Treatment of Peripheral Arterial Hemorrhage With Lava LES (The LAVA Study)

Exclusion Criteria

• •Pregnancy or breast feeding. A woman who, in the Investigator's opinion, is of child-bearing potential must have a negative pregnancy test within 7 days before the index procedure;
• •Coexisting signs of peritonitis or other active infection;
• •Participation in an investigational study of a new drug, biologic or device that has not reached its primary endpoint at the time of study screening;
• •Uncorrectable coagulopathies such as thrombocytopenia \<40,000/ μL, international normalization ratio (INR) \>2.0;
• •Contraindication to angiography or catheterization, including untreatable allergy to iodinated contrast media;
• •Anatomic arterial unsuitability such that, in the Investigator's opinion, the delivery catheter cannot gain access to the selected position for safe and intended embolization;
• •Known allergy or other contraindication to any components of Lava LES including dimethyl sulfoxide (DMSO);
• •More than 4 Target Lesions will require embolization, in the Investigator's opinion after performance of diagnostic angiography or another suitable imaging study.