CarboFix wins FDA nod for its carbon/PEEK pedicle screws

CarboFix Orthopedics Ltd. has won FDA approval for a spinal screw system for use in people with advanced spinal cancer.

The CarboClear carbon fiber pedicle screw system was designed to restore the integrity of the spinal column, even in the absence of fusion, for a limited time period in patients with advanced-stage thoracic and lumbar spine tumors. The screw system will hold the spine securely until patients are able to undergo spinal fusion, according to the Herzeliya, Israel-based company. The FDA gave the system 510(k) clearance.

CarboClear pedicle screws are made of continuous carbon fibers reinforced polymer (PEEK). The PEEK adheres the fibers together, and the continuous carbon fibers are layered in a unidirectional, longitudinal orientation, as well as in helical/diagonal orientation, according to the company’s website. The material makes the CarboFix implants radiolucent, which is beneficial during surgery and follow-up.

This composite material enables MRI & CT scans with no or minimal artifact for better soft-tissue visualization. It also enables radiation therapy with no scattering of radiation beams to harm nearby healthy tissue. Radiation beams can pass through the implant with almost zero reduction in the radiation dose level, the company said. The spinal screws offer superior fatigue strength, which benefits a patient population known for extended delays in healing.

For spinal tumor treatment, radiation therapy plays an important role in pain management, the local treatment of spinal tumors and the prevention of pathologic fractures. Before administering radiation therapy, the radiologist relies on accurate CT or MRI images to plan the radiation dose. However, when metal spinal implants are present, these implants can cause artifact on the planning images. This artifact makes it more difficult to delineate anatomic structures during radiation therapy planning and correctly calculate the proper dose distributions.

During radiation therapy, metal spinal implants may also shield remaining tumor cells from the curing radiation. In addition, metal implants induce scattering of the radiation beams into the surrounding soft tissue potentially causing side effects. Some patients who have metal implants may not be candidates for radiation therapy, according to a 2010 study of scattering effects of irriadiation published in Anticancer Research. 

Bone is the third most frequent site of metastasis, behind lung and liver, according to Bone Metastases: An Overview, published in 2017 in Oncology Reviews. Bone metastases are a major cause for morbidity, characterized by severe pain, impaired mobility, pathologic fractures, spinal cord compression, bone marrow aplasia and hypercalcemia, the article says.

Stefano Boriani, MD, head of oncological spine surgery of GSpine4 at the Galeazzi Institute Milano, has used the CarboClear system with patients. “This unique material provide(s) us with additional treatment options that we didn’t have in the past, and in our experience provides better clinical outcomes for the treated patients,” Boriani said in a CarboFix news release.

icotec AG debuted its radiolucent pedicle screw system for spinal cancer patients in 2015.

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