ALTSTAETTEN, Switzerland, September 29, 2016 /PRNewswire/ —
icotec AG, an innovative medical device company leading the industry in the development and manufacturing of non-metallic Carbon/PEEK composite medical devices, announces the brand name of BlackArmor® for its Carbon/PEEK material, which boosts a 15 year and 20,000 implantation clinical track record in spinal and fracture surgical care.
BlackArmor is a combination of continuous, high-strength carbon fiber reinforced PEEK and the company’s composite flow moulding (CFM) process. The result is a medical device with an interwoven 3D fiber architecture that provides unmatched strength and endurance. icotec’s technology is an enabler for complex designs such as pedicle screws, vertebral body replacement devices or supplemental fixations devices, like anatomical bone plates. The combination of mechanical strength and non-metallic properties make BlackArmor also ideally suited for the treatment of spinal tumors.
In the case of spinal tumors, radiation therapy plays an important role in pain management and local tumor control after the surgical removal of the tumor and stabilization of the spinal column.
Before administering radiation therapy, the radiologist relies on accurate CT images to plan the radiation dose. However, the presence of metal spinal implants causes significant 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 tumor cells from the curing radiation. In addition, metal components induce scattering of the radiation beams into the surrounding soft tissue potentially causing side effects. In some cases, patients may not be candidates for proton radiation therapy because of the presence of metal implants.
BlackArmor is radiolucent in all diagnostic imaging modes (MRI, CT and X-ray) and will therefore not create imaging artifacts; a significant clinical benefit in the postoperative monitoring of anatomical structures. In addition, the non-metallic nature of the BlackArmor material minimizes the risk for patients where metal allergies are a potential concern.
Orthopedic implants manufactured from BlackArmor Carbon/PEEK material were approved for CE-mark in 2000 and received FDA clearance in 2005.
Founded in 1999, icotec AG has become a worldwide leader in the design, development and manufacturing of Carbon/PEEK composite to create high strength implants for loadbearing musculoskeletal applications. The company is headquartered in Altstaetten, Switzerland.