icotec Receives FDA Approval for CMORE® CT System, Transforming Spinal Surgery

icotec Receives FDA Clearance for the CMORE® CT System

In an exciting development for spinal surgery, icotec, a leader in implantable devices made from BlackArmor® composite carbon and PEEK (Polyether Ether Ketone), has obtained clearance from the U.S. Food and Drug Administration (FDA) for their innovative CMORE® CT system. This breakthrough expands the applicability of their cutting-edge technology to the posterior cervical-thoracic spine.

The CMORE® CT System

The CMORE® CT system introduces an upgraded set of instruments and implants designed specifically for posterior stabilization of the upper spine. Featuring the world’s first spinal implants made from BlackArmor® technology, which is not only non-metallic but also radiolucent, these innovations enhance both the therapeutic options available in adjuvant tumor therapy and the quality of postoperative imaging diagnostics in the cervico-thoracic region of the spine.

The system is equipped with a comprehensive selection of polyaxial screws, both straight and pre-contoured rods, as well as axial and parallel connectors. Such versatility ensures that this system can accommodate a variety of anatomical and pathological variations presented by patients, allowing for personalized surgical approaches.

The BlackArmor® Advantage

BlackArmor® composite carbon/PEEK is a unique material that combines continuous, high-strength carbon fibers with PEEK. This composite is engineered through a proprietary process developed by icotec, resulting in 3D interwoven fiber architecture that offers both strength and resilience. Moreover, this composite is radiolucent across all diagnostic imaging modalities, including MRI, CT scans, and X-rays, thus removing artifacts that might obscure crucial diagnostic information.

Christoph Eigenmann, CEO of icotec Medical USA, emphasized the significance of the FDA’s approval, stating, “The clearance of the CMORE® CT system marks another milestone in our commitment to advancing care for patients with spinal tumors, infections, and complex pathologies. By extending our BlackArmor® technology to the posterior cervical spine, we provide surgeons and radiation oncologists with a new level of visibility and confidence in their postoperative and oncological decision-making.”

The upcoming commercial launch of the CMORE® CT system in the United States is highly anticipated. It will broaden the scope of icotec's range of implants designed to offer artifact-free imaging and seamless integration within the spinal anatomy, further refining surgical outcomes.

About icotec

Headquartered in Altstätten, Switzerland, and with a foothold in Boston, Massachusetts, icotec is a pioneering company dedicated to the treatment of spinal tumors and other medical indications through its next-generation, high-tech implants. By combining state-of-the-art technologies with expertise in the field, icotec strives to deliver reliable and innovative solutions to spine surgeons and their patients.

With a focus on clinical success and a dedication to innovation, icotec is poised to lead the future of spinal surgery. Its complete portfolio of products has received regulatory approvals from both the FDA and the CE, and is supported by numerous opinion leaders and spinal surgery centers throughout the globe. The company's commitment to advancing spinal implant technology ensures better outcomes for patients facing complex spinal health challenges.