Enhanced Pedicle Screw System Harnesses Nanotechnology

An innovative pedicle screw system with a bioceramic nanotube surface encourages osteoblast and mesenchymal stem cells (MSC) adhesion.

The Nanovis (Carmel, IN, USA) Nano FortiFix is a thoraco-lumbo-sacral screw system designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the non-cervical spine. Indications include back pain of discogenic origin with degeneration of the disc (DDD), as confirmed by history and radiographic studies; spinal stenosis, spondylolisthesis, and trauma; and spinal deformities such as scoliosis, kyphosis, and/ or lordosis), tumors, pseudarthrosis, and failed previous fusion.

The system consists of chrome cobalt rods and titanium alloy polyaxial pedicle screws, connectors, and fasteners in a variety of sizes to accommodate differing anatomic requirements. The Nano FortiFix pedicle screw shaft itself is available with or without a micro- and nano-roughened surface and screw threads that have been manipulated to produce nanoscale electrochemically treated surfaces with a controlled nanotopography composed of nanotube arrays with a pore size diameter of 30 to 90 nanometers. In addition, calcium and phosphate are incorporated into the nanotube surface.

“This technology uniquely offers comparative data in the label assessing the relative performance of both human osteoblasts and human mesenchymal stem cells on our bioceramic nanotube surface against both conventional and micron rough titanium surfaces, with or without an acid etched nanoroughness, and with or without a calcium phosphate coated surface,” said Matt Hedrick, CEO of Nanovis. “We are particularly grateful to our scientists and innovative surgeon partners for guiding this technology to the market where it can benefit patients.”

“Surgeons and distributors have been very complementary of the nanotechnology benefits of our Nano FortiCore interbodies and have requested to pair them with nanotechnology enhanced pedicle screws,” said Jeff Shepherd, VP of Sales at Nanovis. “We plan to offer a complete portfolio of nanotechnology enhanced pedicle screw systems to include open, percutaneous, midline, and deformity, to give patients the most advanced technology possible.”

Pedicle screws provide a means of gripping a spinal segment. The screws themselves do not fixate the spinal segment, but act as firm anchor points that can then be connected with a rod. The screws are placed at two or three consecutive spine segments and then a short rod is used to connect the screws; this construct prevents motion at the segments that are being fused. After the bone graft grows, the screws and rods are no longer needed for stability and may be safely removed. However, most surgeons do not recommend removal unless the pedicle screws cause discomfort for the patient.

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