U.S., Europe Approve Two KONG VBR Spinal Systems From icotec

Swiss company icotec ag announced that its KONG-TL and the KONG-C vertebral body replacement systems with the titanium coating (Ti-iT) have received U.S. Food and Drug Administration 510(k) clearance in the United States and CE approval in Europe.
 
“This is exciting news for icotec ag and our team as it allows us to expand our portfolio in multiple countries simultaneously, to include implants made from radiolucent, nonmetallic BlackArmor® material with a 360 degree osseoconductive Ti-iT pure titanium coating,” said Roger Stadler, CEO of icotec ag.
 
The surgical replacement of vertebral bodies is a common procedure after the removal of tumors from the spinal column or after a serious spinal fracture. A vertebral body replacement implant (VBR) is used to reconstruct and stabilize the spinal column. The surgical requirements for these stabilization procedures are met by the broad, innovative and technology platform developed by icotec ag.
 
The fully modular design of these VBR systems with endplates in various profiles, sizes, angles and alignments complements the expandability afforded by the KONG-TL VBR E (thoracolumbar) for the thoracic and lumbar spine providing surgeons with a great deal of flexibility in the surgical planning process. With the KONG-C VBR for the cervical spine, the curved implant body ensures optimal adaptation to the anatomy of the patient.
 
The 360-degree Ti-iT pure titanium coating from icotec ag allows for the rapid engraftment of bone onto the implant thanks to the optimized osseoconductive structure.
 
The unique icotec BlackArmor Carbon/PEEK implant material enables artefact-free imaging to be carried out and, most notably, the improved planning, application, and follow-up care of radiotherapy for patients with tumors.
 
In March, the AO Foundation and icotec ag kicked off 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.