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Trial fully enrolled for evaluation of vertebral compression fractures treatment system

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Benvenue Medical Inc. has met the predetermined stopping rules for enrollment completion in the Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial. The trial will evaluate the company’s vertebral compression fracture treatment system.

According to a press release, the implant is designed to function as a mechanical support structure and a reservoir to contain and direct the flow of bone cement. The trial enrolled 300 patients and will compare the company’s implant with balloon kyphoplasty.

“We appreciate the efforts of the investigators and research coordinators, as well as the spine community’s enthusiasm to evaluate the potential benefits of the Kiva system. The results will be important to guiding treatment recommendations for vertebral compression fractures,” Steven R. Garfin, MD, professor and chairman of the department of orthopaedic surgery at the University of California, San Diego Medical Center, stated in the release.