Pedicle Screw Study Launched (written by Biloine Young @ OTW)
Expanding Orthopedics Inc. (EOI), based in Israel, has launched a post-market study in Europe of its XPED Expanding Pedicle Screw System for spinal fusion. Up to 50 patients will be enrolled in the multi-center study which will be led by the spine team of Stauferklinikum in Germany. Participants will be followed for up to 24 months using quality-of-life questionnaires and radiographic assessments. The study is designed to assess the performance and usability of EOI’s Expanding Pedicle Screw System.
According to the company announcement, the XPED Pedicle Screw System is a complete spinal implant system including both standard and expandable pedicle screws along with the necessary instrumentation. The system is designed to provide greater fixation in various bone conditions as an adjunct to spinal fusion of the thoracic, lumbar, and sacral spine.
The XPED screw has an expandable 4-wing design that company officials believe increases the contact area with the bone, thus facilitating improved bone anchoring and natural bone in-growth. The XPED Pedicle Screw System is CE marked and commercially available across Europe.
“Initial anchoring and long-term fixation of the pedicle screw within the vertebral body are crucial for successful spinal fusion”, said Ronald Rissel, M.D., Head of Spine Center, Stauferklinikum, and Mutlangen, Germany, the October 3 press release. “A growing number of our patients undergoing spine fusion surgery suffer from an impaired bone condition as a result of chronic diseases, an unhealthy lifestyle and aging spine. In these patients, standard pedicle screws are sub-optimal, leading to a higher risk of screw loosening and resulting in a high re-operation rate. I expect the XPED expandable screw’s innovative design to provide enhanced anchoring and potentially improve patient outcomes.”
“We are honored to have one of the leading European centers in the field of orthopedics take part in this study” said Mr. Ofer Bokobza, CEO of Expanding Orthopedics Inc. “Up to 20% of patients undergoing spinal fusion with pedicle screws can benefit from the XPED Pedicle Screw System, which represents a worldwide market potential of about $1B. We expect the XPED Pedicle Screw System to improve surgery outcomes and significantly increase quality-of-life of treated patients.”
Expanding Orthopedics Inc. is a privately owned company that owns a broad patent portfolio covering the XPED and additional spine and orthopedic applications.