||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.
||Arteriotomy SystemHUD and extension tubing for connection to a vacuum source. It is comprised of the catheter and the rings. The Elana Surgical KitHUD should only be used with the US legally marketed Spectranetics XeCl (Xenon-Chloride) Excimer Laser System, Model CVX-300.
||The surgeon attaches the ring with the donor graft to the artery wall using a fine suture. Apply suction. For about 2 minutes the catheter tip should be held in steady contact with the artery wall. After the two minutes, the Excimer laser is activated). A train of pulses is delivered. When 200 pulses are delivered, the laser will stop automatically. The surgeon slowly removes the catheter and checks for a retrograde blood flow through the donor graft before occluding it.
Office of Device Evaluation
Division of Neurological and Physical Medicine Devices
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
HDE - Humanitarian Device Exemption
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
|Third Party Review
||Not Third Party Eligible