McGAW PARK, Ill., June 9 - Cardinal Health, the leading provider of products and services supporting the health care industry, announced today it has received notice from the Food and Drug Administration (FDA) that its Ava-Tex® Radiopaque Bone Cement has been cleared for use by doctors to fix fractures of the spine. Spinal fractures are frequently the result of osteoporosis, 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.
Cardinal Health's Ava-Tex® Radiopaque Bone Cement is made from an acrylic resin called polymethylmethacrylate, or PMMA, the same material that was first used in hard contact lenses. The Ava-Tex cement offers physicians an extended injection time once the cement is mixed and is designed for visibility with fluoroscopic imaging. Included with the cement is a specially- designed mixing kit.
"This product is CE marked and has been on the market in Europe for three months," said Tom Daulton, vice president and general manager of Special Procedures at Cardinal Health. "Physicians have been asking for a cement designed to treat vertebral fractures, and we are very pleased to be able to offer this product, now that we have FDA clearance."
Dr. Avery Evans is one of the country's leading experts on vertebral fractures and has performed more than 2,000 vertebroplasties. He was among the first neuro-interventional radiologists in the country to perform the procedure.
"Cardinal Health's bone cement has an extended injection time, which gives physicians the extra time during the procedure needed to safely inject the cement," said Avery Evans, M.D., Associate Professor of Radiology, University of Virginia Health System. "It is also clearly visible when used with fluoroscopy which is paramount when performing the procedure."
About Cardinal Health
Cardinal Health, Inc. (www.cardinalhealth.com) is the leading provider of products and services supporting the health care industry. Cardinal Health develops, manufactures, packages and markets products for patient care; develops drug-delivery technologies; distributes pharmaceuticals and medical, surgical and laboratory supplies; and offers consulting and other services that improve quality and efficiency in health care. Headquartered in Dublin, Ohio, Cardinal Health employs more than 55,000 people on six continents and produces annual revenues of more than $65 billion.