Synthes receives an “Approvable Letter” from the United States Food and Drug Administration (FDA) regarding the ProDisc-L Lumbar Total Disc Replacement
Solothurn/Switzerland, January 09, 2006Synthes is pleased to announce that it has received an “Approvable Letter” from the United States Food and Drug Administration (FDA) regarding the ProDisc-L Total Disc Replacement premarket approval application (PMA). The letter, dated January 5, 2006 means that the FDA has concluded its review of the ProDisc-L PMA and has determined that the device is safe and effective for use in treating Degenerative Disc Disease in the lumbar spine at a single level from L3-S1.
FDA has determined that the Prodisc-L Total Disc Replacement PMA is approvable subject to an FDA inspection that finds the manufacturing facilities, methods and controls in compliance with the applicable requirements of the Quality System Regulations (21 CFR Part 820).
FDA will issue an approval order after the inspectional findings have been reviewed and determined to be acceptable. Commercial distribution of the ProDisc-L Total Disc Replacement may not begin until Synthes has received an approval order.
FDA's decision included a review of the results of a human clinical trial of the ProDisc-L conducted over the course of four years. The study involved 292 patients at 17 clinical sites and compared ProDisc-L to circumferential fusion. Patients were evaluated for pain and disability, neurologic status and the maintenance or improvement of flexion-extension/range of motion at the index level. Patients were followed for two years post surgery.
Synthes: A leading medical device company
Synthes is a leading global medical device company. We develop, produce and market instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the human skeleton and its soft tissues.
For further information please contact
Peter Fehlmann, Investor Relations, Synthes, Inc.
Phone: +41 32 720 48 10 , Fax: +41 32 720 48 11
e-mail: ir.info@synthes.com