Lenoss Medical
Medical Devices - Providence, Rhode Island, United States
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Vertebral Body Augmentation involves surgical placement of an instrument to create a cavity within a fractured vertebral body, due to trauma or osteoporosis. When the cavity is created, a device is implanted to fill the void and provide stability to damaged vertebrae.When a biologic is used to fill the cavity, a regenerative phenomenon occurs, new bone begins to grow – and gradual healing of the affected vertebrae is achieved.When a chemical epoxy is used to fill the cavity, no healing occurs, and the epoxy is left in the patient's vertebrae. Even though the synthetic technique is widely used in industry, there are a variety of complications. First, the epoxy is known to migrate outside the defined cavity (~23%) predisposing the patient to the risk of embolisms. Secondly, no healing occurs within the fractured vertebrae. Third, the vertebrae can no longer be instrumented with pedicle screws if/when the patient will need additional surgery. The inability to instrument a vertebra may result in a more invasive procedure with a myriad of complications and comorbidities. The time and temperature sensitivity of the epoxy, the toxic out-gassing, and numerous instrumentation also makes for an undesirable OR experience.
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