FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Elana Surgical KitHUD
Manufacturer: Elana bv
Address: Yalelaan 44, 3584 CM, Utrecht, The Netherlands
Approval Date: March 10, 2011
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf8/h080005a.pdf
What is it? A ring and laser catheter (handpiece), when connected to the Spectranetics XeCl (Xenon-Cloride) Excimer laser system (CVX-300), that allows a neurosurgeon to cut circular openings in an artery in the brain (i.e., perform an intracranial arteriotomy) while blood still flows in the artery.
How does it work? The neurosurgeon sutures the bypass graft and the encircling ring onto an unclamped artery. The neurosurgeon then tunnels the tip of the handpiece down the graft until tip touches the ring. Upon activation, the perimeter of the tip delivers the cutting laser beam while the interior provides suction. Once the circular hole is cut in the artery, the surgeon checks the graft connection (anastomosis) with retrograde blood flow through the donor graft. The neurosurgeon repeats this cutting process on the other side of the aneurysm or tumor, and then sutures the ends of the two graft pieces together to create a bypass.
When is it used? For creating arteriotomies during an intracranial vascular bypass procedure in patients greater than 13 years of age 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.
What will it accomplish? It is intended to allow the neurosurgeon to create a bypass without clamping the intracranial artery.
When should it not be used? A patient should not undergo this laser bypass if the recipient intracranial arteries show signs of arteriosclerosis or calcification at the chosen site, when flow in the recipient artery is interrupted or reduced, on recipient artery types known to have a wall thickness higher than that of a human internal carotid artery or identified to have an abnormality, on an aneurysm, or on vessels other than large intracranial arteries.
Additional Information: Summary of Safety and Probable Benefit and labeling are available online.