Synthes PRODISC Receives FDA Approval
BY JOHN MCCORMICK, AUGUST 15, 2006
Yesterday Synthes Spine received a letter from the FDA indicating that its PRODISC lumbar total disc replacement device PMA has been approved.
Typically when a PMA is approved, the FDA attaches conditions and restrictions to use of the device and also outlines the indicatons of the approved device. We provide a brief summary of the indications and restrictions pertaining to PRODISC below.
INDICATIONS
- Skeletally mature patients with DDD
- One level only at: L3-S1
- No more than Grade 1 Spondylolisthesis
- Not responding to conservative treatment
CONDITIONS
- Synthes must conduct a long-term (5yr) safety and effectiveness study for IDE patients
- Synthes must also undertake a second analysis that evaluates "Overall Success"
- Synthes must undertake a yearly analysis of adverse events
- Results of these studies to be reflected in suppementary labeling
Readers may wish to dial-in to tomorrow's (Weds Aug 16) investor conference call that Synthes is holding at 8:30am(EST). Call information is provided here:
LIVE (Weds 8:30am EST)
US: 1.866.291.4166
OUS: 44.20.7107.0611
Replay (Aug 16 - Aug 18)
US: 1.866.416.2558
OUS: 44.20.7108.6233
Access Code 263#
