Elana Surical Kit HUDThe Elana Sutrgical Kit HUD contains: The Elana Laser Catheter 2.0, The Elana Rings 2.6&2.8 and a vacuum extension tube.The Elana Surgical Kit HUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.
An assembly of sterile devices designed to create an opening between a blood vessel and a vascular graft (native or synthetic) during a vascular surgical procedure [e.g., coronary artery bypass grafting (CABG), or arteriovenous fistula (AVF) grafting]. It typically includes a delivery tool loaded with metallic clips/connectors/couplers (e.g., surgical stainless steel). A blood vessel graft is loaded into the delivery tool, and upon manual actuation of the tool, the fastening devices are deployed through the graft and into the target vessel, and the tool creates an opening in the target vessel (e.g., aortotomy, arteriotomy). This is a single-use device.