Synthes receives Approvable Letter from
FDA for ProDisc™-C
(cervical) Total Disc Replacement
Solothurn/Switzerland, October 25, 2007
Synthes announced today that it has received an Approvable Letter
from the U.S. Food and Drug Administration (FDA) regarding the
ProDisc™-C Total Disc Replacement. The Pre-Market Approval
(PMA) request was submitted to the FDA in January 2007.
The letter means that the FDA has concluded its review of the
ProDisc-C PMA and has determined that the device is safe and effective
for use in replacing a diseased and/or degenerated intervertebral
disc of the cervical spine in patients with symptomatic cervical
disc disease (SCDD). The ProDisc-C Total Disc Replacement procedure
is intended to significantly reduce pain by allowing for the removal
of the diseased disc while restoring disc height and providing
the potential for motion at the affected vertebral segment.
FDA has determined that the ProDisc-C is approvable subject to
the satisfaction of applicable requirements of the Quality System
Regulations (21 CFR Part 820).
FDA will issue an approval order after the manufacturing processes
have been reviewed and determined to be acceptable. Commercial
sale and distribution of the ProDisc-C Total Disc Replacement in
the US may not begin until Synthes has received an approval order
The FDA's decision included a review of the results of a human
clinical trial of the ProDisc-C conducted over the course of three-and-a-half
years. The study involved 209 patients at 13 clinical sites and
compared ProDisc-C to Anterior Cervical Discectomy and Fusion (ACDF),
which is the current standard of care.
Patients were evaluated for pain and disability, neurologic status
and range of motion at the index level. Patients were followed
for two years post surgery, and the data supports that ProDisc-C
is a clinically proven alternative to cervical fusion.
The ProDisc-C Total Disc Replacement is a modular implant consisting
of two CoCrMo (cobalt chromium molybdenum) endplates and one
UHMWPE (Ultra High Molecular Weight Polyethylene) inlay. CoCrMo
alloy was used in ProDisc-C Total Disc Replacement for its superior
strength, proven biocompatibility, superior abrasion resistance,
and superior wear characteristics when coupled with UHMWPE.
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.