The FDA has approved the PVA Pod System for percutaneous vertebral augmentation (PVA). The device is made by Crosstrees Medical, a Boulder, Colorado based medical device company. PVA is a minimally invasive procedure to augment a vertebra that has fractured due to vertebral compression fracture. A vertebral compression fracture occurs when osteoporosis, trauma, or any other medical condition causes the vertebra to become fragile and collapse, causing severe pain. Vertebral compression fractures can lead to loss of height, postural deformity and pulmonary complications. An estimated 700,000 people in the United States have vertebral compression fractures annually, according to the National Osteoporosis Foundation.
The PVA Pod System is designed to control delivery of bone cement and decrease the risk of bone cement leakage associated with vertebroplasty and kyphoplasty, the current standards of care for vertebral compression fractures. The Crosstrees Pod System uses a polymer fabric Pod that allows the surgeon to control the flow of bone cement as it is introduced into the vertebral body. During the procedure, the physician will insert the Crosstrees Pod into the fractured vertebra through a very small skin incision. The Pod will be filled with liquid bone cement and then opened and removed so that only the cement remains in the treated bone of the spine. The Crosstrees procedure can be performed under local or general anesthesia. Overnight stay in the hospital may not be required after the procedure, the recovery time is short and most patients are ready to walk within hours.
Product page: Crosstrees Pod System for PVA
Press release: Crosstrees Medical Receives FDA 510(k) Clearance for Next Generation Device for Percutaneous Vertebral Augmentation (PVA)