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U.S. Department of Health and Human Services

Product Classification

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Device surgical kit
Definition 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.
Physical State 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.
Technical Method 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.
Target Area Neurovascular arteries
Review Panel Neurology
Product CodePAX
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible