OsteoCool HCP Brochure PMD017783 1.0 Pain Osteo Cool Scrollable Format

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TREAT SPINAL

METASTASES

WITH

REPRODUCIBLE

PRECISION

OsteoCool™ RF

Ablation System

YOUR

EXPERTISE

OUR

INNOVATION

The OsteoCool™ RF

Ablation System is

cooled radiofrequency

ablation technology. It

offers simultaneous, dual-

probe capabilities for the

treatment of metastatic

malignancies in the spine.

OsteoCool lets you treat

patients with painful spinal

metastases confidently and

consistently.

TOGETHER, WE CAN

TREAT CANCER PAIN

IN NEW WAYS,

SO PEOPLE

CAN LIVE BETTER

In 79% of patients with skeletal metastases,

the most frequent complaint is pain

associated with the disease1 — a pain that is

usually progressive and significantly reduces

quality of life.2

Metastatic lesions in the spine become

painful due to neural compression, pathologic

fracture, or other biochemical mechanisms.3

REPRODUCIBLE

PRECISION

KNOW WHERE THE HEAT

IS GOING

Coaxial, bipolar technology delivers

RF energy to the site consistently

§Algorithms designed to perform optimally in bone

§ Bone access kit defines anterior and posterior

ablation boundaries

§Confidence in ablation zone mapping

IT’S PREDICTABLE

Create large volume lesions without

excessive heating at the active tip

§ Minimize potential for char with internally cooled

ablation probe

§ Thermocouple monitors tissue temperature

around the distal tip of the probe

At a target temperature of 70° C at the distal tip, the

probes ablate for the pre-set time and yield predictable

ablation zones.

7 mm

PROBE ACTIVE TIP

ABLATION ZONE

SIZE AND DEFAULT TIME

11 x 10 mm

6:30 minutes

10 mm

PROBE ACTIVE TIP

ABLATION ZONE

SIZE AND DEFAULT TIME

17 x 13 mm

7:30 minutes

20 mm

PROBE ACTIVE TIP

ABLATION ZONE

SIZE AND DEFAULT TIME

29 x 21 mm

15:00 minutes

PROCEDURAL

FLEXIBILITY

Uni-pedicular

Bi-pedicular

Simultaneous ablation allows

two probes to be positioned

closely enough to produce

large ablation zones.

CUSTOMIZE YOUR ABLATION OPTIONS

OsteoCool provides exibility with a wide range of ablation

scenarios for your patient and procedural needs

Treat adjacent or multiple vertebral levels simultaneously:

§Bi-pedicular

§Uni-pedicular

§7mm, 10mm, and 20mm active tip sizes

§Multiple introducer gauge options

§Track ablation

DESIGN

SIMPLICITY

SIMPLIFY THE PROCEDURE

OsteoCool key design features

§User-friendly touch screen interface

§Recognizes probe size and automatically presets

ablation time

§Tracks temperature and power output to reduce risk

of thermal damage to adjacent structures

§Generates power levels specific to vertebral

lesion sizes

§Monitors impedance and automatically pauses

ablation before charring can occur

§Automatically halts RF energy delivery once ablation

time is complete

EXPERIENCE EFFICIENCY

§Use two probes at the same time

§Where indicated, use same bone access for

subsequent physician-directed procedure such as

cementoplasty (i.e., kyphoplasty or vertebroplasty)

Important Safety Information

The OsteoCool™ RF Ablation System is intended for

palliative treatment in spinal procedures by ablation

of metastatic malignant lesions in a vertebral body.

The system is contraindicated in patients with heart

pacemakers or other electronic device implants,

and contraindicated in vertebral body levels C1-C7.

The OsteoCool Bone Access Kits are indicated for

percutaneous access to bone.

UC201607326 EN ©2016 Medtronic Sofamor Danek USA, Inc. All Rights Reserved. PMD017783-1.0

Please see the package insert for the

complete list of indications, warnings,

precautions, and other important medical

information.

Consult instructions for use at this

website www.medtronic.com/manuals.

Note: Manuals can be viewed using a

current version of any major internet

browser. For best results, use Adobe

Acrobat® Reader with the browser.

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place

Memphis, TN 38132

(901) 396-3133

(800) 876-3133

Customer Service: (800) 933-2635

Medtronic

Spinal and Biologics Business

Worldwide Headquarters

2600 Sofamor Danek Drive

Memphis, TN 38132

www.medtronic.com

IMPORTANT SAFETY INFORMATION FOR KYPHON BALLOON KYPHOPLASTY

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.

REFERENCES

1. Janjan N, et al. Therapeutic guidelines for the treatment of bone metastasis: a report from the

American College of Radiology Appropriateness Criteria Expert Panel on Radiation Oncology. J Palliat

Med. 2009;12(5):417-426.

2. 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.

3. Wallace AN, Greenwood TJ, Jennings JW. Radiofrequency ablation and vertebral augmentation for

palliation of painful spinal metastases. J Neurooncol. 2015;124(1):111-118.