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
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
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.
*Based on sales through Dec 31, 2020
MAT-2006882 v2.0
Rx Only. Brief Summary: 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.
United States: Required Safety Information
Indications:
The Agilis™ NxT Steerable Introducer is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.
Contraindications:
Warnings:
Precautions:
MAT-2301806 v3.0
The BRK Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
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.
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.
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:
Complications that may occur during use of this device include, but are not limited to:
MAT-2301805 v2.0
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