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SYNFLATE® Vertebral Balloon
The SYNFLATE® Vertebral Balloon System is intended for the reduction of fractures and/or creation of a void in cancellous bone in the spine. The system is used during vertebral augmentation procedures (kyphoplasty).
The system consists of the SYNFLATE vertebral balloon, inflation system and an access kit.
SYNFLATE Vertebral Balloon
- 3 standard balloon sizes: covers a large anatomical range
- Low profile: 10 G access
- 2 radiopaque markers: For X-ray visualization of the balloon to facilitate accurate placement
Vertebral Augmentation Access Kit
- Small access diameter: 10G
- Access options include guide wire and direct trocar approach
- Percutaneous, minimally invasive approach
- Intraoperative balloon sizing
- Biopsy option
The system is indicated to be used with a legally-marketed bone filler adequately indicated for use in vertebroplasty or vertebral augmentation procedures.
Features & Benefits
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Semi-compliant balloon
Controlled and predictable inflation
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Three standard balloon sizes
Covers a large anatomical range
-
Low profile
10 G access
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Inflation port with valve
One-step Catheter preparation using the vacuum syringe enclosed in the packaging
References
No available references for this product.
Indication Statement
For product details such as indications, contraindications, warnings and precautions please consult the IFU.
110553-190328
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