OsteoCool RF ABLATION SYSTEM

Count on OsteoCool for reproducible precision

The OsteoCool™ RF Ablation system offers cooled radiofrequency (RF) ablation technology with simultaneous, dual-probe capabilities – providing procedural flexibility and predictable, customized treatment. Cooled RF ablation uses targeted heat energy to destroy cancer cells.

The OsteoCool Bone Access Kits provide the capability to map the ablation zone based on tool placement. Additionally, the OsteoCool RF Ablation data demonstrates reproducible lesions giving confidence in the ablation zone outcome.*

  • Defined anterior and posterior ablation boundaries
  • Predictability
  • Confidence in ablation zone mapping

*Based on internal bench testing. Data on file.

Treating pain for better days

Metastatic Bone Disease has been reported to occur in 60-80% of cancer patients,1 most frequently amongst patients with primary malignancies of the breast, prostate, liver and lung.

The most frequent complaint of patients with skeletal metastases is the pain associated with the disease,1 occurring in 79% of patients.3 The pain is usually progressive and significantly reduces quality of life.4 Metastatic lesions in the spine become painful due to neural compression, pathologic fracture or other biochemical mechanisms.5

The most common complaint associated with spine metastases is pain—it's often progressive and significantly reduces the patient's quality of life. With the OsteoCool system, I can now ablate the patient's painful tumor with a reproducible procedure that’s appropriate for their unique anatomy.

Sandeep Bagla, MD
Interventional Radiologist with the Vascular Institute of Virginia in Woodbridge, VA

How the OsteoCool System works

The OsteoCool™ RF Ablation System6 is intended for:

  • Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body
  • Coagulation and ablation of tissue in bone during surgical procedures, including palliation of pain associated with metastatic lesions involving bone — in patients who have failed or are not candidates for standard therapy

Risks of the OsteoCool™ RF Ablation System:

  • As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury could occur
  • Pulmonary embolism
  • Nerve injury including thermal injury, puncture of the spinal cord or nerve roots potentially results in radiculopathy, paresis, and paralysis

The OsteoCool RF Ablation Probe uses a coaxial, bipolar technology that delivers localized tumor ablation and automatically moderates power to keep RF heating within the desired treatment range, reducing risks of potential thermal damage to adjacent tissue.

The active tip of the RF Ablation Probe is internally-cooled with circulating water. RF energy heats the tissue while circulating water moderates the temperature in close proximity to the active tip. This combination creates large volume lesions without excessive heating at the active tip.

The OsteoCool RF Ablation Probes are sterile and intended for use within a single vertebral body.

Watch the animation to see the OsteoCool System in action.

The OsteoCool System gives you procedural flexibility

With the option to use two OsteoCool RF ablation probes simultaneously, the OsteoCool RF Ablation system can support a variety of ablation scenarios to accommodate patient and procedural necessity.

  • Simultaneous treatment of adjacent or multiple levels
  • Simultaneous bi-pedicular ablation
  • Uni-pedicular ablation
  • 7mm, 10mm and 20mm active tip sizes
  • Multiple introducer gauge options

Where indicated, bone access can be used for a subsequent physician-directed procedure such as cementoplasty (i.e. vertebroplasty or Kyphoplasty®). See Indications for Use.

EDUCATION
AND TRAINING

Physician education and training events for the OsteoCool™ RF Ablation procedure and the use of OsteoCool™ Bone Access Tools are offered throughout the year at various locations. Please contact your local Medtronic sales representative for more information.

CODING AND REIMBURSEMENT ASSISTANCE

Medtronic SpineLine® is the best source for questions regarding procedural coding. Call 877-690-5353

LEARN MORE ABOUT OSTEOCOOL™

Get help from if you have questions or need technical assistance.

Contact your Medtronic sales rep for more information about the OsteoCool™ RF Ablation System. Don't have a rep? Contact customer service at 800-933-2635.

Cementoplasty (i.e. kyphoplasty or vertebroplasty): Indications for Use

Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

Kyphon® HV-R® Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a kyphoplasty or vertebroplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor.

The complication rate with Kyphon® Balloon Kyphoplasty has been demonstrated to be low. There are risks associated with the procedure (e.g., cement extravasation), including serious complications, and though rare, some of which may be fatal. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices' Instructions for Use included with the product.

References

  1. Schuleman et al. Economic Burden of Metastatic Bone Disease). American Cancer Society 2007.
  2. Kurup, A. Nicholas and Callstrom, Matthew R. Ablation of Skeletal Metstases: Current Status. J Vasc Interv Radiol 2010; 21:S242-S250
  3. Jan Jan et al. Therapeutic Guidelines for treatment of bone metastases. Journal of Palliative Medicine, 2009.
  4. Nakatsuka, Yamakado et al. 2004.
  5. Wallace et al. Radiofrequency ablation and vertebral augmentation for palliation of painful spinal metastases. J Neurooncol May 2015.
  6. OsteoCool Indications for Use. Consult instructions for use at this website http://www.medtronic.com/manuals.

Indications, Safety, and Warnings