Cordis OPTA® Pro PTA Dilatation Catheter

Essential Prescribing Information

Indications

Cordis OPTA® Pro PTA Dilatation Catheter is intended for to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native synthetic arteriovenous dialysis fistulae.

Contraindications

  • None known for PTA procedure
  • Contraindicated for use in coronary arteries

Warnings

  • For single use only. DO NOT resterilize and/or reuse.
  • To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.
  • When the catheter is exposed to the vascular system, it should be used while under high-quality fluoroscopic observation.
  • Do not advance or retract the catheter unless the balloon is fully deflated.
  • If resistance is met during manipulation, determine the cause of the resistance before proceeding.
  • Do not exceed the balloons rated burst pressure. Use of a pressure monitoring device is recommended to prevent over-pressurization.
  • Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.

Precautions

  • Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.
  • For use only by appropriately trained physicians.
  • Consider the use of systemic heparinization. Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.
  • Do not attempt to pass the PTA catheter through a smaller size sheath introducer than indicated on the label.
  • Not intended for precise arterial blood pressure monitoring.

Adverse Events

  • Possible adverse events include, but are not limited to:
    • Air embolism
    • Aneurysm
    • Hematoma at the puncture site
    • Perforation of the heart or vessel wall

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
See package insert for full product information.