Prestige LP

Question 1

Trialing / Implant Size Tips

Answer 1

Trial should fit snug without distracting the disc space. If more than gentle tapping is required to insert the trial into disc space consider a smaller implant. Make sure anterior tabs on trial are snug against anterior vertebral body. Trial should reach the Posterior aspect of the body. Better to go longer than using taller Implant.

Question 2

Steps for Prestige LP implantation

Answer 2

1. Perform discectomy and prepare endplates.
2. Insert appropriate size trial.
3. Slide drill guide over trial and drill pilot holes
4. Remove drill guide and insert rail punch
5. Attach Implant to inserted and Implant in patient.

Question 3

How many turns do you need to perform to correctly capture Implant on inserter?

Answer 3

12

Question 4

Height / Length Implant options available?

Answer 4

Height Length
5mm - 12, 14, and 16
6mm - 12, 14, 16 and 18
7mm - 14, 16 and 18

Question 5

What is the length and diameter of rail cutter bit

Answer 5

9mm Length
1.5mm Diameter

Drills 9.3mm deep in bone

Question 6

When implanting, what is the proper orientation for the Prestige Implant.

Answer 6

Ball side is superior or on top.

Question 7

What are the contraindications for Prestige LP

Answer 7

The PRESTIGE LP™ Cervical Disc should not be implanted in patients with
the following conditions:
• Active systemic infection or localized infection at the surgical site;
• Osteoporosis or osteopenia defined as a DEXA bone mineral density
T-score ≤ -1.0;
• Allergy or sensitivity to titanium, aluminum or vanadium;
• Marked cervical instability on neutral resting lateral or flexion/extension
radiographs; translation >3.5mm and/or >11° rotational difference from
that of either level adjacent to the treated levels;
• Severe spondylosis at the level to be treated, characterized by bridging
osteophytes, loss of disc height >50%, an absence of motion (<2°) as
this may lead to a limited range of motion and may encourage bone
formation (e.g. heterotopic ossification, fusion);
• Severe facet joint arthropathy;
• Significant cervical anatomical deformity or clinically compromised
vertebral bodies at the affected level(s) due to current or past trauma
(e.g., by radiographic appearance of fracture callus, malunion or
nonunion) or disease (e.g., ankylosing spondylitis, rheumatoid arthritis);
or
• Significant kyphotic deformity or significant reversal of lordosis.

Question 8

What is composition of Prestige LP Implant and why is it significantly unique.

Answer 8

Titanium ceramic composite. 
Titanium Alloy (Ti-6Al46-4v) and Titanium Carbide are mixed to form the materials stock. 

Reduction in post-op MRI artifact

Implant comprised of two pieces machined from solid titanium carbide.
Unlike other artificial discs, Prestige doesn’t use a mobile or free floating core eliminating potential of Implant core expulsion.

Question 9

What is the range of motion offered by Prestige LP.

Answer 9

Designed to allow a minimum of 10° Flexion/Extension from neutral and +- 2mm A/P translation in Sagittarius plane.

Designed to allow a minimum of 10° lateral bending from neutral.

Designed to allow for unlimited axial rotation (constrained by ligaments and posterior elements).

Question 10

Where is the center of rotation in the cervical spine and how does Prestige LP preserve physiologic motion?

Answer 10

The centers of rotation for each spinal unit in the cervical spine are located in the posterior portion of the motion segment.

The Prestige LP Implant has a ball-and-trough design located in the posterior portion of the device.

Question 11

Does Prestige LP contain Chromium, Cobalt and Nickel

Answer 11

No, only Titanium, Vandium, Aluminum and Titanium Carbide.

Question 12

What wear study was performed and what did it demonstrate?

Answer 12

The preclinical study evaluated local and distant tissue reaction to it Carbide, and potential toxicity to Carbide wear debris.

Question 13

Why use a ball and trough design?

Answer 13

The design allows coupled SEMI-CONSTRAINED motion including Flexion, Extension, Lateral bending and Axial rotation. This design also helps ELIMINATE facet distraction during flexion.

Question 14

When was Prestige released? When did it get 2 level clearance

Answer 14

Received 1 level FDA approval in 2014

Received 2 level FDA approval in 2016

Question 15

Prestige LP indications and product goals

Answer 15

The Prestige LP™ Cervical Disc System is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single and two-level adjacent discectomy for intractable radiculopathy and/or myelopathy; and is designed to
restore and maintain disc height, maintain motion in the cervical spine, and serve as an alternative to cervical fusion.

Question 16

Who are ideal Prestige LP patient candidates?

Answer 16

Patients receiving the Prestige LP™ Cervical Disc System should meet the FDA labeling criteria: no more than two adjacent diseased levels, no more than 50% disc space height collapse, have good bone quality, and have failed at least six weeks of non-operative treatment. Please see package insert for complete list of indications, warnings, precautions, and other medical information.

Question 17

What FDA Classification Device is Prestige. 1,2 or 3

Answer 17

Prestige LP is a class 3 device because these pose the highest risk due to design complexity and use. Class 3 devices must follow a rigorous regulatory process for approval (i.e. clinical trial). Other MDT Class 3 products - Infuse, Bryan, and Prestige LP/SS.

Question 18

How does Prestige LP compare to ACDF, how was this conclusion determined?

Answer 18

Compared to ACDF, the Prestige LP disc was shown to be statistically superior in overall success (without FSU) at 24 months (posterior probability of superiority = 99.5%). It was shown to be statistically non-inferior in overall success (with FSU) at 24-months (posterior probability of non-inferiority = 99.5%)

This is a claim (conclusion) based upon the findings at 24months from the single-level clinical trial using Prestige LP.