Medtronic received the first-ever FDA clearance for cement-augmented pedicle screws in the CD Horizon Fenestrated Screws.
Here are five things to know about the technology:
1. The CD Horizon Fenestrated Screw Set is used with the HV-R Fenestrated Screw Cement, a polymethylemetacrylate cement intended for use at spinal levels where structural integrity isn't severely compromised.
2. The system is designed for patients with advanced spinal tumors in the thoracic and lumbar spine.
3 The screw set includes cannulated pedicle screws with six fenestrations near the end of the screw, allowing for controlled cement injection into the targeted vertebral body. The PMMA is self-curing for immediate screw fixation and significantly increases screw pull-out strength compared to standard screws.
4. The cement is injected through a continuous tract in the adapter and into the screw cannula to reduce cement leakage at the adapter/screw interface.
5. The technology is compatible for minimally invasive and open procedures.
"When placed into the compromised bone, traditional screws run the risk of loosening over time," said Francis H. Shen, MD, an orthopedic surgeon in Charlottesville, Va. "The ability to utilize cement augmentation directly through a fenestrated screw is a great advancement. It allows me to achieve immediate implant stability which would not be possible with traditional non-augmented screws. More importantly this allows me to help mobilize my patients more quickly."