FDAnews Device Daily Bulletin

ELANA RECEIVES CE MARK FOR LASER-ASSISTED NEUROVASCULAR SURGERY TECHNIQUE

Nov. 3, 2005
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Elana has obtained CE mark registration for its laser-assisted neurovascular surgery technique that incorporates an excimer laser and a laser catheter manufactured by Spectranetics.

The ELANA (Excimer Laser-Assisted Non-occlusive Anastomosis) technique enables surgeons to create a vascular bypass without occluding the recipient vessel, allowing continued blood supply during the procedure. To make the connection for the bypass graft (anastomosis), a platinum implant is attached to the outside wall of the recipient vessel. The end of the bypass graft then is stitched to the wall of the recipient vessel, using the implant as a guide. Next, a laser catheter is inserted through the bypass graft to the wall of the recipient vessel, and laser ablation is used to create a hole in the artery wall; the laser catheter removes the disc, enabling blood flow to the recipient vessel.

Spectranetics and Elana, a private company based in the Netherlands, announced their development agreements in October 2004. The agreements provide for Spectranetics to supply laser systems and to develop and supply laser catheters. A cross-licensing arrangement of certain of each company's intellectual property rights also is a part of the agreements.