US-based Crosstrees Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Crosstrees PVA Pod System, designed to control bone cement delivery and decrease the risk of PMMA leakage associated with vertebroplasty and kyphoplasty, the standard surgical treatments for vertebral compression fractures.
The FDA approval was based on a prospective, single-arm investigational device exemption (IDE) study that enroled 135 patients with vertebral compression fractures in the US, China, Venezuela and Belgium.
The IDE clinical study was conducted to evaluate the performance of the Crosstrees Pod System in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty.
It reported promising results with significant reduction in pain scores and PMMA bone cement extravasation over a follow-up period of 12 months, following which the percutaneous vertebral augmentation (PVA) Pod System received FDA approval for the treatment of osteoporosis fractures of the vertebral body.
The 12-month IDE study outcomes also demonstrated superior pain relief and reduced new fracture rates in patients with osteoporotic compression fractures, where literature reported rates range from 23%-48%.
In addition, the Crosstrees procedure demonstrated an improved reduction in new fracture rates.
Devices using the Crosstrees Pod technology feature a polymer material to control the flow of bone cement as it is injected into the vertebral body.
Following PMMA delivery, the construct is opened and removed from the vertebra, so that only the bone cement remains in the treatment site.
Crosstrees Medical president and CEO Robert Scribner said Crosstrees PVA Pod System is now FDA-cleared and CE-marked, making a promising new treatment option available to patients with vertebral compression fractures.
"We believe that the Crosstrees POD technology offers the physician unprecedented control of PMMA delivery in vertebral augmentation and has demonstrated significantly improved procedural outcomes for patients," Scribner said.
The Crosstrees Pod System uses a fabric pod that eliminates the balloon inflation step required in traditional kyphoplasty procedures.
The CE-marked Crosstrees Pod system’s design simplifies the procedure and potentially cut-downs procedure time. It also minimises the need for repeated device exchanges during the procedure.
According to GlobalData estimates, orthopaedic bone cement and casting materials market in the US was valued at $600m in 2012 and is expected to grow at a CAGR of 7.2% to reach $974m by 2019.