Icotec AG received FDA approval for its Vader Pedicle System for use with or without bone cement augmentation, the company announced Nov. 10.
The Vader Pedicle System temporarily restores integrity to the spinal column without fusion for patients with advanced stage tumors in the thoracic or lumbar spine. The system is designed as a fusion alternative for patients who aren't stable enough to undergo a fusion procedure.
Roger Stadler, Icotec CEO, said, "We are so proud to present today the Vader product family which represents our continued commitment to develop and commercialize spinal implants made from our radiotransparent, nonmetallic BlackArmor material that produces minimal image artifact while eliminating shielding and scattering of radiation during oncology treatments."
It's unclear when the company will start commercialization efforts.