Medtronic gets FDA clearance for ZEVO anterior cervical plate system — 5 things to know

Written by Laura Dyrda | May 05, 2015 | Print  |

Medtronic received FDA 510(k) clearance for the ZEVO Anterior Cervical Plate System.

Here are five things to know about the system:

 

1. It is commercially available to treat cervical degenerative disease, trauma, tumors, deformity, pseudoarthrosis and/or failed previous fusions.

 

2. The system includes shorter plating options and hyper screw angulations so surgeons can select the smallest plate possible to secure the plate as far away from the adjacent disc as possible.

 

3. The system has lower-profile plates with minimal thickness — 1.9 mm and 2.1 mm — and increases the stability of the construct for the 4-5 level.

 

4. The risks include early or late loosening of any or all components and developing new radiculopathy, myelopathy or pain and/or tissue or nerve damage caused by improper positioning and implant or instrument placement.

 

5. Literature shows this technique could lower the overall adjacent level ossification development in patients.

 

"Improved, thinner plates are important in ACDF procedures," said Richard Hynes, MD, a spine surgeon at The B.A.C.K. Center in Melbourne, Fla. "ZEVO embodies these characters with the added benefits of hyper screw angulations, which can be directed away from the spinal cord."

 

More articles on orthopedic devices:
NuVasive launches alignment-focused spine system—5 things to know
New Nexxt Spine anterior cervical plate released on the full market—5 things to know
Zimmer, Implanet, NuVasive & more—19 key notes

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