Benvenue Completes Launch of Kiva VCF Spinal Fracture Treatment

Benvenue Medical says it has completed the full commercial launch of its Kiva VCF treatment system for vertebral compression fractures. The roll-out got underway in January, following the receipt of FDA 510(k) clearance.

“The launch is targeted at spine surgeons who treat spine fractures, which includes interventional radiologists/neuroradiologists, ortho- and neurosurgeons,” company spokeswoman Betsy Merryman said, adding Santa Clara, Calif., devicemaker is continuing to grow its direct sales forces and training team.

According to Benvenue, Kiva VCF presents the first new means of treating compression fractures in 10 years and demonstrates equal or superior safety and efficacy, adjacent level fracture rate, Kyphotic Angle restoration and cement volume and extravasation rate when compared with Medtronic’s balloon kyphoplasty system. The device was evaluated in one safety and effectiveness trial and three comparative studies, comprising more than 500 patients, the company said.

The Kiva cylindrical implant is used with the company’s Vertebral Augmentation Cement Kit and is made from Peek-Optima biocompatible polymer, whose mechanical support resembles that of natural bone, Benvenue said. The device is implanted percutaneously into the affected vertebra over a removable guidewire in a continuous loop that acts as a containment mechanism. Once the implant is in place, cement fills the cylinder.

Kiva VCF is indicated for use in reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is CE-marked in Europe and distributed there by Zimmer. — Lena Freund

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