Medtronic's Prestige LP Cervical Disc receives 2-level FDA approval: 6 things to know

Anuja Vaidya -   Print  |

The FDA cleared Medtronic's Prestige LP Cervical Disc for two-level applications.

Here are six things to know:

 

1. The device is cleared for the treatment cervical disc disease treatment at two adjacent levels between the C3-C7 segments.

 

2. The device is Medtronic's third artificial cervical disc and Medtronic’s first disc determined safe and effective for both one- and two-level procedures. LDR’s Mobi-C is also cleared for two-level disc replacement.

 

3. The device has a low profile and a ball-and-trough design.

 

4. Early in May, Medtronic released results of a seven-year follow-up study in which the two-level Prestige LP Cervical Disc was compared to two-level anterior cervical discectomy and fusion.

 

5. The follow-up study showed that two-level Prestige LP Disc patients showed greater rates in overall success (78.6 percent) compared to the patients treated with two-level ACDF (62.7 percent).

 

6. There are a few risks associated with the device including, but not limited to, the development of new nerve or spinal cord compression or pain.

 

More articles on devices:
Dr. Nicole Ehrhart's preclinical study affirms AlloStem Cellular Bone Allograft effectiveness: 5 key takeaways
Safe Orthopaedics names Pierre Dumouchel CEO: 3 things to know
Aurora Spine receives $1M insider loan: 4 notes

© Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this content? View our policies here.

Featured Webinars

Featured Whitepapers