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Medical Devices / Regulatory Affairs / Submissions and Approvals

Benvenue Medical’s Kiva VCF Treatment System Gets 510(k) Nod

Jan. 30, 2014

Benvenue Medical has received 510(k) clearance from the FDA for its Kiva vertebral compression fractures treatment system, indicated for use in reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. The system offers the first new means of treating compression fractures in a decade, the company said Tuesday.

The Kiva implant, intended for use with the company’s Vertebral Augmentation Cement Kit, is made from Peek-Optima biocompatible polymer, providing mechanical support similar to natural bone, according to the Santa Clara, Calif., devicemaker. The delivery system inserts the implant 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 in the space inside the implant.

The amount of the Kiva implant delivered is physician-customized during the procedure, said company spokeswoman Betsy Merryman.

The company has already begun to roll out Kiva in the U.S. and expects to complete the launch by the second quarter. The device was CE-marked in 2008 and is distributed in Europe by Zimmer Spine. — Lena Freund

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