SurGenTec receives FDA clearance for ION screw spine fixation implant

1490

SurGenTec has received clearance from the US Food and Drug Administration (FDA) for ION screw, its proprietary standalone spine fixation implant which can be used to treat a variety of pathologies throughout the spine from C2-S1.

According to SurGenTec, 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 company adds.

Travis Greenhalgh, founder and chief executive officer of SurGenTec, said: “The ION screw technology truly changes the game for spine surgery. 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 a variety of open or true minimally invasive surgery (MIS) applications including facet fusions, adjunct to decompressive procedures, the treatment of adjacent level disease or to provide added stability with interbody fusions. The ION facet screw system instruments were designed to minimise tissue trauma and incision size while delivering the ION implants to the surgical location, say SurGenTec.

The company’s chief operating officer, Andrew Shoup, said: “The ION system is a great fit for the ambulatory surgery centre environment by providing a cost-effective solution for physicians looking to minimise 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.”

Dawood Sayed of the University of Kansas Medical Center (Kansas City, USA) commented: “ION represents a tremendous paradigm shift in the ability to treat my patients suffering from chronic degenerative lumbar conditions more definitively and less invasively.

“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 honoured to be amongst the first in the world to offer this remarkable treatment at our medical centre.”

Raphael Roybal, an orthopaedic spine surgeon (Coral Gables, USA) added: “Using the ION system was intuitive and safe. It allowed me to provide a less invasive solution than I would have typically provided. The standard of care is changing, and ION offers a simple solution to advanced spinal conditions.”


LEAVE A REPLY

Please enter your comment!
Please enter your name here