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LAVA®

Approved Indication

LAVA LES is indicated for embolization of arterial hemorrhage in the peripheral vasculature.

Please consult the contraindications, warnings, and precautions in the Package Insert:

Package Insert (IFU)

Caution: U.S. federal law restricts the sale, distribution, and use of this product to physicians or as prescribed by a physician. This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures, and the physician would have successfully completed training. Indications for Use: LAVA® LES is indicated for embolization of arterial hemorrhage in the peripheral vasculature. Potential Complications: Potential adverse effects (e.g., complications) associated with the use of the device include: Non-target embolization, Ischemia or infarction of the target territory, Allergic reactions to device components, Catheter breakage, Catheter entrapment, Inadvertent embolization of a non-target vessel or territory, Embolization of device components, Access site hematoma or ecchymosis, Access site false aneurysm, Pain at access site, Arterial dissection, Mural thrombus formation, Vessel perforation, Hemorrhage, Recanalization, Vessel perforation, Arteriovenous fistula, Distal atheroembolism, Infection, Sepsis, Serous drainage, Lymphorrhea, Leg edema, Leg pain, and Back pain. Consult the Instructions for Use for a complete listing of indications, contraindications, potential complications, warnings, and precautions.