imds: Innovative Medical Device Solutions
Pioneering new treatment options for improved quality of life
Facet Joint Replacement System
Challenge
The IMDS Co-Innovation™ team identified an unmet clinical need and innovated and patented a design for an anatomically based facet joint implant and instrumentation system. The associated intellectual property was acquired by an early stage, venture capital backed company dedicated to bringing the device to commercialization. Continuing R&D partnership between the company and IMDS Co-Innovation has resulted in the full development and clinical introduction of this novel implant and surgical instrumentation system.
Traditional treatment for the indicated pathology was rigid spinal fusion, which prevents motion and leads to future degeneration at adjacent spinal levels. The challenge was to design and develop a unique joint replacement device for the facet joints of the lumbar spine that replicated natural anatomy and biomechanics—something that had never been done before. The intended outcome was to address the painful pathology while maintaining motion and preventing the undesirable side effects of fusion. The technology was not currently available and represented a completely new and unproven treatment option. Furthermore, as part of the development strategy, additional challenges included navigation of FDA and European requirements to prove device safety for human implantation and move toward commercialization.
Solution
The solution was a novel cobalt-chrome and titanium implant system that replaces the right and left facet joints, maintaining motion and restoring the natural biomechanics of the spine while allowing the surgeon to address and relieve the painful and debilitating pathology. Accompanying the implant family was a complementary set of instruments, many of which are now patented or patent pending due to their novel form and function.
Results
The result of the development project is a unique, clinically viable, easy-to-use, well-functioning implant system that is currently underway in the FDA clinical trial process. Now, for the first time, properly indicated patients can potentially obtain pain relief without sacrificing normal motion of their lumbar spine.
Product
Facet Joint Replacement System
Services Utilized
