ProDisc Moves One Step Closer to US Launch
BY DAVID KRESSEL, JANUARY 9, 2006
Synthes announced that the FDA sent it an "approvable letter" for the ProDisc-L. The device was deemed safe and effective for treating degenerative disc disease (DDD) at a single level in the lumbar spine, from L3-S1. The FDA expects to approve the PMA after it inspects Synthes' manufacturing facilities and processes.
ProDisc would become the second commercially available total disc replacement device in the US. The first, J&J's Charite has not been warmly received by either physicians or payors. Synthes, patients, and investors are hopeful that the ProDisc will be more successful. We are eager to see how the market responds to this device, because two unsuccessful total disc replacement devices might call into question the whole idea of TDR, particularly in the lumbar region.
