Medgadget tipster Fabio P. has alerted us to an interesting new product on the market for the treatment of vertebral compression fractures caused by osteoporosis, cancer, and trauma. StaXx® FX Structural Kyphoplasty System, a minimally invasive system from Spine Wave, Inc. (Shelton, CT), has just been approved by the FDA. The device works via a proprietary design of innovative PEEK wafers “which are stacked in situ to simultaneously distract and support the fractured vertebral body. The minimally invasive system is designed to provide pain relief and a controlled vertical fracture reduction.”
Here’s how the company presents its product:
The StaXx® Structural Kyphoplasty System is a minimally invasive system designed to treat vertebral compression fractures caused by osteoporosis, cancer, and trauma offering surgeons an innovative alternative to vertebroplasty and traditional kyphoplasty.
With a unilateral extrapedicular approach, the StaXx® FX Structural Kyphoplasty System is a vertebral compression fracture repair system that is designed to provide controlled fracture reduction in precise 1mm increments. The StaXx® FX System is designed to maintain vertebral body height restoration with a permanent structural PEEK implant.
Attributes of the StaXx® Structural Kyphoplasty System:
No Intra-operative reduction loss Controlled vertical expansion in 1mm increments Barrier to posterior extravasation Reduced bone cement volume
Potential patient benefits of achieving fracture stabilization and correction of spinal deformity may include significantly reduced pain, restored natural spine biomechanics, and improved quality of life.
To see the system, go to the product page…
Press release: Spine Wave Receives FDA Clearance for the StaXx® FX Structural Kyphoplasty System (.pdf) …