X-Bolt Orthopedics, an emerging innovator of orthopedic trauma devices, announced the successful completion of the first U.S. implant using its Pro-X1® Trochanteric Nailing System in Florida. This milestone marks the official commercial launch of the company’s flagship product and signifies a major step forward in applying X-Bolt’s technology for hip fracture treatment across the U.S.
The Pro-X1® system offers stronger anchorage and rotational stability in osteoporotic hip fracture fixation compared to traditional screw-based methods. This is especially beneficial for frail, elderly patients, as the expanding bolt provides superior fixation, addressing one of the major challenges in hip fracture treatment.
The Pro-X1® system builds on the company’s pioneering work in hip fracture treatment. The expanding bolt design, which first generation was clinically proven in the largest-ever hip fracture randomized controlled trial, with the lowest-ever cut-out rate published for hip fractures at 0.8%. This represents a breakthrough in orthopedic trauma care, where existing solutions rely heavily on screw-based fixation methods that can be limited in terms of stability, particularly for patients with fragile bone structures.
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Commenting on the milestone, Dr. Brian Thornes, X-Bolt’s founder and previous inventor of the globally recognized TightRope®, said: “Orthopedic trauma has seen the treatment of ankle injuries revolutionized with the TightRope suture-button, and should expect to see a similar paradigm shift now in the treatment of hip fractures with our expanding bolt and the Pro-X1® system. Hip fractures affect over 200,000 patients annually in the U.S., and this will bring a much-needed advancement in patient care.”
The Pro-X1® Trochanteric Nailing System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in 2023, and the completion of this first U.S. surgery marks the beginning of a limited commercial release. X-Bolt plans to scale its operations in the coming months, deploying additional inventory and expanding its reach to more markets across the United States. Following this launch, X-Bolt will continue to innovate and broaden its product line to apply its expanding bolt technology to more orthopedic trauma indications.
SOURCE: PRNewswire