CareFusion obtains two FDA clearances for spine augmentation devices

CareFusion, a BD company (NYSE: BDX), today announced the U.S. Food and Drug Administration (FDA) has cleared two 510(k)s for its spine augmentation devices.

The new 13-gauge AVAmax^® Vertebral Balloon system expands the company's offerings in devices to treat vertebral compression fractures. The balloon fits down a 13-gauge cannula, which has a cross-sectional area that is 37 percent smaller than the 11-gauge cannula and 50 percent smaller than the 10-gauge cannula. The smaller size creates a smaller access point, resulting in less trauma than larger cannulas. This will be the smallest straight-line vertebral balloon in the industry to date, enabling vertebral augmentation higher in the spine than with current offerings. The 13-gauge balloon will be offered in 10mm, 15mm and 20mm lengths.

The new 11-gauge AVAflex^® Vertebral Balloon System will enable targeted balloon placement across the midline of the vertebral body through a unipedicular, lateral approach, but higher in the spine through a smaller cannula than current products. The AVAflex needle then allows targeted cement placement for an optimal fill. Once commercially available, the 11-gauge AVAflex balloon will be the smallest curved balloon in the industry and will also have the benefits of a smaller access point and less trauma to the patient. The 11-gauge AVAflex will be available in 15mm, 20mm and 30mm lengths.

"We are committed to investing in research and development to create new innovations that benefit patients and providers," said Jim Leitl, worldwide vice president and general manager of Infection Prevention, V. Mueller and Interventional Specialties for BD. "We are proud to offer a wide variety of minimally invasive vertebral augmentation devices for providers to choose the right treatment for their patients."

CareFusion expects a full commercial launch within a year. With this launch, CareFusion will maintain the most comprehensive portfolio of vertebral balloon products in the industry.