Swiss device company, icotec AG, has history as a pioneer in the development of non-metallic Carbon/PEEK composite medical devices. Now, 15 years and 20,000 implants after its first use in spinal and fracture surgery, the company has announced the brand name of BlackArmor® for what it clearly believes represents the future core material for use in load-bearing surgical devices.
Background
It certainly has that “powertool” feel about it; 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 ideally suited for the treatment of spinal tumors for example. Here, accuracy in delivering radiation doses often demands CT imaging, which can be difficult to interpret when metal implants can throw off artifacts. Metal spinal implants may also shield tumor cells from the curing effects of 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.
Contrastingly, BlackArmor is radiolucent in all diagnostic imaging modes (MRI, CT and X-ray) and will therefore not create imaging artifacts. Furthermore 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.
Source: PR Newswire
published: September 29, 2016 in: Company News, Spine, Trauma