Seven-year clinical efficacy and patient satisfaction data for patients with double-segment Prestige LP cervical disc system

Release date: 2016-05-25

The latest study found that patients with a two-segment Prestige LP cervical disc system had better clinical outcomes and patient satisfaction, including long-term US double-segment cervical disc patient data.

DUBLIN – May 24 – Medtronic recently announced that seven-year clinical data indicate that Medtronic's double-segment Prestige LP neck is comparable to double-segment cervical anterior discectomy for interbody fusion (ACDF). The intervertebral disc system gives patients better clinical results and satisfaction. The Medtronic Prestige LP system is now only used for single-segment cervical disc disease (neural root and/or spinal cord compression) in the C3-C7 vertebral body, and Medtronic is also awaiting FDA approval for its use in double-segment cervical disc disease. Unlike fusion, the device allows the patient's cervical spine to maintain mobility. The Prestige LP cervical disc system is the third clinically proven cervical disc in Medtronic's line of products. It is designed with a ball slot that allows for a degree of mobility, including bending, rotation and translation.

The data was presented at the High-Tech Session of the 84th Annual Meeting of the American Association of Neurological Surgeons (AANS) in Chicago, presented by Dr. Todd Ranman, a neurosurgeon at the Los Angeles Cedars-Sinai Institute.

"The study showed that seven-year follow-up showed that patients who received a double-segment Prestige LP cervical disc replacement exhibited and maintained good clinical outcomes," Dr. Lanman said. "In the 84 months after surgery, patients who received a double-segment Prestige LP cervical disc replacement showed an overall clinical endpoint in patients who underwent anterior cervical discectomy and intervertebral fusion (ACDF). A greater overall success rate."

The randomized controlled device clinical study exemption (IDE) trial involved 397 subjects (209 study group patients who underwent double-segmental cervical disc replacement and 188 control patients who underwent conventional surgery) with a time span of up to seven year. Seven years later, the statistical analysis report concluded that patients who received a double-segment Prestige LP cervical disc replacement:
• Compared with patients who underwent double-segment cervical anterior discectomy for interbody fusion (ACDF) (success rate: 62.7%), had a greater overall success rate (success rate: 78.6%) (through Using Bayesian statistics, the probability of advantage = 99.8%). [1]
• Compared with patients who underwent double-segment cervical anterior discectomy for interbody fusion (ACDF) (success rate 82.1%), neurological improvement was higher (yield 91.6%) (introduction to advantage = 99.0%) )
• Compared with patients who underwent double-segment cervical anterior discectomy for interbody fusion (ACDF) (75.6% success rate), there was a greater success rate in clinical outcomes reported by patients, including cervical vertebrae Dysfunction index (87.0%) (probability probability = 99.3%).
• Compared with patients who received double-segment cervical anterior discectomy for interbody fusion (ACDF) (14.7%), the chance of secondary surgery was lower (4.2%).
• The incidence of postoperative adverse reactions was similar in both groups.

Risks of the Prestige LP cervical disc system include, but are not limited to, bone formation (including heterotopic ossification), which may result in spinal motor dysfunction or induced fusion in the surgical or adjacent segment.

“This is a long-term clinical study of double-segment cervical arthroplasty in the United States,” said Tommy Kars, vice president of spine R&D at Medtronic Recovery Therapy Group. “We are working to develop meaningful innovations. Products such as the Prestige LP cervical disc system are fundamentally changing the lives of patients. It is really exciting to see the Prestige LP cervical disc system that keeps patients well for seven years."

Reference materials:
[1] Overall Success is decided by combining the results from four different measurements of safety and effectiveness.

Source: Kexun Medical Network

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