CareFusion Corp., a medical technology company based in San Diego, has launched the AVAmax Vertebral Balloon, a device designed to improve and reduce the costs of kyphoplasty, a treatment for spinal compression fractures.

“We are a relatively new medical device company, but we are no novice,” said Jim Mazzola, senior vice president of communications. “We were formed by a spinoff of Cardinal Health. Many of our products have been in the marketplace and been market leaders for years. We have about 2,200 employees in San Diego, all aligned with a vision to improve the safety and cost of health care.”

The release of the product marks a competitive breakthrough that likely will reduce the cost of treating spinal fractures, he said. The vertebral balloon and its components will cost as much as 40 percent less than similar kyphoplasty products on the market, improving accessibility.

The global kyphoplasty procedure health care market represents approximately $600 million in sales. To introduce its new product, CareFusion has created a dedicated sales force in the U.S. and plans to expand availability to Europe.

During a kyphoplasty, a small balloon is used to create a cavity in the vertebral body. Bone cement is then delivered into the cavity to stabilize the fracture. Vertebroplasty, a similar procedure, does not use surgical balloons before injecting the cement.

According to CareFusion, compression fractures often are caused by osteoporosis, a disease that affects an estimated 10 million Americans. Such fractures may result in severe pain, a reduction in height, and difficulty with balance. An estimated 50 percent of women and 25 percent of men over the age of 50 in the U.S. will experience an osteoporosis fracture.  

Physicians Test Product

Mazzola said the AVAmax Vertebral Balloon can reduce costs whether used by hospitals or within a physician’s practice. During a limited release of the product, CareFusion completed approximately 300 case studies in which eight out of 10 physicians said they would strongly consider switching to the AVAmax product.

The product is part of a system that includes an eight-gauge or 10-gauge needle, bone cement and delivery instruments for kyphoplasty or vertebroplasty. The AVAmax PLUS vertebral augmentation system, which delivers cement for the procedure, allows radiologists to keep their hands outside of the radiation field, minimizing exposure.

John K.B. Afshar, a neurosurgeon at The Center for Cranial & Spinal Surgery in Stuart, Fla., said he has performed at least 10 surgeries using the new CareFusion device. When performing kyphoplasty, “we try to pop the fracture back (into place) if we can and also to compact the bone so that when we deliver the cement the leakage rate is a lot less.”

The AVAmax Vertebral Balloon isn’t the only such device on the market, but it is less invasive and “considerably cheaper,” he said. That means it offers a greater potential for being used by patients as health care providers work to tighten their budgets.

CareFusion develops a variety of technologies. They include automated dispensing and patient identification systems, ventilators, respiratory products, skin-prep products and services for infection surveillance. The company employs more than 15,000 people worldwide and about 2,200 in the San Diego region.

“We manufacture products that primarily are used in hospitals and even within critical-care settings,” Mazzola said. “We make technologies that are used in hospitals worldwide. Our primary business outside the U.S. is in Europe, Western Europe in particular.”

Potential to Reduce Treatment Errors

Nancy G. Pratt, senior vice president of clinical effectiveness at Sharp HealthCare, said CareFusion creates products that help reduce the potential for human error.

“We use a lot of products from CareFusion,” Pratt said. “They have been long-standing partners with Sharp HealthCare. They are a very large presence in the industry across the country. From a patient safety perspective, this kind of technology is critical. What we want is the technology to help prevent us from making mistakes. CareFusion has a bar coding where you can check the patient’s identification band before you give a medication, before you draw a lab specimen or before you administer blood. Those technologies are very useful in helping drive patient safety success.”

Emmet Pierce is a freelance writer for the San Diego Business Journal.