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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.

SYNFLATE Vertebral Balloon System | DePuy Synthes Companies SYNFLATE Vertebral Balloon System closeup | DePuy Synthes Companies
 

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

 
Features
Benefits
SYNFLATE Vertebral Balloon System sizes | DePuy Synthes Companies

SYNFLATE Vertebral Balloon System kit | DePuy Synthes Companies

Access Drill and Biopsy Kit | DePuy Synthes Companies
CONFIDENCE SPINAL CEMENT and VERTECEM II Bone Cement | DePuy Synthes Companies

SYNFLATE Vertebral Balloon Available in:

  • Small, 10mm
  • Medium, 15mm
  • Large, 20mm
Three sizes to fit varying patient anatomy
Two Radiopaque Markers

Provide X-ray visualization of the balloon for accurate placement

Low Profile 10G System Allows for access through smaller pedicles

Shaft Marker

Indicates proper advancement into access cannula and vertebral body

Inflation Port with Valve

Affords one-step catheter preparation using the enclosed vacuum syringe

10G Access Kits Available in Four Configurations:

  • Diamond Tip, End Opening Needle
  • Beveled Tip, End Opening Needle
  • Diamond Tip, Side Opening Needle
  • Beveled Tip, Side Opening Needle
Variety of tip and injection options to accommodate your surgical approach

Optional Accessories:

  • Access Drill, 10G
  • Biopsy Kit, 10G

 

Provide options to accommodate your surgical approach

Cement Delivery Options 

SYNFLATE Vertebral Balloon System works with both CONFIDENCE SPINAL CEMENT SYSTEM® and VERTECEM® II Bone Cement

 

DSUS/SPN/0416/1261 05/2016

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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