Authors' objectives: Vertebral compression fractures (VCFs) occur when pressure is placed on weak vertebrae. More than 700,000 VCFs are diagnosed in the United States every year, causing substantial morbidity due to symptoms such as severe pain and disability in some patients. A majority (85%) of VCFs are due to osteoporosis; the remainder are due to primary or metastatic malignancy, hemangioma, or vertebral osteonecrosis. Description of Technology: The Kiva system is a vertebral augmentation device that includes a cylindrical coil implant that is placed in the vertebrae and then filled with polymethyl methacrylate bone cement. Together, the implant and cement are intended to stabilize the VCF and relieve pain. Patient Population: The Kiva VCF Treatment System is intended for patients who have spinal fractures in the thoracic or lumbar spine, from T6-L5, and related symptoms for which conservative treatments have failed. Clinical Alternatives: Percutaneous balloon kyphoplasty is a related minimally invasive procedure in which an inflatable bone tamp is used to elevate the fracture prior to cement injection. It differs because the balloon is not an implant and is removed prior to cement injection. Percutaneous vertebroplasty is also related and differs from kyphoplasty and augmentation because no device is used prior to cement placement.

Project Status: Completed

Year Published: 2016

URL for published report: The report may be purchased from: http://www.hayesinc.com/hayes/crd/?crd=56526

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: HAYES, Inc.

Contact Address: 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218

Contact Name: saleinfo@hayesinc.com

Contact Email: saleinfo@hayesinc.com

Copyright: Winifred S. Hayes, Inc