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
MAT-2012306 v2.0
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Precautions
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