Access and Introducers

Abbott offers access devices that help electrophysiologists and cardiac interventionalists reliably access areas of the heart during ablation and mapping procedures. We design our devices to deliver high maneuverability and enhanced physician control1,2 even during complex electrophysiology (EP) procedures

Agilis™ NxT Steerable Introducer

The Agilis™ NxT Steerable 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. Used in more than 1,000,000 procedures*, the Agilis NxT Steerable Introducer provides outstanding agility and stability during catheter access and positioning.2

BRK™ Transseptal Needles

Experience the consistency, reliability and flexibility of the BRK™ Transseptal Needles—designed for seamless operation. All BRK Transseptal Needles integrate optimally with Abbott guiding introducers.

Manuals & Technical Resources

Cardiovascular Products

Customer Service

*Based on sales through Dec 31, 2020

 

References

  1. 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. https://dx.doi.org/10.1111/j.1540-8159.2008.01101.x
  2. Abbott 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.

MAT-2006882 v2.0

Indications, Safety & Warnings
 

Agilis™ NxT Steerable Introducer

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 Abbott 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:

  • Federal law (U.S.) restricts this device to sale by or on the order of a physician.
  • Carefully reading the Instructions before use of this device will help to reduce the potential risks and complications associated with the transseptal technique such as air emboli and/or perforation of the aorta and left atrium.
  • Inspect all components before use. Do not use if the package or items in the kit appear to be damaged or defective.
  • The French size specified represents the inner diameter of the introducer sheath.
  • Do not attempt to insert a catheter having a distal tip or body size larger than the introducer size indicated.
  • The SJM™ Agilis™NxT steerable introducer is designed to interlock only with SJM™ dilators. Misuse may result in serious complications.
  • Do not attempt to use a guidewire larger than the maximum diameter specified on the package label.
  • Prior to inserting the device into the patient, pre-assemble the steerable introducer and dilator.
  • During insertion, use caution not to create excessive bends in this device.
  • Frequently aspirate and saline flush the sheath to minimize the potential for thrombus formation.
  • Do not remove dilator or catheter rapidly. Damage to the backbleed valve may occur.
  • Do not deflect the device beyond 180◦ prior to insertion of a 8 mm tip electrode catheter.
  • If resistance is met when advancing or withdrawing guidewire or introducer, determine cause and correct before continuing with this procedure.
  • Do not use the introducer without a catheter or dilator supporting the lumen.
  • Use of the introducer directly over a wire without a catheter or dilator supporting the lumen may result in air embolism, which can lead to death.
  • Do not torque or rotate the handle if the distal tip/shaft is constrained.
  • If the shaft is unable to freely rotate, only manipulate the catheter via the articulation knob.
  • Indwelling percutaneous introducers should always be supported with a catheter or dilator.
  • Aspirate slowly, only from the sideport.
  • Inject or saline flush only from the sideport.
  • Certain conditions may require special consideration when using this product. These may be, but are not limited to enlarged aortic root, small left atrium, marked right atrial enlargement, marked distortion of the thorax configuration (i.e. kyphosis or scoliosis).
  • Store in a cool, dark, dry place.
  • This device is intended for one time use only. Do not reprocess or reuse. Reuse can cause patient injury and/or the communication of infectious disease(s) from one patient to another

MAT-2301806 v2.0

BRK™ and BRK™ XS
Transseptal Needles

Indications

The BRK Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
 

Contraindications

The BRK Transseptal Needle (TSN) is contraindicated for Previous interatrial septal patch or prosthetic atrial septal defect closure device, Any previous thromboembolic event, Known or suspected left atrial myxoma, Known or suspected myocardial infarction within the last two weeks, Unstable angina, Recent cerebral vascular accident (CVA), Patients who do not tolerate anticoagulation therapy and Patients with an active infection.
 

Warnings

Do not alter this medical device in any way. Do not reuse this medical device. After use, thorough cleaning of biological and foreign material is not possible. Adverse patient reactions may result from reuse of this medical device.
 

Precautions

The clinical user of BRK TSN is cautioned that their use is restricted to sale by or on the order of a licensed physician. BRK TSNs must be stored in a cool, dark, and dry location. This device is intended for one time use only. Do not reprocess or reuse BRN TSNs. Reuse of BRK TSNs can cause patient injury. For special patient population: Prior to a surgical procedure employing a BRK TSN, the patient must be hemodynamically stable. Certain medical conditions may require special attention when using this medical device. These may include, but are not limited to the following: Rotated heart, Enlarged aortic root, Marked right atrial 0RA) enlargement, Scoliosis (a neuro-muscular condition influenced by other factors, although it appears to be a bone condition) or kyphosis (characterized by an abnormally rounded upper back), Abnormal left atrial (LA) geometry, Congenital cardiac malformations, Vascular malformations and Inability to access the right atrium (RA) via the inferior vena cava (IVC). Concerning procedural considerations: Users (physicians) of BRK TSNs should comply with the following precautions/cautions: Carefully reading the Instructions (IFU) before use of this device will help reduce the potential risks associated with the transseptal catherization technique such as embolism or cardiovascular perforation. Only those physicians who are specially trained in transseptal procedures should use this device. Fluoroscopy should be used to confirm positioning throughout the procedure. Transseptal procedures should be performed only in facilities appropriately equipped and staffed to perform such procedures. Laboratory/clinical facility capabilities should include, but are not limited to, having the following:

  • Intra-cardiac pressure monitoring capabilities.
  • Systemic pressure monitoring capabilities.
  • Contrast media injection and management of untoward reactions to contrast media.
  • Pericardiocentesis (i.e., aspiration of fluid from the pericardial space or sac that surrounds the heart).
  • Surgical backup.
  • Anticoagulation therapy and monitoring.
     

Potential Complications

Complications that may occur during use of this device include, but are not limited to:

  • Air embolism
  • Cardiac perforation
  • Cardiac tamponade
  • Conduction system disturbances such as SA node, AV node, or His-Purkinje system block
  • Hematoma or excessive bleeding at the vascular access site
  • Reaction to contrast medium
  • Stroke
  • Thromboembolism
  • Valvular damage
  • Cardiac arrhythmias

MAT-2301805 v2.0