Products

VertehighFix High Viscosity Spinal Bone Cement System

VertehighFix is indicated for the fixation of pathological fractures of bone using vertebroplasty and kyphoplasty. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

The product is divided two parts, bone cement and an injection tool.

  • Bone Cement:“VertehighFix” High Viscosity Spinal Bone Cement (TFDA No.006941)

Composition:The product contains a three-layer bag of powder polymer and a blister liquid ampoule of MMA.

REF

Powder

Liquid 

HSA0125

12.5 g

    5 mL

 

  • Injection tool:Bone cement mixing device and delivery system

The bone cement mixing device can blend the powder and liquid, transferring the mixture to the injection barrel. Subsequently, the injection port connects to the introducer needle, and the bone cement is extruded and injected into the vertebral body by the hydraulic pump. 

The delivery system is divided three-parts:  

    1. Hydraulic pump (ISD0160):Manual hydraulic pump
    2. The bone cement mixing device includes:two Funnels, a mixing barrel, barrel holder, mixing cap, mixing rod, adapter ring, cement syringe, transfer rod, and cement syringe cap
    3. Introducer needles:Introducer needle (Double-diamond, ISF0110, ISF0111), Introducer needle, Side-Firing (ISH0130, ISH0131), Biopsy needle (ISI0150), and Guide needle (ISJ0001)
  • VertehighFix should be stored in its original, unopened packaging, in a dry, clean place. Keep away from light and at a temperature of 25℃ maximum.

  • For controlled and optimal use of VertehighFix, the doses are to be stored at the intended operating room temperature for a minimum of 24 hours before use.

SPECIFICATION



 

Name &  Spec.

Bone Cement

Introducer Needle Kit

(Blister packaging)

VertehighFix High Viscosity Spinal Bone Cement

Hydraulic Pump

Bone Cement Mixing Device

Model of Parts

HSA0125

ISD0160

ISC0200

REF

HSA0100