Medtronic plc has gained U.S. FDA 510(k) clearance of the CD Horizon® Fenestrated Screw Set, which can be used for patients diagnosed with advanced stage tumors involving the thoracic and lumbar spine. This marks the first U.S. clearance for cement-augmented pedicle screws.
60-80% of cancer patients, most frequently those with primary malignancies of the breast, prostate, liver, and lung, will suffer from metastatic bone disease, most commonly in the spine, where tumors can have a devastating effect. Cement-augmented screws represent an important palliative option by restoring spinal stability in patients whose life expectancy is insufficient to allow for fusion to occur.
The CD Horizon Fenestrated Screws are used with Medtronic’s HV-R® Fenestrated Screw Cement, a polymethylmethacrylate (PMMA) cement, and are intended for use at spinal levels where the structural integrity of the spine is not severely compromised. The set features cannulated pedicle screws designed with six fenestrations located near the end of the screw, allowing controlled cement injection into the targeted vertebral body after having placed all of the screws. This self-curing PMMA cement provides immediate screw fixation in the patient’s spine and significantly increases the screw pull-out strength compared to standard screws, according to cadaver studies. The cement is injected through a continuous tract in the adapter and into the screw cannula. This continuous tract delivery system is designed to have a completely secure channel that can be visually verified outside the patient to help reduce the likelihood of cement leakage at the adapter/screw interface while being compatible for minimally invasive surgery (MIS) and open procedures.
Following FDA clearance, Medtronic says The CD Horizon Fenestrated Screw Set will be available this fall.
“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,” said Francis H. Shen, M.D., orthopedic surgeon, Charlottesville, Va. “When placed into compromised bone, traditional screws run the risk of loosening over time. 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.”
“Palliative care is important for people with cancer, and Medtronic’s cement-augmented screws are a meaningful innovation that are designed to restore the integrity of the spinal column in patients with debilitating spinal tumors,” said Doug King, senior vice president and president of Medtronic’s Spinal division, which is part of the Restorative Therapies Group at Medtronic. “The availability of our CD Horizon Fenestrated Screw Set represents an important advance for surgeons and provides them with another option for a complex procedure.”
Source: Medtronic, plc