Bone loss treatment device gets approvals

April 9, 2019 0 By FM

NuVasive received 510(k) clearance from the US FDA as well as European CE mark approval for its Precice Bone Transport System for use in segmental bone loss treatment in the tibia and femur resulting from trauma or infection.

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. Following 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.

It 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.

Indications for the Precice Bone Transport System include treatment of acute bone defects up to 10 centimeters. The stainless-steel device provides the strength and stability needed to treat more complex segmental defects due to trauma or infection including infected non-unions, segmental defect and chronic bone infections.