Treatment Options

The traditional treatment for VCFs is conservative care with back braces, bed rest, and analgesic medications for alleviating pain. While the fracture eventually heals over time, the vertebral body remains in a collapsed, compressed state. Conservative care can result in prolonged pain, impaired function, and decreased activity. Additionally, bone and muscle loss resulting from a lack of activity can make recovery even more difficult, leading to the “downward spiral” of vertebral osteoporosis.(14)

In recent years, two minimally invasive VCF procedures have been introduced to treat VCFs. Vertebroplasty, developed in the early 1980s in France by Deramond and Galivert and introduced in the US in the mid 1990s, consists of injecting a thin bone cement into the vertebral body under high pressure.(18,19) The vertebral body is then stabilized by cementing the fractured bone in its existing position. The primary risk of vertebroplasty is cement extravasation, or leakage of bone cement into the surrounding space.(20)

Kyphoplasty, introduced in the late 1990s, was developed to treat VCFs. This procedure involves creating a cavity within the vertebral body by using an inflatable balloon tamp. The cavity is then filled with thicker bone cement under lower pressure in an effort to reduce the risk associated with cement leakage.(21)

While both of these procedures have been effective in reducing pain and stabilizing the fractured vertebral body, there are still clinical needs, which, if met, can improve the standard of patient care. Benvenue Medical has designed the Kiva VCF Treatment System* to address these unmet needs.

The Kiva VCF Treatment System is designed to:

  • Utilize a unilateral, transpedicular approach to access the vertebral body
  • Require less bone cement to stabilize the fracture than comparable procedures, thereby potentially reducing the incidence of cement extravasation

The Kiva VCF Treatment 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 Implant is delivered into the vertebral body with an all-in-one disposable device through a small diameter, single incision. The amount of the Kiva Implant delivered can be adjusted by the physician to accommodate various fracture types. The Kiva Implant is designed to function by providing a mechanical support structure, direct the flow and contain bone cement. 

 

United States — CAUTION — Investigational device. Limited by United States Federal Law to investigational use.