Treatment of Peripheral Arterial Hemorrhage With Lava LES (The LAVA Study)
Treatment of Peripheral Arterial Hemorrhage With Lava LES (The LAVA Study)
To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of
 arterial hemorrhage in the peripheral vasculature.
Inclusion Criteria:

 -  Age ≥18 years;

 -  Active arterial bleeding in the peripheral vasculature, documented on a suitable
 imaging study;

 -  Subject or subject's legally authorized representative is able and authorized to
 provide written informed consent for the procedure and the study;

 -  Subject is willing and able to comply with the specified follow-up evaluation
 schedule;

 -  Life expectancy >30 days;

 -  No prior embolization in the target territory.

 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.