What the Data Shows (So Far)

While long-term data is still limited, early results are encouraging:

• A European prospective study on lumbar VTDR patients (L4-5 or L5-S1) reported:

• ODI improvement from 48% to 23%

• Back pain VAS reduction from 7.1 to 2.9

• No device-related failures at 2-year follow-up
  (Source: International Journal of Spine Surgery)

• Mechanical testing has shown durability through 50 million cycles (approx. 50 years of use), maintaining stiffness and height.
  (Source: AxioMed lab data)

• U.S. FDA trials are ongoing, with final regulatory modules submitted. Approval could follow pending facility inspections and trial results.

Key Points of Discussion

Potential Benefits

• Closer replication of natural disc mechanics

• Less facet overload vs. traditional TDRs

• Lower wear debris potential due to absence of hard articulating surfaces

Ongoing Concerns

• Lack of long-term U.S. clinical data

• Limited revision pathways and removal challenges

• Uncertain outcomes in multi-level or complex pathology cases

Where It Stands

Viscoelastic disc replacement may represent an evolution in disc arthroplasty—offering a design that addresses some of the biomechanical criticisms of earlier TDRs. But broader adoption will likely depend on upcoming FDA results, long-term outcomes, and surgeon experience across diverse patient populations.

For now, it remains a technology to watch—with the potential to expand the conversation on motion preservation in spine care.