FDA Clears Cardinal Health's Ava-Tex for Vertebroplasty

The FDA gave clearance to Cardinal Health's Ava-Tex Radiopaque Bone Cement for use by doctors to fix fractures of the spine, frequently the result of osteoporosis, or benign or malignant lesions.

The cement is commonly used by interventional radiologists in a minimally invasive procedure called vertebroplasty. Using imaging equipment to guide them, doctors insert a long needle through the back into the fractured vertebra, injecting the bone cement through the needle. The cement hardens inside the bones and fills gaps created by the fracture, strengthening collapsed vertebrae and relieving pain and pressure for the patient.

Ava-Tex Radiopaque Bone Cement is made from an acrylic resin called polymethyl methacrylate, or PMMA. Ava-Tex offers physicians an extended injection time once the cement is mixed and is designed for visibility with fluoroscopic imaging -- a specially designed mixing kit is included with the cement. The bone cement also has an extended injection time, giving physicians extra time during the procedure to safely inject the cement.