enVast Instructions for Use
Indication for Use
enVast is indicated for the non-surgical removal of thrombus burden from coronary blood vessels and for use with adjunctive aspiration and with the injection or infusion of contrast media and other fluids.
Precaution:
The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) have not been established. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention
CAUTION:
Federal (US) law restricts these device(s) to sale by or on the order of a physician. Please refer to Instructions for Use for indications, contraindications, warnings, and precautions.
