EkoSonic™ Endovascular System Brief Summary

Indications, Safety and Warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INDICATIONS FOR USE

The EkoSonic Endovascular System is indicated for the:

  • Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
  • Infusion of solutions into the pulmonary arteries.
  • Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent.

CONTRAINDICATIONS

  • Not designed for peripheral vasculature dilation purposes.
  • This system is contraindicated when, in the medical judgment of the physician, such a procedure may compromise the patient’s condition.

POTENTIAL COMPLICATIONS

  • Vessel perforation or rupture
  • Distal embolization of blood clots
  • Vessel spasm
  • Hemorrhage
  • Hematoma
  • Pain and tenderness
  • Sepsis/Infection
  • Thrombophlebitis
  • Tricuspid and pulmonic valve damage
  • Pulmonary infarct due to tip migration and spontaneous wedging, air embolism, and/or thromboembolism
  • Right bundle branch block and complete heart block
  • Intimal disruption
  • Arterial dissection
  • Vascular thrombosis
  • Drug reactions
  • Allergic reaction to contrast medium
  • Arteriovenous fistula
  • Thromboembolic episodes
  • Amputation
  • Pneumothorax
  • Perforation of the pulmonary artery.
  • Cardiac Arrhythmias – most frequently occurring during placement, removal or following displacement into the right ventricle.

 

PI-726201-AA

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