Control. Control Through VISCOSITY Control Through DELIVERY Control Through SIMPLICITY
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1 Control. Now that s CONFIDENCE. Control Through VISCOSITY Control Through DELIVERY Control Through SIMPLICITY
2 Control throughviscosity Controlled Fill Cement Interdigitation Low viscosity cement Trabecular structure CONFIDENCE High Viscosity Cement CONFIDENCE High Viscosity Cement The proprietary CONFIDENCE Spinal Cement is designed to provide a controlled, more even fill than that of a low viscosity cement. 1 The high viscosity properties of the CONFIDENCE Cement is designed to allow for interdigitation, preserving the remaining trabecular structure of the vertebral body. High Viscosity Without the Wait The CONFIDENCE High Viscosity Spinal Cement provides immediate post mixing high viscosity with optimal working time when compared to a major competitor. CONFIDENCE High Viscosity Cement (20ºC) DOUGH TIME (mix, transfer, wait) WORKING TIME SETTING TIME Time (in minutes) CONFIDENCE vs. KyphX HV-R Viscosity (PaS) CONFIDENCE working viscosity CONFIDENCE Cement KyphX HV-R CONFIDENCE achieves high viscosity immediately after mixing. CONFIDENCE stays at a constant high viscosity for 9 minutes. KyphX has a constantly changing viscosity throughout its working time (8 to 16 minutes). KyphX has a short injection time at a viscosity comparable to CONFIDENCE Time from start of mixing (in minutes) Tested at 22ºC (72ºF) per KyphX HV-R Instructions for Use Proprietary High Viscosity Cement Composition The dough-like consistency of the CONFIDENCE High Viscosity Spinal Cement is designed to reduce the potential for leakage within the vertebral body. 1 Unique high viscosity polymethylmethacrylate based cement 1 Baroud G, Crookshank M, Bohner M. High-viscosity cement significantly enhances uniformity of cement filling in vertebroplasty: an experimental model and study on cement leakage. Spine 2006;31: Front cover x-ray courtesy of David Mitchell M.D., Spartanburg SC Inside x-ray courtesy of GC Anselmetti M.D., Turin ITALY
3 Control throughdelivery Hydraulic based delivery system allows for a controlled flow of highly viscous cement through a small gauge introducer needle. Rotational quick connect for optimal adjustability Ergonomic hand operated pump delivers a controlled amount of cement (.318cc per full turn) Water activates piston to begin a controlled flow of cement Transparent cement with volumetric reference markings Pump is pre-filled with sterile water Secure luer lock connection Long flexible tube reduces physician radiation exposure Side hole needle allows directional placement of cement. Introducer needle has multiple tip, gauge and length configurations Low pressure at the needle tip
4 Control through Simplicity Novel mixing and transfer tools allow for simple streamlined set up. Seamless mixing and transfer in one bowl Contained cement transfer designed to limit vapors seconds of mixing achieves optimal viscosity Simple one step transfer of cement into reservoir Transfer mechanism auto fills reservoir
5 A Novel Treatment for Vertebral Compression Fractures
6 INDICATIONS The CONFIDENCE SPINAL CEMENT SYSTEM is intended for percutaneous delivery of CONFIDENCE Spinal Cements, which are indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma). CONTRAINDICATIONS The use of CONFIDENCE High Viscosity Spinal Cement is contraindicated in patients presenting with any of the following conditions: Use of CONFIDENCE High Viscosity Spinal Cement for prophylaxis (such as in metastatic or osteoporotic patients with no evidence of acute vertebral fracture) Coagulation disorders, or severe cardiopulmonary disease. Haemorrhagic diasthesis. Non-pathological, acute, traumatic fractures of the vertebra. Patient clearly improving on medical therapy. Spinal stenosis (> 20% by retropulsed fragments). Compromise of the vertebral body or walls of the pedicles. Compromise or instability of vertebral fractures due to posterior involvement. Anatomical damage of the vertebra that prevents safe access of the needle to the vertebral body. Vertebral body collapse to less than 1/3 (33%) original height. Vertebral plana (collapse >90%) Active or incompletely treated infection. Coagulopathy or inability to reverse anti-coagulant therapy (both during and approximately 24 hours post-procedure). Severe pulmonary insufficiency. Allergic reaction to any of the components of the CONFIDENCE High Viscosity Spinal Cement.. Limited Warranty and Disclaimer: DePuy Spine products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. WARNING: In the USA, this product has labeling limitations. See package insert for complete information. CAUTION: USA Law restricts these devices to sale by or on the order of a physician. DEPUY SPINE and the DePuy Spine logo are trademarks of DePuy Spine, Inc. CONFIDENCE SPINAL CEMENT SYSTEM is a registered trademark of DePuy Spine, Inc. Not all products are currently available in all markets DePuy Spine, Inc. All rights reserved. To order, call DePuy Spine Customer Service ( ). KyphX HV-R is a registered trademark of Kyphon, Inc. DePuy Spine, Inc. 325 Paramount Drive Raynham, MA USA Tel: +1 (800) VB /09 JC/RPI
DePuy International Ltd St Anthony s Road Leeds LS11 8DT England Tel: +44 (0) Fax: +44 (0)
Reference: 1. Data on file at DePuy Spine TM 2008 DePuy Spine International is a joint venture with Biedermann Motech, GmbH. This publication is not intended for distribution in the USA. X-ray on front
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