Procedure Overview

Vertebral augmentation utilizing Stryker’s iVAS Inflatable Vertebral Augmentation System is a refinement of vertebroplasty. During the procedure a balloon is inserted into the fractured vertebra and inflated, reducing the fracture. The balloon creates a void in the vertebral body, helping to allow for controlled and contained delivery of bone cement.^[11] The hardened bone cement creates an internal cast that helps to stabilize the fracture and can potentially reduce the kyphosis or exaggerated curvature of the spine, thereby alleviating pain in approximately 90% of patients.^{[11][12][13][14][15]}

Vertebral augmentation is performed through a small incision – typically less than three millimeters – in the patient’s skin. The procedure can be done on an outpatient basis and usually requires only a local anesthetic and mild sedation, eliminating possible complications that may result from open surgery. In some instances, general anesthesia is advised with a minimal hospital stay.^[16][17] Vertebral augmentation usually takes one hour to perform per fracture treated.

Using a sterile technique and fluoroscopic visualization, one or two high-pressure balloon catheters are advanced into the collapsed vertebra utilizing a transpedicular or bipedicular approach.^[11] The balloon(s) are then inflated, creating a central void and compacting the remaining trabeculae to the periphery.^[11] The balloon catheter(s) are then deflated and withdrawn, and specially formulated acrylic bone cement is injected into the void(s) created by the inflated balloon(s).^[11]Once set, the cement forms an internal cast that helps stabilize the bone, thereby decreasing or eliminating pain, increasing mobility, and improving quality of life.^{[11][12][13][14][15]}

Helpful Resources:
VCF Product Brochure (US) (3 MB, PDF)
Vertebral Augmentation Patient Brochure (669 KB, PDF)
iVAS Sell Sheet (264 KB, PDF)