News | December 21, 1999

Spinal Fusion Surgery Device Receives FDA Approval

The FDA has granted OrthoLogic Corp. (Tempe, AZ) approval for the Pre-Market Supplement of its SpinaLogic device.

The product is used as an adjunct to spinal fusion surgery to improve the probability of a successful fusion. It's a noninvasive, externally worn device that delivers a magnetic signal to the surgical site. SpinaLogic weighs less than two pounds and requires a 30-minute daily treatment cycle.

The product has undergone a randomized double-blind clinical trial in which 240 patients received lumbar spinal fusion.

Thomas Trotter, OrthoLogic's president and CEO, said that the initial product launch will be in the U.S., "where we intend to use a combination of our own direct sales organization coupled with several major regional spine product distributors."

OrthoLogic manufactures orthopedic devices to promote the healing of musculoskelatal tissue.

Edited by Andrea King