Limacorporate SpA, a global orthopaedic company focused on digital innovation and patient-tailored hardware, and Orthofix Medical Inc, a global medical device company with a spine and orthopedics focus, announced a licensing partnership for the US market to provide a novel solution for patients with the challenging condition of chronic high dislocation of the hip.
The partnership combines the unique limb-lengthening technology of Orthofix's patented Fitbone intramedullary nail system with LimaCorporate's proprietary, patient specific, 3D-printed pelvic fixation device. Once surgically implanted, the devices work together with the aim of allowing surgeons to distract the femur to an anatomically-correct position thereby correcting the leg-length discrepancy, reducing strain on the spine, and allowing for a total hip replacement to follow.
"We are excited to partner with LimaCorporate to bring together our complementary technologies to satisfy the previously unmet needs of patients requiring a personalized and unique complex hip replacement solution," said Kimberley Elting, president of Orthofix Orthopaedics. "This solution will be the only offering in the US for certain patients with hip dysplasia or abnormalities of the hip leading to leg-length discrepancy, and reflects the strength and versatility of the Fitbone platform."
"This new solution to treat chronic high hip dislocation is not currently cleared by the US Food and Drug Administration (FDA) and is only available through an FDA Compassionate Use Exemption," added Elting.
Emmanuel Bonhomme, LimaCorporate CEO, stated, "This partnership is an important opportunity for us to explore new segments and support even more US surgeons and their patients. Additionally, the collaboration with the ProMade Point of Care Center (PoC Center), which opened last year, will bring added value in terms of experience and knowledge combined with our market-leading technologies in custom prosthesis."
LimaCorporate's ProMade 3D-printed custom service, which incorporates design and manufacturing in its unique PoC Center, is located at the main campus of Hospital for Special Surgery (HSS) in New York City.
"This new treatment method has shown compelling results demonstrating improved patient outcomes in this challenging cohort, and I am pleased to see this procedure now being made available to surgeons in the US," said Professor Rainer Baumgart, M.D., the surgeon-inventor of the Fitbone limb-lengthening system.
The Fitbone system consists of the implanted intramedullary nail, a subcutaneously implanted receiver, and an external control set that enables the patient or their caregiver to manage the distraction phase at home. The system is designed to provide accurate and controlled limb lengthening, with more than 3,500 cases performed in 15 countries since its development. With appropriate preoperative planning, it allows achievement of axial and torsional bone alignment intraoperatively, as part of the limb-lengthening procedure.
The Fitbone intramedullary lengthening system is available through a US Food and Drug Administration 510(k) clearance and in European Countries under the CE Mark approval.
