icotec ag has announced the US market release of its BlackArmor carbon/PEEK implants. According to a company press release, it is the world’s first 100% non-metallic (plate and screws) anterior cervical plate system. The announcement comes after the device received 510(k) market clearance from the US Food and Drug Administration (FDA).
According to the company the icotec anterior cervical plate system is made completely of icotec’s proprietary BlackArmor Carbon/PEEK material. Additionally they claim that over one thousand successful implantations in Europe over the past several years.
“The icotec Anterior Cervical Plate System is the latest addition to our portfolio of implants made out of BlackArmor Carbon/PEEK. The icotec anterior cervical plate system ideally complements the previously introduced KONG-C VBR M vertebral body replacement system made of BlackArmor material and allows, for the first time, the integrity of the cervical spine in patients requiring surgery for advanced stage tumours, be restored completely with 100% non-metallic implants, which offers potentially significant additional treatment options for tumour patients,” said Roger Stadler, CEO of icotec ag, Altstaetten, Switzerland.
The company states the icotec anterior cervical plate system is intended to restore the integrity of the cervical spinal column in patients with advanced stage spinal tumours and the system’s carbon/PEEK design assists in reducing artifact in post-operative imaging to benefit future assessment and treatment of the surgical area. They further claim the carbon/PEEK material also has mechanical properties that provide for less stress shielding at the implantation site.
According to icotec ag, the anterior cervical plate system features pre-contoured plates that adapt to the patient’s cervical anatomy in sizes between 21mm and 94mm to span between one and four spinal segments, and it also contains bone screws in multiple diameters and lengths.