Stryker’s VertaPlex HV becomes first PMMA to receive clearance for treating sacral insufficiency fractures

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In 2008, Stryker released VertaPlex with the aim of addressing specific viscosity and working time preferences for treating vertebral compression fractures. In 2015 it received 510(k) clearance for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. VertaPlex HV was the first PMMA to receive this.

“Careful intraoperative technique and VertaPlex HV PMMA is an excellent and safe solution in the management of sacral fractures.” says Jeffrey W. Miller, MD, Director of Neuroendovascular Surgery at Bronson Methodist Hospital in Kalamazoo, Michigan, and principal investigator of the Stryker sponsored study for 510(k) submission. “I have already witnessed dramatic patient improvement in my own practice by incorporating sacral vertebroplasty/sacroplasty as part of my intraoperative protocol.”

Due to the inherent porosity of sacral bone and comorbidity of osteoporosis, cement extravasation may be a risk for treatment of sacral insufficiency fractures. As reported in Spine, in this porous, osteoporotic environment, higher viscosity cement can help reduce cement spreading and forming denser cement clusters.

“As our population ages, we will see more sacral insufficiency fractures that will require intervention,” saya Douglas Yim, visiting associate professor, associate program director of interventional radiology at Johns Hopkins School of Medicine, Baltimore, Maryland.