Spinal Implant for Lumbar Fusion Okay’ed
The Lucent Spinal Implant (IBFD), manufactured by Spinal Elements, Incorporated, received marketing approval from the Food and Drug Administration. The device is for lumbar intervertebral body fusion and indicated for patients with degenerative disc disease or other spinal problems. This is the first device approved by the FDA for this indication, as described on the Healthcare Sales and Marketing Network.
The Lucent IBFD is manufactured from PEEK-OPTIMA polymer. This material provides for superior visibility of the implanted device with radiography. The Lucent can be implanted with either a transforaminal or direct posterior approach to access the lumbar space, with separate implants depending on the chosen surgical approach.
The implants have a tapered bullet nose to foster insertion within the lumbar disc space as well as patented graft space features. Devices to be implanted using a transforaminal approach are 10 mm wide and range in size, by one millimeter from 7 to 14 mm.
The devices for direct posterior approaches are available in widths of 8 and 10 mm, heights available are the same as those for the transforminal use implants. Two options available include a convex-lordose and a convex-parallel option.
Each of the devices comes with its own set of tools for use during the insertion procedure. The Lucent instrumentation system uses a color-coded system to promote safety during surgery.
November 28, 2007 Related topics: Product Launches, Product Approval & Certification, Surgery, Orthopedic