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SYNFLATE® Vertebral Balloon System
SYNFLATE® Vertebral Balloon System
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.
SYNFLATE® Vertebral Balloon is part of a complete procedure solution for the personalized treatment of vertebral compression fractures. The SYNFLATE® Vertebral Balloon is supplied sterile. The access instruments are supplied sterile and packaged separately. An a la carte offering allows for maximum economy, flexibility and precise surgical planning.
Key Resources
Instructions for Use
Features & Benefits
Available in three sizes:
The SYNFLATE® Vertebral Balloon available in Small (10mm), Medium (15mm), and Large (20mm) to fit varying patient anatomy.
Double lumen catheter:
Double lumen catheter: Outer lumen for inflation and Inner Lumen for optional stiffening wire
Two Radiopaque markers:
Two Radiopaque markers inside the balloon catheter to facilitate accurate placement of the balloon through X-Ray visualization
Marker bands
Marker bands on the catheter shaft that corresponds to the balloon length and helps identify proper advancement in working cannula and vertebral body
References
No available references for this product.
Indication Statement
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 package inserts for complete system descriptions, indications, contraindications and warnings.
128057-191120 DSUS
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