8 Lumbar Artificial Discs to Know..!

According to Global Market Insights, the Artificial Disc Market size surpassed USD 1.6 billion in 2019 and is projected to achieve over 18.6% CAGR up to 2026. Growing awareness among people regarding benefits of disc replacement procedure over spinal fusion surgeries will further upsurge the industry growth.

Increasing prevalence of orthopaedic diseases in developed as well as developing economies is the key factor that will drive artificial disc market revenue during the forecast period. Degenerative disc diseases (DDD) are often attributed to upright and bipedal locomotion that exerts mechanical stress on the vertebral column. DDD is directly co-related with age. High adoption of sedentary lifestyle coupled with increasing number of baby boomers worldwide prone to various musculoskeletal diseases will thus accelerate the market growth.

Lumbar artificial disc market segment is estimated to witness around 18% CAGR over the forecast period due to rapidly growing geriatric patient pool suffering from orthopaedic diseases. Low back pain (LBP) is one of the major disabilities among the geriatric population that limits functionality and decreases the quality of life. Increasing prevalence of LBP will increase the demand for lumbar total disc replacement (LTDR) procedures, thereby boosting the lumbar artificial disc segment growth. Growing applications of LTDR procedure in patients with discogenic pain and degenerated lumbar spine will further spur the market size.

U.S. artificial disc demand accounted for around USD 800 million in 2019. Market size is attributed to rising prevalence of DDD and surge in number of people undergoing disc replacement procedures in the country. Strong foothold of key industry players in the U.S. will subsequently increase the demand for new and advanced devices among people, thereby driving the regional market growth during the forthcoming years. Moreover, partial government support for disc replacement procedures due to its advantages over the traditional methods will further augment the regional artificial disc industry growth.

Competition:

In the past, there have been many key players operating in the Lumbar artificial disc (Please visit our Artificial Lumbar Section) but today there number of competitors is limited. The 8 most relevant Lumbar Artificial disc are the following:

1.-prodisc L Total Disc Replacement | Centinel Spine

The prodisc L implant has been designed to maintain the physiological range of motion in the spine. The implant was developed using the clinically proven ball and socket concept used in joint replacement implants for over 40 years.

FDA Approved: YES

Endplate Material

The prodisc L implant is composed of three components – two cobalt chrome alloy (CoCrMo) endplates and an ultra-high molecular weight polyethylene (UHMWPE) inlay.

Features:

• 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.
• Secure Fixation
  • Patented central keel and lateral spikes provide secure primary fixation
  • Plasma-sprayed titanium surface on bone contacting surfaces promotes integration
• Anatomical Sizing
  • 12 anatomical combinations facilitate an accurate match with the patient’s anatomy
    • Medium and large footprints
    • 10, 12 and 14 mm heights
    • 6° and 11º lordotic angles
• Safe and Reproducible Surgical Technique
  • Working with leading spine surgeons from around the world, the prodisc L instrumentation and surgical technique has been refined to facilitate safe and reproducible implantation through a midline, mini-open anterior approach to the lumbar spine.
• Streamlined Instrumentation
  • Designed for midline, mini-open anterior approach
  • Enables clear visualization into the disc space
  • Minimizes exposure and risk of damage to vascular structures

2.- activL Artificial Disc | BBRAUN

activL® is the lumbar disc prosthesis for the motion preserving treatment of degenerative disc disease of the lumbar spine. The main objectives of the treatment are fast pain reduction and the preservation/restoration of segmental function and motion. The specific design of activL® allows the protection of the adjacent level. The uniplanar translational movement of activL® is designed to minimize biomechanical stress at the facet joints and to avoid facet joint arthrosis in a medium- and long-term prospect.

FDA Approved: YES

Endplate Material

The activL Artificial Disc consists of two endplates made of cobalt-chromium metal alloy with a titanium coating and a plastic insert that fits between the two endplates. The plastic insert is flat on the bottom and round on the top and is designed to move as you move during daily activities. 

Advantages

• Unique translational movement to avoid biomechanical stress at the facet joint
• Unique translational movement for an effective protection of the adjacent disc levels
• Anterior and antero-lateral approach possible
• Specific instrumentation for the antero-lateral approach
• Design of prosthesis plates adapted to the anatomy of vertebral body endplates
• Specific prosthesis design treatment of L5-S1
• Plasmapore® coating for a fast and safe bony integration of the prosthesis plates to the vertebral body endplates
• Spikes and/or Keels as primary stability structures. Can be used together in any combination.

Features

• Unique translational movement
• Convex prosthesis plates
• Anatomical adapted footprint
• Differentiated implant design for L5-S1
• Spikes and/or Keel
• Plamapore® coating
• Specific PE material for the Inlay
• Smallest height with 8.5 mm
• Instrumentation for the lateral approach
• Free choice of direction of approach (angulation)
• Revision instruments

3.-Mobidisc^® L Lumbar Disc Prosthesis | Zimmer Biomet

The innovative VerteBRIDGE^® anchoring technology combined with a mobile core offering controlled mobility provides a unique solution that fulfils two requirements of lumbar arthroplasty: restoring the physiological mobility of the treated segment and optimal positioning of the implant.

Features:

• Core with controlled mobility
  • The mobile core of Mobidisc^® L combines rotation with translation to respect the Instantaneous Centers of Rotation (ICR) and to preserve the action of the articular facets.
  • The self-positioning of the core helps restore the physiological mobility of the segment while reducing intra and peri-prosthetic stresses.
  • 4 peripheral stops control the mobility of the polyethylene core within physiological limits and secure the implant.

