Who is a potential candidate for an Artificial Lumbar Disc Replacement?
The CHARITÉ® Artificial Disc is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than 3mm of spondylolisthesis at the involved level. Patients receiving the CHARITÉ® Artificial Disc should have failed at least six months of conservative treatment prior to implantation of the CHARITÉ® Artificial Disc. How many levels can be done with the CHARITÉ® Artificial Disc? The IDE study focused on single level DDD at L4-5 or L5-S1. This is the FDA approved indication within the U.S. How many sizes are available? The CHARITÉ® Artificial Disc endplate is available in four footprint sizes, and an additional four lordotic angle options (0, 5, 7.5, and 10), in conjunction with five sliding core heights (7.5mm through 11.5mm). What has been the clinical experience ar