Swiss medical device manufacturer icotec ag has received 510(k) clearance from the US Food and Drug Administration (FDA) for its extended VADER Pedicle System.
The approval is granted for the VADER Pedicle System inclusive of Ø 4.5mm pedicle screws along with extended long Carbon/PEEK rods made from BlackArmor.
The extended system can be used in open, minimally invasive surgery (MIS) and cement-augmented surgical techniques. It also offers additional options for stabilising the upper-thoracic region of the spine.
The system now features pedicle screws with diameters between 4.5mm and 7.5mm in lengths of 25mm to 60mm. Rods in different shapes and up to 300mm in length are also included.
BlackArmor Carbon/PEEK composite material is used to produce the VADER screws and rods.
BlackArmor is completely radiolucent and enables clear visualisation in postoperative imaging, enhanced radiation planning and dose delivery.
Furthermore, the composite material helps expand treatment options for patients with spinal tumours.
icotec CEO Roger Stadler said: “We are extremely proud that icotec is the world-leading provider of extended solutions for the stabilisation of this frequently affected spinal region with the extension of its VADER product family with canulated and fenestrated Ø 4.5mm pedicle screws and longer rod options.
“An important milestone that represents our continued commitment to develop and commercialise spinal implants made from radiolucent BlackArmor, expanding treatment options and allowing for safer tumour care.”
Established in 1999, icotec is engaged in the development, manufacturing and distribution of spinal implants made from artefact-free BlackArmor.
Processed using the company’s unique manufacturing technology, the BlackArmor material is composed of continuous carbon fibres combined with PEEK.