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.

SYNFLATE® Vertebral Balloon

Features & Benefits

  • Semi-compliant balloon:

    Semi-compliant balloon

    Controlled and predictable inflation

  • Three standard balloon sizes:

    Three standard balloon sizes

    Covers a large anatomical range

  • Low profile

    Low profile

    10 G access

  • Inflation port with valve

    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