Issue link: https://beckershealthcare.uberflip.com/i/1507099
Spinal Stabiliza on Technologies, LTD are trademarks of Spinal Stabiliza on Technologies, Ltd, PerQdisc™ Nucleus Replacement System. The PerQdisc Nucleus Replacement System is currently not FDA-approved or for sale in the United States. The Spinal Stabiliza on Technologies PerQdisc is approved for sale in regions that accept the CE Mark. This adver sement is for general informa on and educa onal purposes only. It is not intended to provide medical diagnosis or medical services. Treatment is not for everyone. Please see the package insert for the complete list of indica ons, warnings, precau ons, and other important medical informa on. *LOPAIN1 and Nucleus 181 clinical trials data on file. Contact SST for more informa on. PerQdisc ™ Nucleus Replacement System Clinical Studies * have shown the PerQdisc: • Significantly reduces disability (Based on the Oswestry Disability Index Score) • Significantly reduces leg pain (if present) between 6 and 12 months a er surgery • Reduces the level of pain medica on between 6 and 12 months a er surgery • Is resistant to expulsion • Maintains Range of Mo on (RoM) • Preserves disc height Intended Use The SST PerQdisc Nucleus Replacement System is intended to replace the nucleus pulposus of the intervertebral disc in the L1-S1 spinal region. The PerQdisc is currently being evaluated in two Clinical Trials. The LOPAIN2 Trial is designed to gather addi onal long-term safety and efficacy data. Pa ent's must be 21 years or older with moderate to severe low back pain (a ributed to DDD) that have been unresponsive to conserva ve treatments. The LOPAIN3 Trial is an early feasibility study designed to collect safety and performance data on pa ents undergoing a discectomy, and concurrent PerQdisc Implanta on. Pa ents must be 21 years or older, presen ng with symptoma c radiculopathy from a focal lumbar disc hernia on that requires surgical decompression. Risks Associated with the PerQdisc Nucleus Replacement For a complete list of pa ent qualifica ons, general warnings and precau ons, and complica ons, visit sstspine.com/perqdisc • Anatomical or technical difficul es at me of implanta on • Allergic or foreign body reac on to the materials • Back pain due to altered spinal biomechanics • Technical problems with bending or breakage of surgical instruments or device delivery system • Development of new radiculopathy • Fracture, wear or breakdown of the PerQdisc device • Fusion of the spinal disc • Implant subsidence into the vertebral endplate(s) • Implant migra on outside of the vertebral space but not subsiding into the vertebral endplate(s) • Intra-opera ve findings that preclude implanta on of the PerQdisc device • Loss of neurological func on or interference with neural structures • Improper placement of the PerQdisc devices • No pain relief or worsening of pre-opera ve symptoms • Par al or complete expulsion of the PerQdisc from the spinal disc • Abnormal movement in the nuclear space SPINAL STABILIZATION TECHNOLOGIES ™ For more informa on about PerQdisc technology, visit: sstspine.com Flexion X-ray with PerQdisc in place. Extension X-ray with PerQdisc in place. The PerQdisc Nucleus Replacement System is currently not commercially available in any region.