FDA Clears Novel System for When There’s No Time for Fusion

Some patients with advanced-stage tumors don’t have enough time to wait for a successful spinal fusion. For those patients, FDA 510(k) clearance of Swiss-based icotec AG’s Vader Pedicle System and bone cements may ease their remaining days.

No Time for Fusion

The system, according to FDA documents dated October 13, 2020, is intended to “restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.”

VADER Pedicle System

Vader “…is a posterior pedicle system manufactured from Carbon/PEEK using a proprietary manufacturing process and consists of polyaxial pedicle screws and curved, straight and J-rods as well as polyaxial, cannulated, fenestrated pedicle screws. The system can be used for single or multiple level fixations in the non-cervical spine.”

The fenestrated pedicle screws allow for bone cement augmentation to increase stability in patients with compromised bone and are used in conjunction with the company’s G21 V-Fast or V-Steady Bone Cement and PicoMix V and/or V-HP Gun with a cement cannula, which mix and inject the bone cement. The intended use is limited at spinal levels “where the structural integrity of the spine is not severely compromised.”

Bone Cements

FDA documents state the “V-Steady and V-Fast are polymethylmethacrylate (PMMA) based bone cements formulated to perform percutaneous vertebral augmentation procedures, such as vertebroplasty or kyphoplasty. Bone cements are self-curing systems consisting of liquid and powder components.”

V-Steady bone cement has an “immediate development of viscosity and thus it is a high viscosity cement that maintains its properties throughout the useful working time.” The V-Fast has a “low initial viscosity and a long working time allowing to work extremely carefully especially when a good time margin before polymerization is required.”

Surgeons have options with a minimally invasive and open approach for posterior spinal surgery.

icotec AG

icotec AG, established in 1999, is family-owned in Altstaetten, Switzerland. The company designs and manufactures nonmetallic spinal implants made from BlackArmor® (Carbon/PEEK). icotec’s proprietary BlackArmor® material consists of continuous carbon fibers combined with PEEK (polyether ether ketone) and is produced using icotec’s injection molding CFM (Composite Flow Molding) manufacturing technology.