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SYNFLATE SYSTEM

SYNFLATE SYSTEM
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For the Attention of the Operating Surgeon: IMPORTANT INFORMATION ON THE DEPUY SYNTHES SYNFLATE SYSTEM DESCRIPTION The Synflate Vertebral Balloon is part of a modular system including an inflation system, a variety of access instruments, a biopsy kit, an access drill and implant options. All instruments and implants are available separately. This allows for maximum economy, flexibility, and precise surgical planning. Refer to the surgical technique guide for a full list of compatible instruments and implants. The Synflate Vertebral Balloon contains the following components: 1. Balloon-catheter 2. Stiffening wire 3. Syringe with Luer lock Once access is obtained, the Synflate Vertebral Balloon, attached to an inflation system, is used to reduce fractures and/or create a void in the cancellous bone of the vertebral body. The access instruments and inflation system are designed specifically for use with the Synflate Vertebral Balloon device. Alternate instrumentation should not be used with the Synflate Vertebral Balloon device. Refer to the corresponding Instructions for Use for the access instruments and inflation system for additional details regarding these devices. Additionally, adhere to the Instructions for Use for the specific PMMA based bone cement used during the procedure. The Synflate Vertebral Balloon, inflation system and access instruments are supplied sterile and packaged separately. The Synflate System has not been evaluated for safety and compatibility in the MR environment. The Synflate System has not been tested for heating or migration in the MR environment. Read the surgical technique guide carefully prior to use. To obtain a copy of the Synflate Surgical Technique Guide, contact your local DePuy Synthes sales representative. INDICATIONS The Synflate Vertebral Balloon System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty. CONTRAINDICATIONS • Instability of posterior wall and/or pedicles • Infection • Severe bleeding • Known allergies to bone cement • Pregnancy • Fractures in which more than 75% of vertebral height is lost • Any known severe allergy to contrast material • When safe placement and inflation of the balloon is not possible due to vertebral dimensions or fracture pattern. WARNINGS The manufacturer is not responsible for any complications arising from incorrect diagnosis, choice of incorrect bone filler, incorrectly combined components and/or operating techniques, the limitations of treatment methods, or inadequate asepsis. This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is

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It is the responsibility of the physician performing this procedure to determine the appropriateness of the product and specific techniques. − Do not leave the balloon implanted; the balloon material is not implant grade material. Breakage of the balloon or any part of the Synflate System (i.e. access instruments) may require intervention or retrieval. − Do not use air and/or other gas to inflate the balloon. Use only liquid contrast medium to inflate the balloon as indicated. − Do not inflate the balloon until it has been fully deployed in the vertebral body. Inflating the balloon prior to...

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For a transpedicular approach, if the pedicle is not large enough or stable enough to withstand the procedure, pedicle fracture may occur. When using bone cement, refer to the specific Instructions for Use for indications, contraindications, warnings, precautions, and adverse events related to bone cement. Inflation Chart (maximum recommended) 03.804.700S, Small Unconstrained Inflation Chart (unconstrained test conditions) 03.804.700S, Small Inflation Volume Inflation Pressure The device components should be stored in their original packaging and should not be removed from the protective...

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SYNFLATE SYSTEM 3Pages

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SYNFLATE SYSTEM
3Pages