AO Foundation, icotec Partner on New Spinal Stabilization System

The AO Foundation and icotec ag announce the successful agreement and kick-off for the joint development of a new spinal stabilization system based on icotec’s proprietary BlackArmor Carbon/PEEK composite implant material.
 
“The AO is delighted to partner with icotec ag, and to leverage its game changing technology platform based on its unique BlackArmor material,” Dr. Maarten Spruit, chair of the AO Technical Commission Spine, explained. “Patients, surgeons, and radio-oncologists depend on artefact-free imaging, accurate radiation therapy, and reliable post-operative follow-up for the optimal treatment of spinal tumors and metastases. These interventions are often compromised by metal implants.”
 
Image artefacts of metal implants in different imaging modalities such as X-ray, computed tomography, and magnetic resonance imaging are a well-known obstacle in patient follow-up. When using non-metallic BlackArmor Carbon/PEEK implants, patients suffering from spinal tumors can be considered for a larger variety of treatment options with improved therapy planning, radiation dose delivery, and follow-up evaluation after separation surgery and stabilization.
 
Roger Stadler, CEO of icotec ag, pointed out the value of this partnership for its key projects: “Innovation translation at the AO is rooted in the AO’s Technical Commissions, which harness the profound expert knowledge of globally leading spine surgeons. They offer unparalleled knowhow to guide technologies from the concept stage throughout the entire lifecycle.”
 
Last summer, icotec AG received U.S. Food and Drug Administration (FDA) 510(k) clearance for both minimally-invasive and open spine surgical procedures with its VADER one pedicle screw system. VADER one, made from icotec’s unique BlackArmor material, was designed for secure stabilization and post-operative visualization, which is important after spinal tumor procedures.
 
VADER one is made from icotec’s unique BlackArmor Carbon/PEEK material, which consists of continuous carbon fibers combined with PEEK (polyetheretherketone), and is produced using icotec’s injection molding CFM (composite flow molding) manufacturing technology. This process allows for 3D reinforced, nonmetallic implants providing both, the strength and radiolucency needed for oncology patients and their treatment.
 
icotec is the only company manufacturing spinal implants made of radiolucent BlackArmor Carbon/PEEK composite material. Implants made of BlackArmor are biocompatible and have been successfully implanted for over 15 years. Their X-ray, CT and MRI translucency makes a significant difference during the surgical procedure, and postoperatively in assessing the site of care. In patients with spinal tumors, optimal delineation of the tumor from healthy tissue can facilitate radiotherapy planning, improve radiosurgery treatment and allow immediate and precise monitoring of possible relapses (tumor recurrence).
 
“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,” said Stadler.
 
The VADER one implants are 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 is of insufficient duration to permit achievement of fusion.