FDA Clears Stryker’s VertaPlex HV
The FDA has granted clearance to the Interventional Spine business unit Stryker’s Instruments division to market its expanded indications of VertaPlex HV for the treatment of sacral insufficiency fractures.
The diagnosis of sacral insufficiency can be difficult because the radiographic assessment of the sacrum is complicated, resulting in an under diagnosed condition for the elderly population, Stryker says. Additionally, lower spine imaging is often not specifically targeted at the sacrum.
Sacral vertebroplasty involves the injection of bone cement into the sacrum to make the pain less severe.
VertaPlex HV was released in 2008 to address specific viscosity and working time preferences for treating vertebral compression fractures. — Michael Cipriano