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About this product

Division: International
Category: Vertebral Body Augmentation

The SYNFLATETM 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 body balloon, inflation system and an access kit.

SYNFLATE Vertebral Body 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

 

Features and Benefits
  • Semi-compliant balloon: Controlled and predictable inflation
  • 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
  • Inflation port with valve: One-step Catheter preparation using the vacuum syringe enclosed in the packaging
  • Broad shaft marker: Helps to identify proper advancement into working sleeve and vertebral body
  • Additional port for the stiffening wire: Stiffening wire gives rigidity to facilitate the insertion of the catheter. Optional removal for inf ation upon surgeons pref- erence
  • Cover sleeve: To refold the balloon for re-use. Catheter validated for re-use once in the same surgery
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Please refer to the surgical technique guide or package inserts if included 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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