OsteoCool HCP Brochure PMD017783 1.0 Pain Osteo Cool Scrollable Format
2016-08-22
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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, dualprobe 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 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 IT’S PREDICTABLE Create large volume lesions without excessive heating at the active tip §§ M inimize 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. PROCEDURAL FLEXIBILITY CUSTOMIZE YOUR ABLATION OPTIONS OsteoCool provides flexibility 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 Bi-pedicular Simultaneous ablation allows two probes to be positioned closely enough to produce large ablation zones. Uni-pedicular 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. 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. Medtronic Spinal and Biologics Business Worldwide Headquarters 2600 Sofamor Danek Drive Memphis, TN 38132 Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133 (800) 876-3133 Customer Service: (800) 933-2635 www.medtronic.com 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. UC201607326 EN ©2016 Medtronic Sofamor Danek USA, Inc. All Rights Reserved. PMD017783-1.0 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.
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