Patients
Indications for the use of
CERAMENT™|SPINE SUPPORT in adult patients
Non-weight bearing, stable osteoporotic compression vertebrae fracture
Spinal compression fractures due to osteoporosis often occur following a relatively minor trauma to the spine, such as opening a window or an insignificant fall. Severe cases of osteoporosis can even lead to a vertebral fracture from daily activities that would normally not cause a fracture, such as sneezing or coughing.
Treatment Options
Osteoporotic vertebrae compression fractures may not cause immediate symptoms, but other patients experience acute symptoms in the form of pain. Treatment can be non-surgical with pain medication, bed rest and back braces, or it can be surgical intervention in the form of minimal invasive Vertebroplasty or Kyphoplasty.
Vertebroplasty
The goal of performing vertebroplasty with CERAMENT™ is to reduce the pain caused by compressive fractures of the vertebrae and to accelerate the normal bone healing process. Vertebroplasty is typically performed by a trauma/orthopedic spine surgeon or an interventional radiologist. It is a minimally invasive procedure and patients usually go home the same or next day. During the procedure, CERAMENT™ is injected with a needle into the collapsed or fractured vertebra. The needle is placed with x-ray guidance. The injected, CERAMENT™ quickly hardens and forms a support structure within the vertebra, providing stabilization of the fracture, facilitating pain relief, bone remodeling and fracture healing.
CERAMENT™ can only be used for stable fractures in this indication.
Kyphoplasty
Kyphoplasty is a variation of a vertebroplasty that attempts to stop the pain caused by the fracture by creating a void prior to injecting CERAMENT™. The procedure includes inflation of a small balloon in the vertebral body prior to CERAMENT™ delivery. Once the void is created, the procedure continues in a similar manner as a vertebroplasty, by delivering Cerament directly into the newly created void. The injected CERAMENT™ provides stabilization of the fracture, pain relief, facilitate bone remodeling and fracture healing.
CERAMENT™ can only be used for stable fractures in this indication.
WARNING:
"Notice of availability”
“This product is NOT available for sales in the United States of America (USA)"
