FDA Clears Medtronic’s Ligament Augmentation System for Spine Surgery

The FDA recently approved a new type of device for the LigaPASS 2.0. The device is specifically designed to assist with spinal surgery that includes ligament augmentation. One of the primary reasons that the device was approved was because it has been successful in helping to reduce the post-operative complication of proximal junctional kyphosis (PJK) after adult spinal deformity surgery. When adults undergo surgery to correct spinal deformity, PJF or proximal junctional failure can be caused by mechanical failure following the surgery

The maker of this device conducted a study that included 242 cases where the device was used, and it found that patients who had the device experienced significantly lower risk of both complications. They were also far less likely to require reoperation rate, with only 3.3% requiring reoperation, compared to 15.6% among those who did not have ligament augmentation. The device is also able to be paired with the UNiD adaptive spine intelligent platform, which allows for the collection and analysis of the procedures to help surgeons plan for future surgeries.

If you would like to learn more about this new type of surgery and when it might be available, you can read the full article at FDA Clears Medtronic’s Ligament Augmentation System for Spine Surgery.

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