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.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Indication: The Agilis HisPro™ is indicated to provide a pathway for delivery and support of transvenous devices within the chambers and vasculature of the heart and can be used for electrogram recording and stimulation.
Contraindications: Crossing a mechanical tricuspid valve with this device is contraindicated.
Potential Adverse Events: As with any catheterization procedure, potential complications include thromboembolism, local and systemic infection, bleeding or hematoma at the puncture site, vascular dissection or perforation, cardiac perforation, and cardiac tamponade.
MAT-2012811 v2.0
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