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About this product

Division: Spine
Category: Vertebroplasty

The CONFIDENCE SPINAL CEMENT SYSTEM® combines unique highly viscous cement with a novel hydraulic delivery system. The radiopaque CONFIDENCE System reaches a dough-like phase immediately after the cement components have been mixed, without going through a liquid phase. The hydraulic delivery system enables a smooth introduction of the highly viscous cement into the vertebral body.

The CONFIDENCE System 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.

CONFIDENCE SPINAL CEMENT SYSTEM | DePuy Synthes Companies CONFIDENCE SPINAL CEMENT SYSTEM | DePuy Synthes Companies CONFIDENCE SPINAL CEMENT SYSTEM | DePuy Synthes Companies
 

Indications for Use

INDICATIONS

 

The CONFIDENCE SPINAL CEMENT SYSTEM is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

 

CONTRAINDICATIONS

 

The use of Confidence Spinal Cement is contraindicated in patients presenting with any of the following conditions:

 

  • Use of CONFIDENCE Spinal Cement for prophylaxis (such as in metastatic or osteoporotic patients with no evidence of acute vertebral fracture)
  • Coagulation disorders, or severe cardiopulmonary disease.
  • Haemorrhagic diasthesis.
  • Non-pathological, acute, traumatic fractures of the vertebra.
  • Patient clearly improving on medical therapy.
  • Spinal stenosis (> 20% by retropulsed fragments).
  • Compromise of the vertebral body or walls of the pedicles.
  • Compromise or instability of vertebral fractures due to posterior involvement.
  • Anatomical damage of the vertebra that prevents safe access of the needle to the vertebral body.
  • Vertebral body collapse to less than 1/3 (33%) original height.
  • Vertebral plana (collapse >90%).
  • Active or incompletely treated infection.
  • Coagulopathy or inability to reverse anti- coagulant therapy (both during and approximately 24 hours post-procedure).
  • Severe pulmonary insufficiency.
  • Allergic reaction to any of the components of the CONFIDENCE Spinal Cement.

 

WARNING:  This product has labeling limitations.  See package insert for additional warnings, precautions and possible adverse effects.

 

CAUTION: USA law restricts this device to sale by or on the order of physician.

Features & Benefits

  Features Benefits
CONFIDENCE SPINAL CEMENT SYSTEM | DePuy Synthes Companies

CONFIDENCE SPINAL CEMENT SYSTEM | DePuy Synthes Companies

CONFIDENCE SPINAL CEMENT SYSTEM | DePuy Synthes Companies

CONFIDENCE SPINAL CEMENT SYSTEM | DePuy Synthes Companies

High viscosity cement Reduced risk of extravasation
Hydraulic based delivery system Controlled flow of highly viscous cement through a small gauge introducer needle
Remote delivery system Reduced radiation exposure
Ready to use upon mixing Decreased OR time and stress around timing the mix
10G, 11G, 13G or 15G introducer needles Access through large and small pedicles throughout the spine
DSUS/SPN/0416/1262 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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