Benvenue Medical, Kiva, Blazer and Luna 3D are registered trademarks of Benvenue Medical Inc.
KIVA VCF Treatment System:
Kiva Vertebral Compression Fracture System is available for sale in the United States and Europe.
United States: 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 Vertebral Augmentation Cement Kit.
Europe: The Kiva VCF Treatment System is indicated for the reduction and treatment of pathological compression fractures of the thoracic and lumbar spine that may result from osteoporosis, benign lesions and/or malignant lesions. This is to be offered only when traditional medical therapy has not provided pain relief and pain is substantially altering the patient’s lifestyle. It is intended to be used with Benvenue Medical Vertebral Augmentation Cement Kit. Kiva VCF Treatment System bears the CE mark and is available for sale in Europe.
BLAZER-C Vertebral Augmentation System:
Blazer–C Vertebral Augmentation System is available for sale in the United States.
Blazer–C – United States: Blazer–C is indicated for the treatment of pathological compression fractures of the vertebral body that result from osteoporosis, benign lesions, or malignant lesions, by creating channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA).
As with other vertebral augmentation devices and procedures, there are risks and considerations for use of the products listed on this site. The risks include serious complications up to and including death. Please see product labeling for more detailed discussion of risks, contraindications, warnings, and precautions. – See more at: http://benvenuemedical.com/legal/#sthash.PxUiuR6w.dpuf
LUNA 3D Interbody Fusion System:
Luna 3D Interbody System is available for sale in the United States.
The Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D Interbody Fusion System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D Implant. The Luna 3D Interbody Fusion System is to be used with supplemental fixation.
As with other lumbar fusion devices and procedures, there are risks and considerations for use of the Luna 3D Interbody Fusion System. Please see the product labeling for a detailed discussion of risks, contraindications, warnings and precautions. Failure to follow any instructions or failure to heed any warnings or cautions could result in serious patient injury.