Receives FDA-Approval for ProDisc®-C
West Chester, PA (USA), December 18, 2007
Synthes (SWX: SYST.VX) is pleased to announce that the US FDA (Food
and Drug Administration) has fully approved the ProDisc®-C
Total Disc Replacement for commercial sale and distribution in
the United States.
This decision follows the FDA's issuance of an Approvable Letter
for ProDisc-C in October 2007 (see Media Release dated October
25, 2007). The clinical review had been completed at that time.
The remaining review of the associated manufacturing processes
has now also been concluded and the FDA has determined that the
respective requirements of the Quality System Regulations are fulfilled.
ProDisc-C has already been approved and used in Europe and other
areas outside the US.
"We are very proud to be the first company to offer both
a lumbar as well as a cervical artificial disc replacement on the
US market; it will help to treat more patients with a physiological
product in an important area of spinal disc degeneration. Furthermore,
it will help Synthes to strengthen our market position in the segment
of spinal motion preservation", says Michel Orsinger, President
and CEO of Synthes.
Synthes will start with training of surgeons and a controlled
roll-out of the product in January 2008.
The ProDisc-C Total Disc Replacement procedure is intended to
significantly reduce pain caused by cervical disc degeneration.
This is done by allowing for the removal of the diseased disc while
restoring disc height and providing the potential for motion at
the affected vertebral segment.
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
and its soft tissues.
information please contact:
Gilgian Eisner, Investor Relations, Synthes, Inc.
Phone +41 32 720
47 45, Fax +41 32 720 48 11,