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VERTECEM®II Bone Cement
Available with SYNJECT™ Cement Delivery System or VERTECEM® V+ Syringe Kit
VERTECEM® II Bone Cement is a closed, sterile packed, and modular system offering 17 minutes of working time at 20°C. The cement is delivered remotely with SYNJECT™ Cement Delivery System or direct delivery with Vertecem® V+ Syringe Kit allowing control and tactical feedback for the physician.
VERTECEM® II Bone Cement is part of a complete procedure solution for the personalized treatment of vertebral compression fractures. VERTECEM® II Bone Cement is supplied sterile. The access instruments and delivery systems are supplied sterile and packaged separately. The a la carte offering allows for maximum economy, flexibility ad precise surgical planning.
Features & Benefits
Working Time
17 minutes of working time (at a standard OR temperature of 68°F/20°C)
Convenient and efficient
VERTECEM® II Bone Cement is a closed, sterile packed, and modular system available in kits to enable physicians to perform surgeries efficiently.
Radiopaque Cement
Radiopaque cement allows for visibility of cement placement under fluoroscopic monitoring.
Remote Delivery
SYNJECT™ Cement Delivery System is a hydraulic-based delivery system that allows for controlled and responsive cement flow with tactile feedback that keeps the physician out of the field of radiation.
Syringe Delivery
VERTECEM® V+ Syringe Kit has wide, integrated wings and reinforced syringe pistons to provide leverage, rigidity, and tactile feedback.
References
No available references for this product.
Indication Statement
INTENDED USE
The Vertecem® II Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
CONTRAINDICATIONS
The use of Vertecem® II Mixing Kit is contraindicated in the event of:
- acute or not completely healed local infections and active systemic infections
- treatment-refractory coagulopathy or during anticoagulation
- pulmonary insufficiency or severe heart and lung disorders
- vertebra plana or if safe percutaneous access to the vertebra is not guaranteed
- unstable vertebral fractures with involvement of the posterior margin
- previous damage to the pedicle wall
- fractures or neoplasia with narrowing of the spinal canal (more than 20%) and myelopathy
- retropulsing vertebral fragments with myelopathy
- acute traumatic fractures of non-osteoporotic vertebrae · a satisfactory response to conservative treatment
- asymptomatic stable vertebral fractures
- known hypersensitivity or allergy to one of the components of Vertecem II Mixing Kt
- pregnancy or lactation
Vertecem® II Mixing Kit is not suitable for use in joint arthroplasty.
Refer to the package inserts for complete system descriptions, indications, contraindications and warnings.
128056-191120 DSUS
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