Indications & instructions for use

 

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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. FDA Indications: Taiwan, Thailand, Malaysia, Singapore, Phillippines, Vietnam.

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. CE Indications: Australia, New Zealand, Hong Kong.

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.

Instruction for Use:

Control Unit Instructions for use
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       EkoSonic Instructions for use
Dutch German
Norwegian Turkish
Swedish French
Danish Polish
Italian Finnish
Czech Spanish (Europe)
Slavic Spanish (Latin America)
 
  EkoSonic PE Instructions for use
Dutch German
Norwegian Turkish
Swedish French
Danish Polish
Italian Finnish
Czech Spanish (Europe)
Slavic Spanish (Latin America)