Indications & instructions for use

 



Indications for use:

FDA CLEARED INDICATIONS: The EkoSonic® Endovascular System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.  The EkoSonic® Endovascular System is intended for the infusion of solutions into the pulmonary arteries.  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. 

Contraindications:

Not designed for peripheral vasculature dilatation purposes.  The system is contraindicated when, in the medical judgement of the physician, such procedure may compromise the patient’s condition.  See device instructions for use for complete prescribing information.

   
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