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Frequently Asked
Questions
Who is a potential candidate for an Artificial Lumbar Disc
Replacement?
How many levels can be done with the CHARITÉ® Artificial
Disc?
How many sizes are available?
What has been the clinical experience around the world?
How long will the disc last?
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 (0º, 5º, 7.5º, and 10º), in conjunction with five sliding core heights (7.5mm through 11.5mm).
What has been the clinical
experience around the world?
The CHARITÉ® Artificial disc has been available for over 17 years in over 30 countries, and the overall results have been positive and appear to provide the intended benefits.
How long will the disc last?
Many implants have been functioning properly for over 17 years in-vivo. Biomechanical bench top testing of 10 million cycles has demonstrated a potential life expectancy equivalent to eighty years, assuming an average of 125,000 significant bends each year. However, as with any implant, patient activity levels and life style can have a possible impact of the actual results.
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