The Osseoflex® SB family of steerable inflatable bone tamps are steerable, articulating balloons for vertebral augmentation. The Osseoflex SB enables access to the entire vertebral body with unprecedented navigation and precision. Osseoflex SB steerable balloons are available in 10 gauge, 2ml and 4ml balloon sizes, for the treatment of vertebral compression fractures.
Utilizing either a unipedicular or bipedicular approach, the Osseoflex SB steerable balloon creates a cavity by compacting cancellous bone, to allow bone cement to be delivered directly to the pathology. If used unipedicular, the single point access reduces procedure time and decreases risk to the patient.
Osseoflex SB Description
The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA bone cement is injected through an Osseoflex® needle to fill the previously created void(s).
An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existing channel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.
Osseoflex SB Indications for Use
The Osseoflex® SB is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.