CareFusion Announces National Launch Of Spinal Fracture Device

Main Category: Bones / Orthopedics
Also Included In: Medical Devices / Diagnostics;  Radiology / Nuclear Medicine
Article Date: 28 Aug 2010 - 2:00 PDT

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CareFusion (NYSE: CFN), a leading, global medical device company, announced the national commercial launch of the AVAmax® Vertebral Balloon, a minimally invasive device for use during kyphoplasty, a procedure for treating spinal compression fractures.

The AVAmax Vertebral Balloon represents a competitive breakthrough and is expected to enhance the affordability of spinal fracture procedures. CareFusion's vertebral balloon product and related components cost up to 40 percent less than similar kyphoplasty products on the market today, making the procedure more cost effective and accessible to hospitals and outpatient surgery centers.

During the product's limited release period, CareFusion completed approximately 300 case studies with eight in 10 physicians saying they would strongly consider switching to the AVAmax product, according to post-product evaluation surveys.

The AVAmax Vertebral Balloon is part of an all-in-one system that includes an eight-gauge or 10-gauge needle, bone cement and delivery instruments for kyphoplasty or vertebroplasty, an alternate procedure to treat compression fractures. The all-in-one system gives doctors the choice and flexibility to perform either procedure at the time of patient care.

"The AVAmax Vertebral Balloon is easier to use and more efficiently designed than the system previously available to me," said C. Douglas Edmondson, M.D., FACR, Interventional Radiologist at Medical Center of South Arkansas. "With one more tool in the AVAmax toolbox, I can more selectively tailor spinal interventions with vertebropasty or kyphoplasty with a huge cost savings and no wasted materials."

The AVAmax® PLUS vertebral augmentation system, which delivers cement for the procedure, allows the radiologist's hands to be out of the radiation field leading to reduced radiation exposure by clinicians.

CareFusion has established a dedicated sales force to sell the AVAmax Vertebral Balloon in order to drive product adoption and market penetration in the U.S. The company intends to expand commercial availability to Europe. The global kyphoplasty procedure health care segment is currently estimated to represent approximately $600 million in sales.

With the launch of the new AVAmax Vertebral Balloon, CareFusion now offers a full line of products in one system that address both vertebroplasty and balloon kyphoplasty, the two primary approaches to treat spinal compression fractures by delivering bone cement into the vertebral space with specialized needles. CareFusion is already a market leader in devices for vertebroplasty procedures.

More about kyphoplasty

Spinal compression fractures are often caused by osteoporosis, a disease of low bone strength that affects an estimated 10 million Americans, resulting in an estimated 700,000 spinal fracture cases that can cause disabling pain, height loss, balance difficulties and a decreased quality of life. In the U.S., approximately 50 percent of women and 25 percent of men over the age of 50 will experience an osteoporosis fracture in their lifetime.

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 spinal fracture. A vertebroplasty does not include the use of a surgical balloon to create a cavity before delivering the cement.

Source: CareFusion Corporation

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