Spine technology company NuVasive Inc (NASDAQ:NUVA) revealed on Monday that it has received US Food and Drug Administration (FDA) 510(k) clearance as well as the European CE mark approval for use of its Precice Bone Transport System for the treatment of segmental bone defects up to 10 centimetres in the tibia and femur.
The company added that the Precice Bone Transport System is the only all-internal system of its kind on the market indicated for use in segmental bone loss treatment in the tibia and femur resulting from trauma or infection. The Precice Bone Transport System is expected to launch commercially in the US and Europe in third quarter 2019.
Following the approvals, the Precice Bone Transport System now joins the company's NuVasive Specialized Orthopedics (NSO) family of advanced, magnetically adjustable limb-lengthening products, which have collectively been used to treat thousands of patients.
According to the company, the Precice Bone Transport System includes an implantable, magnetic intramedullary nail with a dual slot designed to support the transport of an intercalary bone segment to facilitate healthy regeneration. Upon implantation, an external remote controller is used to precisely move the bone segment up to 10 centimetres based on the specific needs of each patient.
In conjunction, the company's Precice Bone Transport System provides an all-internal solution compared to traditional external fixation systems, which require patients to wear an external device for an extended period of time, with the potential for increased pain and risk of infection. The stainless steel device provides the strength and stability needed to treat more complex segmental defects due to trauma, infection, infected non-unions, segmental defect as well as chronic bone infections.
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