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Products / Spine Solutions / Kiva® VCF Treatment System

 

Kiva® VCF Treatment System

A Novel Treatment For Vertebral Compression Fractures

If you’re searching for a different treatment for vertebral compression fractures, be sure to take a look at the KIVA® VCF Treatment System.

Kiva has met or exceeded the performance of balloon kyphoplasty in 3 separate comparative studies. In one or more of these studies, Kiva was shown to:

  • Reduce rate of adjacent level fracture

  • Improve kyphotic angle restoration

  • Reduce rate of cement extravasation

  • Reduce cement volume

The KIVA System is the first new approach to treating vertebral compression fractures (VCF’s) in over a decade. For the first time, physicians can deliver (through a transpedicular approach) an implant with a predictable structure. The implant also serves as a reservoir to contain and direct the flow of cement. It is indicated for use in the reduction and treatment of spinal fractures in the Thoracic and/or lumbar spine from T6-L5*. It is intended to be used in combination with the IZI Vertebral Augmentation Cement Kit.

 
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How Does Kiva Work?

Kiva is a Unipedicular System. The Kiva Implant is delivered percutaneously over a removable guide-wire in a continuous loop into the vertebral body through a small diameter, single incision. Physicians can customize the amount of the implant delivered during the procedure to adjust to vertebral compression fracture morphologies. With Kiva, bone cement is delivered simultaneously through both the access cannula and the implant. This eliminates the added steps required by other systems.

Biomechanical & Biomedical Advantages of the Kiva Implant

A bench test material comparison demonstrated that theKiva Implant is 63% less rigid than PMMA bone cement alone, which may reduce the risk of adjacent level fractures.1,2,3

(Compression testing at same rate to identical peak load (.5Hz, 300-3000N))

Clinical Studies & Key Findings

KAST: The Kiva® System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial.

Design: 
Prospective, randomized clinical trial to evaluatethe safety and effectiveness, and support non-inferiorityof the Kiva VCF Treatment System versus balloon balloon kyphoplasty: 300 patient trial

Authors/Publication: 
Tutton, Garfin, et al. Spine, June 2015.

Key Findings

Kiva Compared to BKP:

  • Similar pain reduction and function improvement

  • Reduced rate of adjacent level fractures - per protocol population

  • 50% less cement volume used

  • Significantly reduced rate of extravasation as reported by investigators

Balloon kyphoplasty versus KIVA Vertebral Augmentation. Comparison of two Techniques for Osteoporotic Vertebral Body Fractures. A prospective randomized study.

Design: 
Prospective, randomized study: 168 patients treated

Authors/Publication: 
Korovessis, et al. Spine, February 2013.

Key Findings

Kiva Compared to BKP:

  • Similar pain reduction, function and QOL improvement

  • Significantly reduced kyphosis (i.e. restoration of

    Gardner angle)

  • Lower extravasation rates

  • Lower cement volume used

Comparison of balloon kyphoplasty with the new KivaVCF System for the treatment of vertebral compression fractures.

Design:
Matched pairs study of Kiva vs. balloon kyphoplasty with Medtronic balloons: 52 patients

Authors/Publication:
Otten, Pflugmacher, et al. PainPhysician Journal, October 2013.

Key Findings

Kiva Compared to BKP:

  • Significantly fewer new fractures after treatment

  • Mean cement used was less than half with Kiva

  • Significantly greater pain reduction at 6 months

The Implant Solution for the Restoration of Sagittal Alignment

Structural Support

  • Expandable implant preserves natural bone structure

  • Predictable structure restores spinal alignment1

  • Controlled bone cement footprint for permanent spine restoration2

Predictable, Published Results

  • Improved kyphotic angle restoration vs. BKP1

  • Reduced rate of adjacent level fractures vs. BKP2

  • Proven economic savings vs. BKP4

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PRODUCT DETAILS

Interested in the Kiva® VCF Treatment System?

Learn more about how the system and accessories are packaged, access surgeon & patient brochures, and download over a dozen clinical articles on Kiva®.

*Note: Parts and configurations are subject to change based on regulatory jurisdiction. Please consult with your Account Representative for details.