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Stryker Corporation, one of the world's leading medical technology companies instruments division of interventional spine business unit has received clearance from the US Food and Drug Administration (FDA) to market its expanded indications of VertaPlex HV for the treatment of sacral insufficiency fractures.
Sacral insufficiency fractures are an often under diagnosed condition in the elderly population, typically presenting with severe low back pain resulting in immobility. It is difficult to diagnose the sacral insufficiency fracture at an early stage. The precise incidence of the sacral insufficiency fracture is unknown.
Stryker set a new standard in 2008 with the release of VertaPlex HV, addressing specific viscosity and working time preferences for treating vertebral compression fractures. On June 12, 2015, VertaPlex HV became the first PMMA to receive 510(k) clearance for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty.
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