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Benvenue Medical receives 510(k) clearance for spinal fracture treatment

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The FDA issued 510(k) clearance to Benvenue Medical Inc. for its Kiva VCF Treatment System for the reduction and treatment of spinal fractures.

According to a company press release, the Kiva System is a novel implant-based solution for vertebral augmentation and a departure from balloon kyphoplasty, making it the first new approach to the treatment of vertebral compression fractures (VCF) in more than a decade.

“We are excited to bring the Kiva System and its clinical benefits to the large and growing population of VCF patients in the U.S. market,” Robert K. Weigle, chief executive officer of Benvenue Medical, stated in the release. “The VCF segment has little level I clinical data, and we are proud to have sponsored one of the largest randomized studies in this space to date.”