OsteoCool™ RF Ablation

UC201903661 EN 2018 Medtronic Sofamor Danek USA, Inc. All rights reserved. PMD021532-2.0

TOGETHER, WE CAN TREAT CANCER PAIN IN NEW WAYS, SO PATIENTS CAN LIVE BETTER

Bone is invaded in 60% to 80% of patients with metastatic disease1 — most frequently among patients with primary malignancies of the breast, prostate, and lung.2

The most frequent complaint of patients with skeletal metastases is the pain associated with the disease — occurring in 79% of patients.3 The pain is usually refractory and affects quality of life.4

Bone metastases can significantly impact patients’ quality of life with pain, fractures, decreased mobility, depression,5 and anxiety.6

And with patients living longer with their cancer, more are suffering from metastatic disease pain.1,2

CANCER PAIN RELIEFA CLINICAL CHALLENGE

RADIATION THERAPY — THE GOLD STANDARDPartnering to elevate the standard of care

Radiation therapy (RT) is the gold standard palliative treatment for patients with bone metastases.

But there may be patients who cannot or do not benefit from RT as the only treatment for pain palliation.

Based off your current protocol, how do you treat patients who have trouble receiving radiation due to pain?

IMPROVED PAIN RESPONSEDi Staso, et al, showed that patients who received radiofrequency ablation (RFA) in conjunction with RT, vs. RT alone, for bone metastases palliation received:7*

6 weeks faster pain response

33% increase in overall pain response p = 0.048

RT AND RADIOFREQUENCY ABLATION — EXPLORE THE SYNERGY

OVERALL PAIN RELIEF

59% OF PATIENTSwho received radiation therapy alone

Study limitations � Small, non-randomized and non-concurrent

comparison

� Cohort not well matched for sites treated

� Interpret comparative effectiveness with caution

93% OF PATIENTSwho received radiation therapy and radiofrequency ablation

n = 30

n = 15

Overall pain relief

Continued pain

* RFA therapy used: Leveen Needle Electrode (Boston Scientific Corp.)

Thinking about patients experiencing pain in your practice today, who might benefit from adjunctive RFA?

EARLY PAIN RELIEFA recent retrospective study by Cazzato, et al., found that patients treated with a combination of RFA and vertebral augmentation experienced significant pain relief.8

PAIN RELIEF AFTER RFA* + VERTEBRAL AUGMENTATION8

0

1

2

3

4

5

6

7

8

Before After

p < 0.01

Study limitations8

� Small sample size

� Retrospective analysis

� Absence of an augmentation-only control group

When radiation alone may not be enough � Because radiation hardens bone, the National

Comprehensive Cancer Network (NCCN) Bone Health Task Force propose radiation after augmentation9

� RT alone provides potential pain relief but doesn’t prevent vertebral collapse8

� Pain relief with RT is temporary in terms of complete and partial response7

� Recurrent pain, previously irradiated, usually cannot be treated with additional RT7

RFA + Augmentation + Radiation � RFA is not meant to oppose or replace

standard treatments

� As a stand-alone or complementary option to radiation, RFA is an option for your patients with painful bone metastases7

� Subsequent augmentation stabilizes the fracture

* RFA therapy used: OsteoCool™ RF Ablation M

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Last clinical follow-up: 1.9+-1.4 monthsMean pain score: 3.5+-2 at follow-up versus 7.8+-1.1 at baselineN=11

Vertebral Augmentation � For patients with vertebral

compression fracture due to cancer, balloon kyphoplasty or vertebroplasty commonly follow the OsteoCool™ RF ablation procedure

� Use the same access tools for OsteoCool™ RF ablation and subsequent vertebral augmentation where indicated Stabilization

MEET PROCEDURE GOALSWITH INTEGRATED THERAPY

What measures do you take to treat painful pathologic fractures in your practice?

PROCEDURE GOALS The primary goals of any therapy for patients with metastatic disease in the vertebral body are to:10

� Achieve pain relief � Preserve neurologic function � Restore mechanical stability

PAIN IS MULTIFACETEDWhile some pain derives from biological sources such as cytokine release, other pain sources are mechanical:

� Fracture and tumor periosteal pressure � Tumor impingement on neural structures

OsteoCool™ RF Ablation � Minimally invasive procedure for

the treatment of metastatic bone tumors

� Internally cooled ablation probes can create large volume lesions without excessive heating at the active tip

� Simultaneous ablation allows two probes to be positioned closely enough to produce large ablation zones

� OsteoCool probes are available in 7, 10, 15 and 20 mm active tips, providing various size options to support clinical need

INDICATIONS AND RISKSThe OsteoCool™ RF Ablation System is intended for the palliative treatment in spinal proedures by ablation of metastatic malignant lesions in a vertebral body. It is also intended for 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 system include damage to surrounding tissue through iatrogenic injury as a consequence of electrosurgery, pulmonary embolism, nerve injury including thermal injury, puncture of the spinal cord or nerve roots potentially resulting in radiculopathy, paresis, and paralysis. The OsteoCool™ bone access kits are indicated for percutaneous access to bone.

Bone tumor ablation

BKP RISKSKyphon™ BKP is a minimally invasive procedure for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesion. The complication rate with Kyphon™ BKP 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.

UC201903661 EN 2018 Medtronic Sofamor Danek USA, Inc. All rights reserved. PMD021532-2.0

Please see the package insert for the complete list of indications, warnings, precautions, and other important medical information.

Consult instructions for use at this websitemedtronic.com/manuals.

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Through collaboration, we can help patients live better days.Learn more at Medtronic.com/oncologypartnership

REFERENCES1. Schulman KL, Kohles J. Economic burden of metastatic bone disease in the U.S. Cancer. 2007;109(11):2334-2342.

2. Kurup AN and Callstrom MR. Ablation of Skeletal Metastases: Current Status. J Vasc Interv Radiol. 2010;21(8 Suppl);S242-50.

3. Janjan N, Lutz ST, Bedwinek JM, et al. Therapeutic guidelines for the treatment of bone metastases. J Palliat Med. 2009;12(5):417-426.

4. Nakatsuka A, Yamakado K, Maeda M, et al. Radiofrequency ablation combined with bone cement injection for the treatment of bone malignancies. J Vasc Interv Radiol. 2004;15:707-712.

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

6. Goetz, et al. Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol. 2004;22:300-306.

7. Di Staso M, Zugaro L, Gravina GL, et al. A feasibility study of percutaneous radiofrequency ablation followed by radiotherapy in the management of painful osteolytic bone metastases. Eur Radiol. 2011;21(9):2004-2010. doi: 10.1007/s00330-011-2133-3. Epub 2011 May 1.

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;Jan 18:1-7. doi: 10.1080/02656736.2017.1422557. [Epub ahead of print] PMID: 29347855.

9. Gralow JR, Biermann JS, Farooki A. NCCN Task Force Report: Bone Health in Cancer Care. JNCCN. 2013;11(Supp 3):S1-S51.

10. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers. V.1.2018. National Comprehensive Cancer Network, Inc 2018. All rights reserved. Accessed March 20, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

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