1. The study evaluated patients who had surgery with the device for symptomatic degenerative disc disease and spinal stenosis.
2. Analyses of the patients at six-months found sustained improvement in clinical efficacy and safety compared to three-month evaluations.
3. Reserachers concluded, “This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the interspinous fusion device. Our analysis showed a sustained improvement in clinical efficacy, and safety endpoints, when compared to the 3-months evaluations, across both interventional pain and neurosurgery specialties.”
4. The Zip system was cleared by the FDA inn 2013 and went to market in 2014.
