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.
*Based on sales through Dec 31, 2020
MAT-2006882 v2.0
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: 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 complications: The following potential complications may occur during the use of this device, but are not limited to: Air embolism, infection, intimal tear, hematoma, perforation, and thrombus formation.
MAT-2301806 v1.0
The BRK Transseptal Needle is used to puncture the interatrial septum during a transseptal 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:
Pericardial Effusion, Cardiac Perforation, Tamponade and Perforation.
MAT-2301805 v1.0
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Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
Precautions
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The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.
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