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SIR: Kiva System Noninferior to Balloon Kyphoplasty

Posted on Wed, Apr 02, 2014
SIR: Kiva System Noninferior to Balloon Kyphoplasty

Novel implant system is noninferior for treatment of painful osteoporotic vertebral compression fractures

TUESDAY, March 25, 2014 (HealthDay News) -- The Kiva system, a novel implant for vertebral body augmentation, is non-inferior to balloon kyphoplasty for the treatment of vertebral compression fractures (VCFs), according to a study presented at the annual meeting of the Society of Interventional Radiology, held from March 22 to 27 in San Diego.

Sean M. Tutton, M.D., from the Medical College of Wisconsin in Milwaukee, and colleagues assessed the noninferiority of Kiva for vertebral body augmentation in the treatment of VCFs. Three hundred patients from multiple centers with one or two painful osteoporotic VCFs were randomized to receive the Kiva system (153 patients) or balloon kyphoplasty control (147 patients).

The researchers identified a 70.8 and 71.8 percent reduction in pain, as measured on the visual analog scale, and a 38.1 and 42.2 percent reduction in the Oswestry Disability Index, in the Kiva and balloon kyphoplasty groups, respectively. There were no device-related serious adverse effects. The primary end point of noninferiority of Kiva relative to balloon kyphoplasty was met, with a Bayesian Posterior Probability of 99.92 percent (P = 0.002), although there were significant differences in risk factors favoring the control group.

"This the first new method of treating these painful fractures in a decade, which is great news for patients because it not only helps restore quality of life, but it also was shown to outperform our most-used treatment in important ways," Tutton said in a statement.

Tutton disclosed financial ties to Benvenue Medical, the manufacturer of the Kiva system.

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