icotec ag Announces the Market Launch of its BlackArmor® Anterior Cervical Plate in the Unites States
January 27, 2021 – Altstaetten, Switzerland – icotec ag, a leading medical device manufacture of BlackArmor® Carbon/PEEK implants, announces the United States market release of the world’s first 100% nonmetallic (Plate and Screws) Anterior Cervical Plate System after recently receiving U.S. Federal Drug Administration (FDA) 510(k) market clearance and after over one thousand successful implantations in Europe over the past several years.
The icotec Anterior Cervical Plate System is made completely of icotec’s proprietary BlackArmor® Carbon/PEEK material. It is the only 100% nonmetallic and radiolucent Anterior Cervical Plate System with a plate AND SCREWS made of Carbon/PEEK available in the United States.
“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 tumors, be restored completely with 100% nonmetallic implants, which offers potentially significant additional treatment options for tumor patients,” said Roger Stadler, CEO of icotec ag.
The icotec Anterior Cervical Plate System is intended to restore the integrity of the cervical spinal column in patients with advanced stage spinal tumors. The System’s Carbon/PEEK design assists in reducing artifact in post-operative imaging to benefit future assessment and treatment of the surgical area. The Carbon/PEEK material also has mechanical properties that provide for less stress shielding at the implantation site. The Anterior Cervical Plate System features pre-contoured plates that adapt to the patient’s cervical anatomy in sizes between 21 and 94mm to span between 1 and 4 spinal segments. It also contains bone screws in multiple diameters and lengths.
icotec’s Anterior Cervical Plate System is ready to be used in first surgeries in the United States.
ABOUT ICOTEC AG
Founded in 1999, icotec ag is a family-owned SME based in Altstaetten, Switzerland. icotec develops, manufactures, and distributes nonmetallic spinal implants made from BlackArmor®. icotec’s proprietary BlackArmor® material is made up of continuous carbon fibers combined with polyether ether ketone (PEEK) and is manufactured with icotec’s unique injection molding CFM (composite flow molding) manufacturing technology.
With over 15 years of clinical success and more than 40,000 implanted products made from the unique BlackArmor® material, icotec ag is the leading provider of Carbon/PEEK spinal implants.