• Easier insertion and positioning
  • The prosthesis can be implanted through a midline or paramedian approach depending on the level treated and the anatomy of the patient for a minimal mobilisation of the vessels.
  • The modular prosthesis holder allows an unrestricted and precise positioning of the prosthesis in the intersomatic space.
  • The millimetric adjustment of the adjustable stop guarantees an optimal positioning before placing the anchoring system.
  • The bevelled prosthetic endplates facilitate insertion while respecting the vertebral endplates.
  • Anchoring clips are only inserted after confirming the optimal positioning of the prosthesis.

• VerteBRIDGE^® anchoring
  • The self-guided insertion of the anchoring system in the axis of the disc and through the prosthesis holder is secure and minimally invasive.
  • Curved and self-locking anchoring clips hold the prosthesis securely in the intersomatic space. The pre-loading on single-use PEEK Classix^® loaders avoids any direct handling.
  • Zero-profile anchoring reduces the risk of the implant protuding outside of the intervertebral space.

• Adapted to patient anatomy
  • The wide range of dimensions (footprint, height, and lordosis) and anchoring clips lengths of the prosthesis means the implant is suitable for patients anatomies and makes procedures with hybrid assemblies much easier.

4.- Freedom® Lumbar Disc (FLD) | Axiomed

The FCD is intended to replace degenerated lumbar or cervical discs. The FCD polymer core is designed to provide the kind of stiffness similar to that found in healthy human discs. Like human discs, the core is viscoelastic, which means they respond to different loads and loading rates the way a human spine does.

FDA Approved: NO

Endplate Materials

The Freedom Disc is a one-piece viscoelastic total disc replacement (TDR) consisting of an elastomeric core bonded to titanium retaining plates. Its core material is CarboSil™ TSPU, a silicone polycarbonate urethane thermoplastic elastomer.

Benefits:

• Responds to loading like the human spine
• Withstands the forces and wear of decades of use
• Moves in three dimensions like the human spine
• Polymer core has flexibility and stiffness that mimics a healthy human disc

5.- Kineflex | Southern Medical

The Kineflex Prosthetic Disc (KPD) is constructed of two implant-grade cobalt-chromium molybdenum (CCM) endplates with titanium plasma-sprayed surfaces for osseointegration, and a CCM core. The core is in the shape of a bi-convex disc. Only one size core is utilized with all the system combinations. The endplates are provided in various heights, defined by their thickness relative to the disc centreline, with combinations ranging from 10mm to 13.75mm. The endplates are also provided with lordotic angles to result in wedge combinations of 5°, 10° and 15°. The Kineflex geometry replicates the natural motion of the intervertebral disc by allowing for five degrees of freedom. The CCM-on-CCM wear-couple produces low volumetric wear.

FDA Approved: NO

Endplate Materials

Cobalt-chromium molybdenum (CCM) endplates with titanium plasma-sprayed surfaces for osseointegration, and a CCM core.

Features

• Low profile anatomically shaped disc provides a close match to patient anatomy
• Unique three-part disc design allows for five degrees of freedom
• Intuitive instrumentation combined with a simple surgical procedure reduces theatre time

6.- LP-ESP | FH Orthopedics

The LP-ESP cervical disc prosthesis has been developped to mimic the natural lumbar disc and allow the spine to behave as if the replaced disc would be natural in all situations.

FDA Approved: NO

Endplate Material

The LP-ESP is made of titanium endplates and a hydroxyapatite coating.

Features

• Over 10 years of research and development
• 10 years of follow up (since 2004)
• 6° of freedom
• Adaptive center of rotation
• No surface bearing for an increased lifetime
• Improved stability
• shock absorbing
• Designed to fit and restore patient lordosis

7.-ORBIT™-R | Globus Medical

ORBIT™-R is the first total disc replacement combining physiologic motion with imaging compatibility. The selectively constrained dual articulating design of ORBIT™-R allows the facets to guide motion without compromising stability. ORBIT™-R is made from polyethertherketone (PEEK) allowing superior imaging compatibility for improved clinical evaluation. Streamlined instrumentation accommodates efficient implant delivery and uncompromised repeatability.

FDA Approved: NO

Endplate Materials: Polyethertherketone (PEEK)

Benefits

• Radiolucent: ORBIT™-R is made from a radiolucent polymer (PEEK) for imaging compatibility
• Quality of Motion: ORBIT™-R’s selectively constrained dual articulating design adjusts to the natural center of rotation while permitting physiologic quality motion without compromising stability
• Streamlined Procedure: Instrumentation allows for seamless, repeatable placement and enables as a single assembly

8.- BAGUERA® L | Spineart

Not FDA Approved

Endplates Materials:

The BAGUERA inferior and superior end-plates are made of Titanium Alloy (Ti-6Al-4V ELI), Grade 23 (6% Aluminum, 4% Vanadium, 0.13% (maximum) Oxygen).The Thin layer over superior and inferior end-plates is made of Diamolith.The nucleus is Polyethylene. “Polyethylene is a light, versatile synthetic resin made from the polymerization of ethylene,” and “is of low strength, hardness and rigidity, but has a high ductility and impact strength as well as low friction. It shows strong creep under persistent force.”

Features

• Reduced MRI Artifact :The titanium plates reduce artifacts under the MRI and improve the postoperative control. The plates are coated with DIAMOLITH®.
• Shock Absorption  :The shape of the inferior plate and the PE nucleus are designed to enable absorption of shocks and vibrations.
• Mobile of Fixed Nucleus :The BAGUERA®L concept allows the surgeon to choose the mobility of the nucleus intraoperatively, without changing the superior or inferior plates. The movement of the mobile nucleus is controlled to respect rotation movements.
• Primary Stability :The porous titanium coating as well as the 5 upper and 5 lower fins are designed for primary and secondary stability.