Learn All About this Clinically-Proven Alternative to Spinal Fusion

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ABOUT prodisc

prodisc is a Total Disc Replacement (TDR) technology platform that offers a surgical treatment proven to maintain spinal balance and motion, decelerate adjacent level reoperations, and accelerate the return to normal activities.

It is the only total disc replacement system in the U.S. approved for two-level use in the lumbar spine

Centinel Spine is currently the only company in the United States to offer Total Disc Replacement devices for both the cervical and lumbar spine:

  • prodisc L:
    Total Disc Replacement for the lower (lumbar) spine (L3-S1)

  • prodisc C & prodisc C Vivo*:
    Total Disc Replacement for the upper (cervical) spine (C3-C7)

*Not available in the U.S. at this time

Not all products are available in all markets.

prodisc USAGE

The 1st implantation of a prodisc L took place in 1990, and the 2nd generation design received US PMA approval in 2006.

With such a lengthy clinical history and global usage, the prodisc line of total disc replacements are the most widely studied TDRs in the world.

30+
30+ Year Clinical History with Worldwide Usage


prodisc design has been validated with almost 225,000 device implantations worldwide 1 and more than 540 published papers 2

2L
The only total disc replacement system in the U.S. approved for two-level use in the lumbar spine


Almost 225,000 device implantations and a reported reoperation rate of less than 1%

prodisc STUDIES

No other disc replacement system has been studied more than prodisc.

With more than 540 published papers, reporting on experiences with over 13,000 patients, the clinical data for prodisc strongly supports its safety and effectiveness. Here are just a few key takeaways from these numerous clinical studies:

4x
Fewer Reoperations

After 7 Years with prodisc C vs. Patients that Received a Fusion (ACDF)3

4x
Less Likely Adjacent Level Degeneration

After 5 Years with prodisc L vs. Patients that Received a Fusion (ALIF)4

LOWER
Change in Range of Motion

Shown in Biomechanical Study of prodisc C vs. a Plate-Based Fusion (ACDF)5

prodisc DESIGN

The prodisc design is based on two critical principles: a mechanism of action & post-operative fixation.

Mechanism of Action

The prodisc implant is a ball and socket design with a fixed center of rotation. This patented design has been in clinical use since 1990 and utilized across the entire product platform. The fixed center of rotation allows physiological range of motion while providing stability to the spine and significantly reducing reoperations at the adjacent levels.


Fixation

Immediate Post-Operative Fixation
Immediate post-operative fixation is provided by the midline keels, ensuring the implant is securely held in place so the patient can begin rehabilitation and return to their normal activities as soon as possible.

Long-Term Fixation
The entire surface of the implant that is in contact with the vertebra is coated with a highly porous plasma sprayed titanium coating. This allows for bony on-growth into the porous surface of the implant for long term, secure fixation.


prodisc OBJECTIVES

prodisc was developed with several specific patient care objectives in mind:

Maintaining Spinal Motion

Degenerative disc disease can destabilize your spine. In order to protect adjacent segments of the spine from diseased segments, prodisc is designed with a fixed center of motion, enabling translation only with bending motion.

Controlled & Predictable Motion
Unlike other designs, prodisc is designed to enable physiologic motion in the degenerated spine.

Range of Motion
prodisc allows a normal range of motion while providing stability through controlled translation.

Reducing Adjacent Level Disease

The ‘gold standard’ for treating degenerative disc disease is to conduct a fusion and fuse the joint. However, immobilizing a segment of the spine has been shown to increase the rate of adjacent level degeneration. prodisc has been shown in multiple long-term studies to decrease the development of adjacent level disease.3

Range of Motion
Long-term prospective randomized multi-center evidence illustrated patients retained range of motion of 8.12° at 7 years.3

Resuming Activities of Daily Living

Degenerative disc disease can be very painful, and recovery from spinal surgery can take time. Special care has been taken to design prodisc to minimize the recovery associated with the procedure. In a study comparing prodisc and fusion, surgeons found that patients that received the fusion treatment option lost nearly twice as much blood during the procedure, spent nearly twice as much time in the OR, and had longer hospital stays.

Patented Midline Keel

  • The prodisc keel is specifically designed to provide immediate stability, making post-op bracing optional.
  • A study on military personnel (over 50% of the participants were Navy SEALs) found that 83% returned to active duty after receiving a prodisc L versus 67% that had received an ALIF.6

See the prodisc C Surgical Technique Animation

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See the prodisc L Surgical Technique Animation

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prodisc TECHNIQUE

Learn more about the elegant prodisc procedure.

MORE ABOUT prodisc

For more information about prodisc see our corporate website.

  TO THE CORPORATE WEBSITE

1 Data on file at Centinel Spine compiled from Spine Solutions, Synthes Spine, DePuy Synthes, and Centinel Spine.
2 Search performed on Pubmed, Embase, Ovid Medline® covering 1988 – 2018.
3 Janssen ME, et al, ProDisc-C Total Disc Replacement Versus ACDF for Single-Level Symptomatic Cervical Disc Disease, JBJS, 2015, 97:1738-47.
4 Zigler, J, Delamarter R, Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the prodisc L total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc disease, J Neurosurg Spine, 2012, 17:493-501.
5 Crawford NR, et al, Biomechanics of a Fixed-Center of Rotation Cervical Intervertebral Disc Prosthesis, Int J Spine Surg. 2012; 6: 34–42.
6 Tumialan, L.M., et al., Arthroplasty in the military: a preliminary experience with prodisc C and prodisc L. Neurosurgical focus, 2010. 28(5): p. E18.

EDUCATIONAL development

Centinel Spine offers a variety of educational programs tailored to meet the diverse training needs of physicians. Hands-on Bioskills Courses, Peer-to-Peer Webinars, and OR Surgical Observations have been designed to review patient selection, surgical technique and tips, post-operative care, and other related topics. These programs can be customized to individual physician needs, providing varied levels of support to surgeons.



About our
Hands-on Bioskills Courses

These courses provide surgeons with an educational experience focused on patient selection, surgical technique, strategies, and solutions for addressing specific spinal pathologies. The course format includes lectures, case discussions with expert faculty, and a bioskills lab.

The curriculum covers biomechanical considerations, indications and patient selection, surgical technique, tips and tricks, post-operative care, and best practices.



About our
Peer-to-Peer Webinars

Centinel Spine’s live streaming webinars provide a convenient way for physicians to learn from experts in anterior spinal motion motion preservation and fusion technologies discussing specific treatments, techniques, and strategies for patient care.

Our interactive webinars allow participants to pose questions, receive answers, and exchange ideas in real-time with their surgeon peers from the comfort of their homes or offices.



About our
Surgical Observations

Surgical Observations are a surgical technique training and continuing education program that exposes surgeons to the technical procedures and skills required for anterior column surgery, through a combination of case discussions and viewing live surgery.

Surgeon OR Visitations are offered at Centinel Spine experienced faculty locations, where key thought leaders in spine educate with a focus on the anterior spinal column.

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The Story of Centinel Spine

Watch this three minute primer on Centinel Spine and its unique and extraordinary place as a catalyst of change in the spine industry—with pioneering technologies and a clinical history that have led to successes ranging from PGA champions to a growing list of surgeon-patients.

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