Medtronic Gets First-Ever FDA Approval for Cement-Augmented Pedicle Screws

Medtronic plc

revealed that the Food and Drug Administration (FDA) has approved its CD Horizon Fenestrated Screw Set, which could be used for patients diagnosed with advanced stage tumors involving the thoracic and lumbar spine. According to the company, this marked the first approval for cement-augmented pedicle screws in the United States. The company indicated that its CD Horizon Fenestrated Screw Set would be available this fall. Medtronic said that the CD Horizon Fenestrated Screws were used with its HV-R Fenestrated Screw Cement, a polymethylmethacrylate (PMMA) cement, and were planned for use at spinal levels. The company added that the structural integrity of the spine was not severely compromised in the spinal levels. Orthopedic surgeon, Francis Shen, commented, "Current cancer treatments can weaken a patient's bones and primary malignancies often spread to the spine, which cause considerable pain and are complex to manage. When placed into compromised bone, traditional screws run the risk of loosening over time." He continued to add, "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 to mobilize my patients more quickly." The company indicated that Metastatic bone disease was reported to happen in 60-80 percent of cancer patients. This was a frequent thing among those with primary malignancies of the breast, prostate, liver, and lung. The medical device maker said that the spine was the most common site of bone metastasis and could be impaired by metastatic bone tumors. The company added that the Cement-augmented screws were meant to restore spinal stability in patients whose life expectancy was not sufficient to enable fusion to occur. On Wednesday, the stock advanced 0.40 percent.