Swiss spinal implant company icotec AG announced on Tuesday that it has received US Food and Drug Administration (FDA) 510(k) clearance for the VADERone pedicle screw system for both minimally-invasive and open spine surgical procedures in oncology patients.
According to the company, VADERone was designed for secure stabilisation and post-operative visualisation, which is important after spinal tumour procedures. The VADERone 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 tumours involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
VADERone is made from icotec's unique BlackArmor Carbon/PEEK material, which consists of continuous carbon fibres combined with PEEK (polyetheretherketone) and is produced using its injection molding CFM (Composite Flow Molding) manufacturing technology.
The 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 tumours, optimal delineation of the tumour from healthy tissue can facilitate radiotherapy planning, improve radiosurgery treatment and allow immediate and precise monitoring of possible relapses, concluded the company.
FDA approval streamlines access to Bristol Myers Squibb CAR T cell therapies
Emmaus Life Sciences' Endari label enhancements receive US FDA approval
Accord Healthcare introduces Dehydrated Alcohol Injection for cardiovascular indications
CARsgen Therapeutics' satri-cel NDA accepted by Chinese regulator
Sanofi receives FDA orphan drug designation for riliprubart in transplant rejection
Hoth Therapeutics reports positive interim results for HT-001 topical therapy
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Hemab Therapeutics presents bleeding disorder clinical and preclinical data at ISTH 2025 Congress