HCP in scrubs.

About OsteoCool RF Ablation for Proceduralists

   Indications, Safety, and Warnings

KNOW THE FACTS

Medtronic offers radiofrequency ablation to help treat painful bone tumors. Patients with metastatic bone cancer may be treated with conventional therapies such as opioids, chemotherapy, or radiation therapy for pain palliation. With OsteoCoolTM RF Ablation, physicians can address pain associated with metastatic bone tumors when conventional therapies aren’t effective, are too slow acting, or cause unacceptable side effects.1

Bone icon image.
Bone is invaded in 60-80% of patients with metastatic disease,2 most frequently among patients with primary malignancies of the breast, prostate, and lung.3
Spine icon image.
More than 80% of bone metastases are found in the axial skeleton, and the spine, pelvis, and ribs are often the earliest sites of disease.4
Patient in hospital bed icon image.
Bone metastases can impact patients’ quality of life, producing complications such as pain, fractures, and decreased mobility.5 In addition to these symptoms, pain from metastases can cause mood changes such as depression and anxiety.6

Procedure Goals

Clinical Evidence for RFA + AUGMENTATION VERSUS AUGMENTATION ALONE FOR SPINAL METASTASES

Retrospective study shows patients treated with a combination of radiofrequency ablation and vertebral augmentation experienced significant pain relief.
 
Metastatic lesions of the spine may become painful due to neurological compression, pathologic fracture, or other biochemical mechanisms.7   While some pain derives from biological sources such as cytokine release, other pain sources are mechanical such as tumor periosteal pressure and tumor impingement on neural structures.8
The goal of bone tumor RFA is to eradicate these sources of pain, independent of the mechanical stabilization need. 
 
Medtronic’s RF ablation device, the OsteoCool RF Ablation System, is coaxial, bipolar technology that uses algorithms designed to perform optimally in bone. With the OsteoMapSM Technique, you can be confident in your anterior and posterior margins to ensure you are covering the entire tumor.  Where indicated, you can use the same OsteoCool bone access for subsequent procedures such as cementoplasty (e.g., kyphoplasty, sacroplasty, or vertebroplasty) to stabilize the fracture.
 
 
Download the combined OsteoCool + Kyphoplasty Brochure

Case review

METASTATIC DISEASE CASE STUDY USING OSTEOCOOL

Dr. Levy portrait.
“This particular case became a learning experience for me to reach out to our local radiation oncologists to talk about who should be treated first when it comes to patients at risk for future fracture. We have the same goals and obligations to provide the best care for these patients. We know we need to address these patients’ pain quickly, stabilize fractures and get ahead of delayed skeletal events especially in axial loading areas with lytic metastases. With the addition of OsteoCool, treatment options for these patients have expanded. When I have completed the ablation, I can stabilize with kyphoplasty or vertebroplasty right away where indicated. I do this using the same access channel.” – Jason Levy, MD, Northside Hospital, Atlanta, GA

 

Dr. Levy case review image.
PATIENT HISTORY
 
  • 42-year-old female
  • Breast Sarcoma
  • Pain Score 10/10
  • Multifraction EBRT completed one week prior to consult
  • Unable to ambulate and off systemic therapy protocol
Dr. Levy case review image.
IMAGES PRIOR TO ABLATION
 
  • T5 fracture
  • No neuropathy

 

Dr. Levy case review image.
ABLATION
 
  • T5 ablation

 

 

Dr. Levy case review image.
RESULT SUMMARY/UPDATE
 
  • Pain score after 4/10 next morning
  • Up and out of bed doing PT
  • Back on systemic therapy
HEAR HOW YOUR PEERS ARE USING OSTEOCOOL

IMPORTANT SAFETY INFORMATION

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
  • Ablation of benign bone tumors such as osteoid osteoma

RISKS

  • As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury could occur
  • Pulmonary embolism
1

Sabharwal et al. Image-Guided Ablation Therapy of Bone Tumors. Semin Ultrasound CT MRI. 2009;(2):78-90.

2
Schulman et al. Economic Burden of Metastatic Bone Disease in the U.S. Cancer, 2007; 109(11):2334-2342.
3

Kurup AN, Callstrom MR. J Vasc Interv Radiol. 2010; 21(8 Suppl); S242-50.

4

Nielson et al. Bone Metastases: Pathophysiology and Management Policy. J Clin Oncol. 1991; 9(3):509-524.

5

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

6

Spiegel D, et al. Pain and depression in patients with cancer. Cancer, 1994; 74:2570-2578.

7

Wallace AN, Greenwood TJ, Jennings JW. Radiofrequency ablation and vertebral augmentation for palliation of painful spinal metastases. J Neurooncol. 2015; 124(1); 15; 707-712.

8

Cazzato RL, Garnon J, Caudrelier J, et al. Low-power bipolar radiofrequency ablation and vertebral augmentation for the palliative treatment of spinal malignancies. Int J Hyperthermia. 2018; 34 (8): 1282-1288.