See coding and reimbursement information for the Prestige LP™ cervical disc.
Artificial cervical disc systems
Prestige LP™ cervical disc
Artificial cervical disc systems
Prestige LP™ cervical disc
The Prestige LP™ cervical disc is an articulating artificial cervical disc for use in one- or two-level disc replacement procedures.
Description
Cervical arthroplasty with the Prestige LP™ disc
The Prestige LP™ cervical disc is a two-piece articulating metal-on-metal device designed to allow motion after implantation. It is also the first FDA approved one- and two-level cervical disc with 10-year investigational device exemptions (IDE) study data.
Features
Meet the Prestige LP™ cervical disc.
Discover features and benefits of the Prestige LP™ cervical disc:
- Proprietary titanium ceramic composite material contains no nickel, cobalt, or chromium
- Titanium ceramic composite for a lower steady state wear-rate of combined motion than stainless steel in combined motion testing1
- 10-year clinical study data for one-and two-level IDE trials2
- Consolidated instrument configuration for improved cost and efficiency†
Unique Ti ceramic composite
Preserves motion
Enhances and secures fixation‡
Implant material demonstrating lower state of wear
- Titanium ceramic composite material (TiC) contains zero nickel, cobalt, or chromium
- TiC metal ion study,3 performed as part of U.S. Investigational Device Exemption (IDE) clinical trials
- TiC demonstrated satisfactory MRI clarity versus cobalt-chromium or stainless steel discs§,4
Risks include wear debris.
The titanium carbide is not a coating on the implant. It is a component of the material mixture.
Specially-designed material allows satisfactory post-operative assessment
A computed tomography (CT) myelogram may be required for adequate visualization; MR conditional at 1.5 and 3 Tesla
Motion preserving implant
Range of motion with the Prestige LP™ cervical disc system
- Ball and trough articulation is designed to allow for a variable center of rotation (COR) that is located within an intended physiological area of the cervical spine
- Allows for a maximum of 10 degrees of lateral bending and flexion/extension from neutral, unlimited axial rotation and ± 2 mm AP translation
- Has no mobile core that could migrate from the device postoperatively
Risks include loss of motion.
Streamlined instruments
Surgical technique and fixation with the Prestige LP™ streamlined instrument set
- Predictable, reproducible implant positioning with cannulated drill and rail punch designed to allow trial to remain in disc space between steps to prevent collapse or loss of midline◊
- Low profile press-fit rails with anti-migration teeth for fixation
- Commercially pure titanium (CP Ti) plasma thermal sprayed coating designed to permit bony on-growth for additional device incorporation.
Prestige LP™ surgical technique animation
See how Prestige LP™ works.
Ten-year clinical outcomes
A prospective, randomized, controlled, multicenter FDA-approved clinical trial assessed the ten-year clinical safety and effectiveness of cervical arthroplasty compared to anterior cervical discectomy and fusion (ACDF).2 The clinical trial involved 397 patients (209 patients who received the Prestige LP™ cervical disc at two adjacent levels and 188 patients who underwent a fusion procedure, ACDF, at two adjacent levels).
Summary of key results
- 2 times fewer serious adverse events2
- 3 times fewer index level reoperations2
- 2 times fewer adjacent level reoperations2
Through two years after surgery, 5 out of 209 patients (4.7%) treated with the Prestige LP™ cervical disc at two adjacent levels and 15 out of 188 patients (17.6%) treated with ACDF at two adjacent levels had additional surgery at the same levels. In addition, 5 out of 209 patients (9.0%) treated with the Prestige LP™ cervical disc at two adjacent levels and 6 out of 188 patients (17.9%) treated with ACDF at two adjacent levels had additional surgery at a level adjacent to the levels originally treated.
Ten years after surgery
Through ten years after surgery, 9 out of 209 patients (4.3%) treated with the Prestige LP™ cervical disc at two adjacent levels and 27 out of 188 patients (14.4%) treated with ACDF at two adjacent levels had additional surgery at the same levels. In addition, 16 out of 209 patients (7.7%) treated with the Prestige LP™ cervical disc at two adjacent levels and 24 out of 188 patients (12.8%) treated with ACDF at two adjacent levels had additional surgery at a level adjacent to the levels originally treated.
This product may be protected by U.S. patents listed at medtronic.com/patents.
† As compared to original Prestige LP™ instruments (2014).
‡ Not necessarily indicative of clinical results.
§ CT myelogram may be required for adequate visualization; MR Conditional at 1.5 or 4 Tesla.
◊ Pin distraction optional.
- Based on mechanical testing according to ISO (18192-1) and ASTM (F2423-05).
- Gornet MF, Lanman TH, Burkus JK, et al. Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial. J Neurosurg Spine. 2019;31(4):508–518. doi:10.3171/2019.4.SPINE19157.
- Gornet MF, Singh V, Schranck FW, Skipor AK, Jacobs JJ. Serum metal concentrations in patients with titanium ceramic composite cervical disc replacements. Spine (Phila Pa 1976). 2017;42(6):366–371. doi:10.1097/BRS.0000000000001745.
- Sekhon LH, Duggal N, Lynch JJ, et al. Magnetic resonance imaging clarity of the Bryan, Prodisc-C, Prestige LP™, and PCM cervical arthroplasty devices. Spine (Phila Pa 1976). 2007;32(6):673–680.