DFine Kyphoplasty

StabiliT® -Radio Frequency Kyphoplasty Procedure

StabiliT  from Dfine, is a new Kyphoplasty generation in vertebral compression fracture management.

The system provides a continuum of unique product attributes that offer physicians:

-  Unparalleled control:

  • Navigational, site and size specific cavity creation device 
  • Ultra high viscosity cement with extended working time
  • Controlled, constant rate cement delivery system 

-  Potentially increased safety for:

  • Patient: unipedicular approach – pass the cord once
  • Physician: reduced radiation exposure

-  Reduced expense:

  • Multi-level fracture kit – multiple levels at the price of one
  • Fully configured kit
  • Unipedicular approach saves physician/staff/facility time  

Patients will experience the following benefits after Dfine’s minimally invasive procedures:

  • Significant, immediate and lasting back pain relief
  • Significant improvement in mobility and quality of life
  • Return to daily activities soon after procedure
  • Procedures take 30-40 minutes under local anesthesia to complete
  • Small puncture to the skin typically covered with a band aid 
  • Patients can go home the same day or the following day depending on overall health of patient 

 

StabiliT from Dfine: A Combination of Unique Product Attributes

StabiliT was specifically designed to address current limitations in the treatment of vertebral compression fractures.

The procedure provides unipedicular access to the vertebral body using a 10 gauge access system. Site and size specific cavity creation through a single access point is achieved by using the MidLine Osteotome to navigate across the vertebral body creating individual channels.

Unipedicular vertebral body access

Minimizes bone destruction

Creates a site and size specific cavity

 

 

 

 

 

 

 

Site specific channels across the vertebral body allow for preferential flow and cement distribution across the fractured vertebra without indiscriminately creating large holes within the vertebra, thus sparing valuable cancellous bone.

SatabiliT creates an ultra high viscosity bone cement by heating specially formulated bone cement with RF energy. The combination of these product attributes results in delivery of the thickest bone cement on the market over an extended working time.

RF heated StabiliT® ER2 Bone Cement is more viscous than competitive bone cements. The increased viscosity over an extended period of time is important for two main reasons:

    1.     Provide the physician more control in where the cement is placed and consequently has the potential to reduce the risk of bone cement extravasation.

    2.     Improve the stability of the vertebra through increased controlled cement interdigitation and distribution across the vertebral body.

Ultra high viscosity StabliT® ER2 Bone Cement provides consistent interdigitation throughout the vertebra increasing the opportunity for endplate to endplate filling.

Potentially reduced physician radiation exposure, with the ability to stand 10 feet from the radiation source during the delivery of bone cement is another core feature to StabiliT. This allows remotely controlled cement delivery with a push of a button reducing physician exposure to radiation.