We were responsible for both the design and development of the handheld device and controller unit, as well as manufacturing process development. We manufactured one of the critical components of the system in our cleanroom. As part of our involvement, we contributed to the drafting of submission documentation and supported DFine Inc. in the US regulatory approval process. Following the FDA’s approval and the market launch, DFine Inc. was acquired by Merit Medical.
StabiliT (DFine Inc.)
The StabiliT system is used in the treatment of vertebrae that are weakened and fractured as a consequence of osteoporosis. The StabiliT system stabilizes the injured vertebra through the injection of high-viscosity bone cement, with increased precision attributable to the system’s articulating distal end. Following the operation, patients can achieve improved quality of life.