The VADER Pedicle System Navigated Instruments combine standard surgical processes with advanced navigational tools to ensure that treatments adhere to industry standards and provide optimal results to the patients
VADER Pedicle System Navigated Instruments gets FDA clearance. (Credit: PR Newswire/Icotec Medical)
Swiss medical device maker icotec has received the US Food and Drug Administration (FDA) 510(k) clearance for its VADER Pedicle System Navigated Instruments.
The company said that the regulatory milestone marks an important step forward in improving surgical precision and safety for spine surgeons using its BlackArmor Carbon/PEEK implants.
The VADER Pedicle System Navigated Instruments combine standard surgical processes with advanced navigational tools to ensure that treatments adhere to industry standards and provide optimal results to the patients.
According to icotec, the latest navigation set also has a wide variety of equipment for both open surgery and minimally invasive surgery.
By giving surgeons more precision and accuracy during procedures, this expanded portfolio enables them to produce better results for their patients, said the Swiss medical device company.
Icotec CEO Roger Stadler said: “Receiving FDA 510(k) clearance for our navigated instrumentation is a significant achievement for icotec. We are proud to offer our surgeons the tools they need to perform these procedures with the utmost precision and confidence.
“This clearance opens new opportunities for growth and reaffirms our position as the leader in Carbon/PEEK implants and our commitment to keeping a standard surgical technique.”
In late 2020, the VADER pedicle system secured the FDA 510(k) clearance for use with bone cement for augmentation or without.
In January 2023, icotec received the FDA 510(k) clearance to market the VADER pedicle system inclusive of Ø 4.5 mm pedicle screws along with extended long Carbon/ PEEK rods made from BlackArmor.
Founded in 1999, the Swiss medical device maker focuses on the spinal implantation field.