What is Charite disc implantation?
This surgical procedure replaces a damaged or diseased disc in the lumbar spine with an artificial disc that restores the natural alignment of the spine.
Will Medicare pay for lumbar disc replacement?
Medicare does not currently have a national coverage determination (NCD) on lumbar artificial disc replacement. Coverage for the procedure is overseen by local Medicare contractors. Medicare also does not have a NCD for other spinal surgeries for degenerative disc disease.
Is disc replacement covered by Medicare?
On the national level, cervical artificial disc replacement isn’t covered because Medicare has ruled that the procedure is not medically necessary for people over the age of 60. Some local Medicare carriers have issued additional guidance that allows for coverage of the procedure for certain individuals.
Is the M6 L FDA approved?
The M6-L is not available in the U.S. and there are no plans by Orthofix to initiate an FDA submission or US clinical trial for approval of the M6-L.
How long does Charite artificial disc last?
Charité total disc replacement—clinical and radiographical results after an average follow-up of 17 years.
Are artificial discs FDA approved?
Overview and Indications Currently, the artificial disc replacement is only FDA-approved in the United States for use in the lumbar (low back) region, although many products are currently being studied for use in the cervical (neck) region.
Can L5 S1 disc be replaced?
Devices differ in where they can be implanted. For example, some devices may only be approved for implantation at the L4-L5 or L5-S1 segments, and other lumbar disc implant designs can be implanted anywhere between L3 and S1. Current lumbar devices are approved for use by the FDA only at a single spinal segment.
What is an artificial disc made of?
While there are several different types of artificial discs, most are made of a metal (such as titanium or cobalt chromium) outer shell with an inside made of medical grade plastics. However, all artificial discs share the same purpose: to replace damaged discs while retaining movement and flexibility.
How long will a Mobi-C last?
Zimmer Biomet, the manufacturer of Mobi-C® Artificial Disc says: Every Mobi-C tested in the lab completed 10 million movement cycles, all demonstrating low wear rates.