icotec AG Received FDA Clearance to Market BlackArmor® Carbon/PEEK Interbody Cages
June 12, 2018 - Altstaetten, Switzerland – icotec AG, a Swiss company, today announced that its latest line of interbody cages, designed to optimize bony integration and post-operative visualization has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The clearance includes cages for a variety of surgical approaches, such as cervical fusion procedures like Anterior Cervical Discectomy and Fusion (ACDF) procedures as well as lumbar procedures like Posterior Lumbar Interbody Fusion (PLIF) and Transforaminal Lumbar Interbody Fusion (TLIF) procedures.
All the interbody cages have, at their core, icotec’s unique BlackArmor® Carbon/PEEK material, which consists of continuous carbon fibers combined with PEEK, and are produced using icotec’s Injection Molding CFM (Composite Flow Molding) manufacturing technology. This process allows reproducible product quality with the consistent orientation of the continuous carbon fibers, resulting in unparalleled strength and mechanical durability while providing excellent imaging quality and a modulus of elasticity close to half that of titanium. All cages are circumferentially (360°) coated with a rough Ti-iT® titanium coating, which is applied using a VPS (Vacuum Plasma Spray) procedure. The Ti-iT® commercially pure titanium coating from icotec enables bony ongrowth to the implant. Bone tissue attaches and integrates safely into the surface of the implant due to the rough structure.
icotec is the only company manufacturing spinal implants made of nonmetallic, radiolucent BlackArmor® Carbon/PEEK composite material. Implants made of BlackArmor® are biocompatible and have been successfully implanted for over 15 years. Their X-ray translucency makes a significant difference during intra- or postoperative assessments of the site of care and for spinal fusion. Especially in patients with spinal tumors, optimal delineation of the tumor from healthy tissue can facilitate radiotherapy planning, optimize radiosurgery treatment and allow immediate and precise monitoring of possible relapses (tumor recurrence).
“Our ability to combine two unique technologies, BlackArmor® material and Ti-iT® coating, allows us to provide implants, that can truly make a difference for patients and their clinical outcome. With the combination of the two core technologies in our interbody cages, we see excellent fusion results without compromising the post-operative image quality”, said Roger Stadler, CEO of icotec AG in Switzerland. “Our focus has been on developing implants with comparable osseointegration and biomechanical strength to titanium while adding unparalleled postoperative X-ray, CT and MR imaging for any spinal pathology including but not limited to degenerative disc conditions and spinal tumor.”
The latest version of icotec’s cage line has been available in countries requiring CE Mark since 2011 and over 8,500 interbody cages have been successfully implanted to date. icotec cages will be widely available in the US starting in August 2018.
icotec will showcase its full line of cages at this year’s NASS convention from September 26-29 at the Los Angeles Convention Center - South Building, Los Angeles, California.