Stryker's Interventional Spine business received FDA clearance for its VertaPlex HV, which treats sacral insufficiency fractures.
Here are five things to know:
1. This device is the first PMMA to receive clearance for the fixation of pathological sacral fractures using sacral vertebroplasty or sacroplasty.
2. Stryker released its VertaPlex HV in 2008, which offered viscosity and working time preferences for vertebral compression fracture treatments.
3. Sacral vertebroplasty injects bone cement into the sacrum in hopes of reducing pain and allowing mobilization.
4. Diagnosing sacral insufficiency fractures proves challenging because lumbar spine imaging does not target the sacrum.
5. Cement extravasation is a possible complication with the procedure, so high viscosity cement helps limit cement spreading.
"As our population ages, we will see more sacral insufficiency fractures that will require intervention," said Douglas Yim, MD, visiting associate professor, associate program director of interventional radiology, Johns Hopkins Schools of Medicine. "Having a reliable and consistent high viscosity cement like VertaPlex HV will allow greater margin of safety for patients undergoing sacroplasty."