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About Compression Fractures

Vertebroplasty, Kyphoplasty and the Crosstrees System for PVA     back to main

In the past, patients and doctors had only two treatment options for vertebral compression fractures. Vertebroplasty is the direct injection of liquid bone cement into the fractured vertebral body. Kyphoplasty is a similar procedure but uses a balloon to create a cavity in the vertebral body before the cement is injected.

In both procedures, the bone cement then hardens, providing stabilization and pain relief. Because the bone cement is injected directly into the vertebral body, both treatments carry significant risk of the bone cement leaking from the vertebral body before it hardens. Cement leaks can result in neurological complications, emboli (blockages of blood vessels), or death.4

Crosstrees Medical has devised an alternative method of vertebral augmentation -- the Crosstrees System for PVA -- that is designed to provide the physician with greater control of cement placement than traditional treatment options for compression fractures. The Crosstrees System uses a soft woven fabric Pod that allows the physician to control the flow of bone cement as it is injected into the vertebral body.

The FDA has recently granted approval to Crosstrees Medical to conduct a clinical study of  market the Crosstrees System for Percutaneous Vertebral Augmentation (PVA) in multiple medical centers in the United States. The purpose of the study is to evaluate the performance of the Crosstrees System has been shown to be effective in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty.

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Intended Use: The Crosstrees PVA™ Pod is intended to provide surgeons with a percutaneous means to deliver bone cement to painful pathological compression fractures of the vertebral body by bilateral transpedicle or extrapedicle surgical approach in levels T4 – L5 of the thoracic and lumbar spine. Pathologic fractures of the vertebral body may be caused by osteoporosis. The Crosstrees Pod is intended to be used in combination with Fortibrae™ radiopaque bone cement when delivered by the Crosstrees CDrive™ fluid delivery device.


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