Crosstrees Medical Receives FDA 510(k) Clearance for Next Generation Device for Percutaneous Vertebral Augmentation (PVA)
Officials from Crosstrees Medical Inc. announced that the company received 510(k) clearance from the US Food and Drug Administration (FDA) for the Crosstrees PVA Pod System for Percutaneous Vertebral Augmentation (PVA). FDA clearance was based on a prospective, single-arm IDE study that enrolled 135 patients in the United States, China, Venezuela, and Belgium. Patient outcomes for the Crosstrees procedure were compared to a literature control, which included vertebroplasty and kyphoplasty outcomes. The IDE study met its primary endpoints of a significant reduction in pain scores and PMMA bone cement extravasation over a follow-up period of 12 months. Additionally, the Crosstrees procedure demonstrated a significant reduction in new fracture rates often found with vertebroplasty and kyphoplasty procedures.
The Crosstrees Pod technology was designed to address the need for improved vertebral fracture repair devices by taking a novel approach to controlling the delivery of PMMA to the site of fracture and subsequently reducing the risk of complications caused by PMMA leakage, such as nerve root compression, pulmonary embolism, and additional adverse events as reported in the published literature. Additionally, the Crosstrees Pod technology’s novel approach to percutaneous vertebral augmentation has been shown to reduce new vertebral fractures significantly during post treatment where literature reported rates range from 23% to 48%. Devices using the Crosstrees Pod technology feature a polymer material to control the delivery of a specific volume and geometry of PMMA bone cement to the vertebral fracture site. Following PMMA delivery, the construct is opened and removed from the vertebra, leaving only the PMMA filler material behind. The Crosstrees procedure involves steps familiar to physicians currently doing percutaneous vertebral augmentation and does not require an implanted device in the spine.
“Crosstrees PVA Pod System is now FDA-cleared and CE-marked, making a promising new treatment option available to patients with vertebral compression fractures,” states Robert Scribner, president & CEO of Crosstrees Medical Inc. “We very much appreciate the efforts of our investigators and their research staffs in the successful completion of the IDE clinical study and FDA review process. 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.”
“In my experience with the Crosstrees Pod System, the technology presents an important opportunity to improve PVA procedures,” says Philip S. Yuan M.D., of the Memorial Orthopaedic Surgical Group in Long Beach, CA. “The surgical procedure offers unprecedented PMMA control which may reduce leakage complications, and the 12-month IDE study outcomes clearly demonstrate superior pain relief and reduced new fracture rates in patients with osteoporotic compression fractures.”
Estimates for the incidence of pathologic vertebral compression fractures in the USA by the National Osteoporosis Foundation exceed 700,000 annually.
About Crosstrees PVA Pod System
The Crosstrees PVA Pod System is now approved for marketing in the U.S. and in Europe, where it has CE mark approval. This approval is based on the data from a prospective, single-arm investigational device exemption (IDE) study in which 135 individuals with vertebral compression fractures were enrolled. Study participants were followed for 12 months and assessed for pain relief, bone cement leakage, rates of new fractures, and additional outcome measures. The Crosstrees Pod 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. This use of a fabric pod eliminates the balloon inflation step required in traditional kyphoplasty procedures. The Crosstrees Pod system reduces the need for repeated device exchanges during the procedure. The system design simplifies the procedure and potentially reduces procedure time.