OsteoCool Acetabulum Image

Tumor Management

OsteoCool RF Ablation System

   Indications, Safety, and Warnings

OVERVIEW

The OsteoCool™ RF Ablation system is cooled radiofrequency (RF) ablation technology. It offers simultaneous, dual-probe capabilities for treating painful bone tumors.

INDICATIONS

  • 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

PRODUCT DETAILS

osteocool-dual-probe-monitor-image

KNOW WHERE THE HEAT IS GOING

OsteoCool RF Ablation delivers energy to the site consistently.

  • Algorithms designed to perform optimally in bone
  • Defined proximal and distal ablation boundaries
  • Predictable ablations
  • Confidence in ablation zone mapping

CUSTOMIZE YOUR ABLATION OPTIONS

  • Simultaneous ablation of adjacent or multiple levels in the spine
  • Simultaneous ablation using two probes, such as bipedicular spine tumor ablation
  • Ablation using one probe
  • 7mm, 10mm, 15mm, and 20mm active tip sizes
  • Multiple introducer gauge options
  • Track ablation

TREAT PAIN FOR BETTER DAYS

Bone is the third most common location where cancerous cells metastasize.1 The most common locations for bone metastases include the spine, pelvis, and hip.

Metastatic bone disease occurs in 60% to 80% of cancer patients, most frequently among patients with primary malignancies of the breast, prostate, liver, and lung.2

Bone metastases can affect quality of life, producing complications such as pain, fractures, and decreased mobility. In addition to these symptoms, they can cause mood changes such as depression and anxiety.3

Patients with metastatic bone cancer may be treated with conventional therapies such as opioids, chemotherapy, or radiation therapy for pain palliation. With OsteoCool RF Ablation, I can treat patients’ bone tumors when conventional therapies aren’t effective, are too slow acting, or cause unacceptable side effects.4

Dr. Sandeep Bagla Interventional Radiologist Vascular Institute of Virginia, Woodbridge, VA

DISCOVER HOW OSTEOCOOL WORKS

OsteoCool Dual Spinal Ablation

Coaxial, bipolar technology delivers RF energy to the site, and automatically moderates power to keep RF heating within the desired treatment range. This reduces risk of potential thermal damage to adjacent tissue.5

The active tip of the ablation probe is internally cooled with circulating water. RF energy heats the tissue while circulating water moderates the temperature close to the active tip. This combination:

  • Creates large volume lesions without excessive heating at the active tip
  • Minimizes potential for char

The OsteoCool RF ablation probes are sterile and intended for single use.

RISKS

  • 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™ bone access kits are indicated for percutaneous access to bone.*

1

Kurup AN, Callstrom MR, J Vasc Interv Radiol. 2010; 21(8 Suppl):S242-S250.

2

Schulman KL, Kohles J. Economic burden of metastatic bone disease in the U.S. Cancer. 2007; 109(11):2334-2342.

3

Goetz et al. Percutaneous Image-Guided Radiofrequency Ablation of Painful Metastases Involving Bone: A Multicenter Study. J Clin Oncol. 2004;22(2):300-306.

4

Gangi et al. Image-Guided Ablation Therapy of Bone Tumors. Elsevier Inc., 2009.

5

Based on internal testing. Data on file.

*

See OsteoCool Indications for Use.