About this product
Division: Spine
Category: Vertebral Body Augmentation
The SYNFLATE™ Vertebral Balloon System provides a low profile, 10 G access and streamlined balloon preparation technique. The system also provides multiple needle tip and cement delivery options as well as a simple, easy-to-use inflation device.
The SYNFLATE Vertebral Balloon is part of a complete procedural solution for the personalized treatment of vertebral compression fractures. The a la carte offering allows for maximum economy, flexibility and precise surgical planning.
Indications for Use
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
Refer to the SYNFLATE package insert for complete system information including descriptions, indications, contraindications, and warnings.
Refer to specific Instructions for Use of the cement being used for complete system specific information including indications, contraindications, warnings, precautions, and adverse reactions related to bone cement.
Features & Benefits
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Features
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Benefits
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SYNFLATE Vertebral Balloon Available in:
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Three sizes to fit varying patient anatomy
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| Two Radiopaque Markers |
Provide X-ray visualization of the balloon for accurate placement |
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| Low Profile 10G System | Allows for access through smaller pedicles | |
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Shaft Marker |
Indicates proper advancement into access cannula and vertebral body |
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Inflation Port with Valve |
Affords one-step catheter preparation using the enclosed vacuum syringe | |
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10G Access Kits Available in Four Configurations:
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Variety of tip and injection options to accommodate your surgical approach | |
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Optional Accessories:
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Provide options to accommodate your surgical approach | |
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Cement Delivery Options |
SYNFLATE Vertebral Balloon System works with both CONFIDENCE SPINAL CEMENT SYSTEM® and VERTECEM® II Bone Cement |
All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative.
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