About OsteoCool™ RF Ablation for Proceduralists

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 OsteoCool^TM 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 is invaded in 60-80% of patients with metastatic disease,²most frequently among patients with primary malignancies of the breast, prostate, and lung.³

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

Bone metastases can impact patients’ quality of life, producing complications such as pain, fractures, and decreased mobility.⁵In 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.⁷While 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 OsteoMap™ 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.

Case review

METASTATIC DISEASE CASE STUDY USING OSTEOCOOL

“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

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

IMAGES PRIOR TO ABLATION

T5 fracture
No neuropathy

ABLATION

T5 ablation

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

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Sabharwal T, Katsanos K, Buy X, Gangi A. Image-guided ablation therapy of bone tumors. Semin Ultrasound CT MRI. 2009;30(2):78-90.

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

Kurup AN, Callstrom MR. Ablation of skeletal metastases: current status. J Vasc Interv Radiol. 2010;21(Suppl 8); S242-S250.

⁴

Nielsen OS, Munro AJ, Tannock IF. Bone Metastases: Pathophysiology and management policy. J Clin Oncol. 1991; 9(3):509-524.

⁵

Goetz MP, Callstrom MR, Charboneau JW 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, Sands S, Koopman C. Pain and depression in patients with cancer. Cancer. 1994;74(9):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);111-118.

⁸

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

^{The views and opinions of the HCP expressed therein should be interpreted as personal views. They are completely independent and do not necessarily reflect the opinions of Medtronic}

^{See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu}