CarboClear® cleared by the FDA to be used in the United States
CarboFix Orthopedics Ltd., is pleased to announce that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for the CarboClear® Carbon Fiber Pedicle Screw System, a novel device to surgically treat oncological patients in the United States. The CarboClear® Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced-stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The CarboClear® system provides unique clinical advantages to spine cancer patients and their physicians. Among those advantages are: no backscattering during radiotherapy (including particle therapy), which allows the use of radiation therapy without harming the healthy surrounding tissue; minimal attenuation of External Beam Radiation (EBRT), allowing radiation to pass through the implant with almost zero reduction in the radiation dose level; and no artifact in CT, for optimal radiation CT planning. CarboClear® spinal implants also offers superior fatigue strength, beneficial for a patient population known for extended delays in healing. Additionally, the CarboFix implants offer enhanced follow up abilities due to minimal artifacts during CT/MRI scans, facilitating early detection of possible tumor recurrence.
Dr. Stefano Boriani, head of oncological spine surgery of GSpine4 at the Galeazzi Institute Milan, Italy, said about his clinical experience with the CarboClear® system: “This unique material provide 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.”