Indications & instructions for use

 



Indications for use:

US FDA CLEARED INDICATIONS: 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; the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature; and the infusion of solutions into the pulmonary arteries. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. 

CE Mark: The Ekosonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. Intended for the treatment of pulmonary embolism patients with ≥ 50% clot burden in one or both main pulmonary arteries or lobar pulmonary arteries, and evidence of right heart dysfunction based on right heart pressures (mean pulmonary artery pressure ≥ 25 mmHg) or echocardiographic evaluation.

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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