The Kiva® VCF Treatment System provides a new implant-based approach to vertebral augmentation in the treatment of painful VCFs. 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 Benvenue Medical Vertebral Augmentation Cement Kit.
The Kiva System features a proprietary flexible implant made from PEEK-OPTIMA®, a biocompatible polymer that is widely used and well accepted as a spinal implant. The Kiva implant is designed to provide structural support to the vertebral body and a reservoir to direct and contain bone cement during vertebral augmentation. The implant is delivered percutaneously over a removable guidewire in a continuous, spiral loop into the vertebral body through a small diameter, single incision. The amount of the Kiva implant delivered is physician-customized during the procedure.
Kiva is a unipedicular, PEEK-OPTIMA implant, solution for vertebral augmentation and a departure from balloon kyphoplasty making it the first new approach to the treatment of vertebral compression fractures in over a decade. Kiva has been demonstrated to meet or exceed the performance of balloon kyphoplasty (BKP) in three separate comparative studies(24,25,26). In one or more of these studies, as compared to BKP, Kiva was shown to:
- Reduce rate of adjacent level fracture
- Improve kyphotic angle restoration
- Reduce rate of cement extravasation
- Reduce the cement volume
The Kiva VCF System features a deployment device that allows the treating physician to seamlessly deliver the implant to the patient through one small incision. Unlike with balloon kyphoplasty systems, this device does not require a bi-pedicular approach and it does not require the treating physician to deflate a balloon in order to fill the vertebral body with cement. In clinical studies, the Kiva System was shown to meet or exceed the performance of balloon kyphoplasty in subsequent fracture rates, cement extravasation (leakage) rates and pain/function scores.
Cylindrical Implant Design
- Stabilizes fracture with less amount of bone cement
- Implant design acts as cement restrictor
- Implant directs cement flow centrally
- Physician customizes the amount of implant delivered into fracture
PEEK-OPTIMA Implant Material
- More similar to cortical bone than PMMA
- Even with PMMA, 50% less stiff than PMMA alone
Nitinol Kiva Coil
- Pre-shaped Nitinol wire retains its stacked coil configuration
- Creates a track within the cancellous bone for implant deployment
- Radiopaque and highly visible under fluoro
MIS, Unilateral Approach
- Kiva is delivered through a transpedicular approach
The Kiva VCF Treatment System 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 Benvenue Medical Vertebral Augmentation Cement Kit.
As with other vertebral augmentation devices and procedures, there are risks and considerations for use of the Kiva VCF Treatment System. The risks include serious complications up to and including death. Please see the product labeling for a more detailed discussion of risks, contraindications, warnings and precautions. Consult a healthcare provider regarding specific treatment options.