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Embozene™ Microspheres

Indications, Safety, and Warnings

Prescriptive Information

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.

INTENDED USE/INDICATIONS FOR USE

Embozene Microspheres  are indicated  for embolization of arteriovenous malformations  (A.V.M.) and hypervascular tumors (H.V.T.) including uterine fibroids and hepatoma.

CONTRAINDICATIONS

The contraindications  of Embozene Microspheres include the presence of vasculature where EmbozeneTM Microspheres could pass directly into the central nervous system, central circulatory system, internal carotid artery, or other non-target territories.  Procedures should not be performed if vascular anatomy precludes correct catheter placement or embolic injection.

WARNINGS and PRECAUTIONS

Vascular embolization is a high-risk procedure. The procedure should be performed by specialized physicians trained in vascular embolization procedures. Complications can occur at any time during or after the procedure.

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