this device. Thorough cleaning of biological and foreign material is not possible. Adverse patient reactions may result from reuse of this device. Maintain continuous hemodynamic monitoring throughout procedure. Always observe acceptable hemodynamics prior to advancing the dilator or any other component.  

Precautions: US federal law restricts this device to sale by or on the order of a physician. Carefully read instructions before use of device to help reduce potential risks and complications associated with transseptal procedures, such as air emboli and/or perforation of the aorta and left atrium (LA). (Perforation of the aorta and LA not included for 82 cm device). Inspect all components before use. Do not use if package or items in kit appear to be damaged or defective. The French size specified represents the inner diameter of the introducer sheath. 

Potential adverse events: Cardiac perforation, Embolus, Cerebrovascular accident, Death, Atrial fibrillation, Dissection and Heart block.

Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

 

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