Icotec receive FDA clearance for pedicle screw system

Written by Alan Condon | July 11, 2019 | Print  |

The FDA granted icotec clearance for its VADERone pedicle screw system for use in minimally invasive and open spine surgical procedures.

Three insights:

1. VADERone consists of icotec's BlackArmor carbon/PEEK material, which is designed for secure stabilization and postoperative visualization.

2. The carbon/PEEK material is made up of carbon fibers blended with PEEK, which is generated using the company's injection molding composite flow molding technology.

3. This enables 3D reinforced, nonmetallic implants to offer the strength and radiolucency required for the treatment of oncology patients.

"Our ability to use icotec's BlackArmor material for stabilizing the spine offers advanced-stage tumor patients the ability to consider a larger variety of treatment options with improved therapy planning, dose delivery and follow-up evaluation," says Roger Stadler, CEO of icotec.

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