SurGenTec Secures FDA Clearance and Unveils ION Screw, the Market's Smallest Posterior Spinal Fixation Implant

Friday, June 09, 2023

SurGenTec®, a privately held spine and orthopedic technology company based in Boca Raton, FL, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for ION™ Screw, its proprietary stand-alone spine fixation implant. This unique device can be used to treat a variety of pathologies throughout the spine from C2-S1. The patented ION implant is the smallest posterior fixation implant cleared for spine surgery – smaller than the size of a dime – and can be placed through a tiny incision with minimal tissue disruption. ION screws are enhanced with Nanotex™ surface technology designed with bony interdigitation in mind. ION provides patients with a treatment option between conservative care and major interbody fusion in the algorithm of care. "The ION screw technology revolutionizes spine surgery by offering an alternative to traditional metallic devices like pedicle screws and interspinous plates. Patients are seeking options that are less bulky and invasive, and the ION system provides excellent fixation with a zero-profile design. Travis Greenhalgh, the Founder and CEO of SurGenTec, expressed excitement about adding ION to their portfolio, highlighting years of pre-clinical research and development that went into creating this novel spinal fixation option. Greenhalgh added that the micro implant with unique surface technology provides fixation without the need for cumbersome implants.

The versatility of the ION system allows it to be used in various open or minimally invasive surgery applications, including facet fusions, adjunct to decompressive procedures, treating adjacent level disease, and providing added stability with interbody fusions. The ION facet screw system instruments were specifically designed to minimize tissue trauma, reduce incision size, and facilitate accurate placement of the ION implants. Andrew Shoup, the Chief Operating Officer of SurGenTec, emphasized that the ION system is well-suited for ambulatory surgery centers as it offers a cost-effective solution that minimizes trauma while delivering high-quality spinal care. He also mentioned that patients are increasingly seeking more efficient operating environments with reduced risk of illness and disease transmission.

Dr. Dawood Sayed, a Division Chief and Professor of Anesthesiology and Pain Medicine at The University of Kansas Medical Center, praised the ION facet screw system as a game-changer in the treatment of chronic degenerative lumbar conditions. He noted that traditionally, patients with these conditions are offered temporary relief through injections, ablations, or invasive open surgeries. The ION system fills an important gap by providing less invasive options for these debilitating conditions. Dr. Sayed expressed his honor in being among the first to offer this remarkable treatment at their medical center.

Unlike other spinal fixation options, the ION system has a zero-profile design, which minimizes soft tissue contact and potential irritation. The implants can be packed with bone graft material to facilitate fusion and prevent migration. Orthopedic spine surgeon Dr. Raphael Roybal from Coral Gables, FL, described the ION system as intuitive and safe, enabling him to provide less invasive solutions for advanced spinal conditions. He noted that the standard of care is evolving, and ION offers a simple solution to address complex spinal conditions.


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