SurGenTec Unveils ION Screw for Posterior Spinal Fixation

SurGenTec has earned U.S. Food and Drug Administration (FDA) clearance for its ION screw, a stand-alone spinal fixation implant for use in the C2-L1 levels. According to the company, at a size smaller than a dime it’s the smallest posterior fixation implant cleared for spine surgery.
 
The ION screw can be placed via a tiny incision with minimal tissue disruption. Proprietary Nanotex surface technology facilitates bony interdigitation, and the treatment option falls somewhere between conservative care and major interbody fusion.
 
“The ION screw technology truly changes the game for spine surgery,” Travis Greenhalgh, founder and CEO of SurGenTec told the press. “Patients are looking for options outside traditional bulky metallic devices such as pedicle screws and interspinous plates. This minimally invasive option provides excellent fixation with zero profile. It’s a non-intimidating solution for patients that need to undergo a spine surgery procedure. We are thrilled to announce the addition of ION to our portfolio. Our team has put years into pre-clinical research and development to create this truly novel spinal fixation option. Our team managed to create a ‘micro’ implant with a unique surface technology that provides fixation without the need for cumbersome implants.”
 
ION can be used in open or minimally invasive applications including facet fusions, adjunct to decompressive procedures, treatment of adjacent level disease, or to provide added stability with interbody fusions. ION’s instruments were designed to minimize tissue trauma and incision size.
 
“The ION system is a great fit for the ambulatory surgery center environment by providing a cost-effective solution for physicians looking to minimize trauma while still providing a high level of spinal care to patients. Patients are demanding access to a more efficient operating environment with less risk of illness and disease transmission,” said Andrew Shoup, COO of SurGenTec.
 
“ION represents a tremendous paradigm shift in the ability to treat my patients suffering from chronic degenerative lumbar conditions more definitively and less invasively,” said Dawood Sayed M.D., Division Chief and Professor of Anesthesiology and Pain Medicine at The University of Kansas Medical Center. “Traditionally, our patients with chronic back pain from lumbar degenerative disc disease, spondylosis, and spondylolisthesis are offered temporary relief with injections and ablations or invasive open surgical procedures. ION bridges an important gap for patients and physicians seeking less invasive options for these debilitating conditions. I am very honored to be amongst the first in the world to offer this remarkable treatment at our medical center.”
 
ION has zero profile above the bone. The implants can be packed with bone graft before and after insertion to facilitate fusion, allow the bone to bridge over the implant, and prevent migration.