Raymedica Regains PDN Device Distribution Rights

Raymedica, a manufacturer of nonfusion spinal implants for the treatment of back pain, has announced that Medtronic will return the European and Indian distribution rights of the PDN-SOLO Prosthetic Disc Nucleus to Raymedica.

The PDN device is comprised of a hydrogel material contained within a woven polyethylene jacket. The device is designed to replace the form and function of an otherwise failed spinal disc nucleus. The device is designed to further support the annulus tissue and vertebrae bones of a patient's spine while allowing for more flexibility and movement than spinal fusion, the current established surgical treatment, in which adjacent vertebrae of the spine are fused together.

The PDN-SOLO device is commercially available in Europe and other international markets, but is not yet approved for commercial distribution in the U.S. More than 3,300 patients worldwide have received a PDN implant. Raymedica is pursuing marketing approval from the FDA. A new distribution network will be established to actively market the PDN-SOLO device during the second quarter of 2005.