US-based Crosstrees Medical has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the Crosstrees PVA pod system for percutaneous vertebral augmentation (PVA).
The FDA approval for the CE marked Crosstrees PVA pod system is based on a prospective, single-arm IDE study, which showed significant reduction in pain scores and polymethyl methacrylate (PMMA) bone cement extravasation over a follow-up period of 12 months.
A total of 135 patients have been enrolled in the IDE study in the US, China, Venezuela and Belgium, and the patient outcomes for the Crosstrees procedure were compared to a literature control that included vertebroplasty and kyphoplasty outcomes.
The Crosstrees Pod technology was designed to control PMMA bone cement delivery and decrease the risk of complications such as nerve root compression and pulmonary embolism, caused by PMMA leakage.
In addition, the Crosstrees Pod technology’s novel approach to percutaneous vertebral augmentation has been demonstrated to reduce new vertebral fractures post treatment where literature reported rates range from 23%–48%.
Crosstrees procedure also showed significant reduction in new fracture rates frequently found with vertebroplasty and kyphoplasty procedures.
The Crosstrees Pod technology using devices include a polymer material for controlling the delivery of a specific volume and geometry of PMMA bone cement to the vertebral fracture site.
After the delivery of PMMA, the construct is opened and removed from the vertebra so that only the PMMA filler material remains in the treatment site.