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

Liquid Embolization of Arterial Hemorrhages in the Peripheral Vasculature: 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.