imds: Innovative Medical Device Solutions
Pioneering a market in record time
Percutaneous Pedicle Screw and Rod System
Challenge
The Chief of Orthopedic Spine Surgery at a prominent university medical center had an innovative concept and a pending patent application for a true percutaneous pedicle screw and rod system. The surgeon sought out IMDS for our Co-Innovation™ services because of our reputation for unparalleled speed-to-market, innovative design and prototyping abilities, and the value that we could contribute to the partnership. The surgeon and IMDS saw the clinical benefits and possibilities of the concept, and quickly developed a partnership and vision of what this system could become.
Traditional treatments for the indicated pathology included spinal fusion using pedicle screws and rods inserted via a mini-Wiltse approach. This approach is less invasive than traditional midline or open approaches, but still results in significant access-related trauma and post-op pain. Percutaneous systems began to surface in an attempt to address these issues. However, there were significant shortcomings of these newer systems that could be overcome if we could find the right combination of innovative design, techniques, features and instrumentation.
Solution
The solution was an innovative system that docks soft tissue retractor blades directly to the implant, which allows for a true percutaneous posterior fusion without additional stab wounds and that affords a high level of visualization and control to the surgeon. The implant design incorporated a novel modification to current pedicle screws which allows the pedicle screw to have a releasable connection to radiolucent retractor blades which keep the small incisions open and maintains direct visualization of the screw head. Novel and extremely easy-to-use instrumentation was developed to cooperate with the retractor blades to provide easy insertion, guidance down to the pathology, and above-the-skin rod contouring options for the surgeon.
Results
The system was designed, prototyped, and feasibility was demonstrated in record time. The technology was coveted by a number of orthopedic medical device manufacturers, and a partnership was quickly developed with one of the leading orthopedic companies to bring the system to market. The system is now commercially available and is affording surgeons a new standard in minimally invasive surgical options for spinal treatment. The system has been used with great success in procedures around the world from 1-level to multi-level posterior fusions.
