icotec's CMORE® CT System Receives FDA Approval, Enhancing the BlackArmor® Technology

icotec Achieves Milestone with FDA Clearance for CMORE® CT System

In a remarkable achievement for medical innovation, icotec, renowned for its groundbreaking work in implantable medical devices, has received FDA clearance for its CMORE® CT System. This approval enhances icotec's BlackArmor® Engineered Carbon/PEEK technology, enabling its application in the posterior cervical and thoracic spine.

The CMORE® CT System is a revolutionary instrument and implant portfolio designed for posterior stabilization of the upper spine. Distinctively, it features the world's first vertebral implants made from a non-metallic, radiolucent BlackArmor® material, which significantly expands treatment options in adjuvant tumor therapies while improving post-operative imaging capabilities for the cervical and thoracic regions. By offering comprehensive solutions that are tailored to a variety of anatomical and pathological conditions, icotec empowers surgeons to enhance patient outcomes.

The core of the CMORE® CT System comprises a diverse range of polyaxial screws, straight and pre-shaped rods, as well as axial and parallel connectors, providing the necessary versatility to meet the unique needs of each patient. The BlackArmor® Engineered Carbon/PEEK combines continuous, high-strength carbon fibers with PEEK, created from a proprietary process developed by icotec. This results in a uniquely interwoven 3D fiber architecture, ensuring the implants are radiolucent across various imaging modalities including MRI, CT, and X-ray, making them an invaluable tool for medical professionals.

Christoph Eigenmann, CEO of icotec Medical USA, commented, "The FDA's approval of the CMORE® CT System represents a significant milestone in our commitment to enhancing 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 greater clarity and safety in their postoperative and oncological decisions."

With this FDA clearance, icotec prepares for the anticipated market launch of the CMORE® CT System in the United States—a pivotal step that broadens icotec’s portfolio of BlackArmor® Engineered Carbon/PEEK implants designed for artifact-free imaging and seamless integration throughout the spine.

About icotec

As a leader in the treatment of spinal tumors and other indications with next-generation high-tech implants, icotec merges advanced technology with industry expertise to provide innovative solutions for spinal surgeons and their patients. With a proven track record of clinical successes and a commitment to ongoing innovation, icotec is poised to shape the future of spinal surgery. Its extensive product portfolio has secured both FDA and CE approvals and is endorsed by numerous leading experts and spinal surgery centers worldwide.

For more information about icotec and its groundbreaking products, visit icotec-medical.com.

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Craig Wencis
Senior Vice President of Marketing and Education
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This new achievement underscores icotec’s mission to lead advancements in spinal health technologies, ensuring patients have access to the best possible care.