Medtronic's Prestige LP Disc vs. 2-level ACDF: 5 insights on 7-year outcomes

Written by Anuja Vaidya | May 04, 2016 | Print  |

Medtronic released results of a seven-year follow-up study in which the two-level Prestige LP Cervical Disc was compared to 2-level anterior cervical discectomy and fusion.

The Prestige LP Disc is currently indicated for single-level cervical disc disease causing nerve or spinal cord compression from C3-C7. The disc doesn't have pre-market approval from the FDA for two-level use. The disc has a ball-and-trough design and moves in a range of motions.

 

Here are five insights:

 

1. The 2-level Prestige LP Disc patients showed greater rates in overall success — 78.6 percent — compared to the patients treated with 2-level ACDF — 62.7 percent. Overall success, an FDA requirement during clinical trials, includes four measurements:

 

•    Neurological success
•    Neck disability index improvement of 15 points  
•    Rate of secondary surgeries
•    Adverse events  

 

2. The Prestige disc patients showed a neurological success rate of 91.6 percent compared to the patients treated with two-level ACDF who saw a neurological success rate of 82.1 percent. Neurological success refers to whether patients have the same or improved neurological states before and after surgery. For example, some patients may come into a surgery with pinched nerves or slight weaknesses/numbness. If the patient has the same or improved rate of neurological activity, it is counted as neurological success.

 

3. The Prestige disc patients exhibited greater success rates in patient-reported outcomes, including Neck Disability Index — 87.0 percent — as compared to the 75.6 success rate that patients treated with two-level ACDF experienced.

 

4. Around 4.2 percent of Prestige patients needed second surgeries at the index levels, whereas 14.7 percent of two-level ACDF patients required the same.

 

5. Adverse event profiles were similar between groups.

 

"This is the longest follow-up data available on clinical study patients treated with two-level cervical arthroplasty in the United States," said Tommy Carls, vice president of research and development for the spine division, which is part of the Restorative Therapies Group at Medtronic.

 

Note: Risks of the Prestige LP Disc include, but are not limited to, bone formation (including heterotopic ossification) that may reduce spinal motion or result in a fusion, either at the treated or at adjacent levels.

 

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