(HALT) Embrace Hydrogel Embolic System (HES) Study of Embolization in Peripheral Arterial Bleeds

Inclusion Criteria:

1. Male or female patients age ≥ 18 years old

2. Subjects who are candidates for transarterial catheter embolization with arterialbleeding documented on a suitable radiologic imaging and/or endoscopic visualizationstudy taken during the index hospitalization that allows for the source of thearterial injury/bleeding to be localized. Includes (but not limited to) thefollowing:

3. Non-variceal Upper Gastrointestinal (UGI) bleeds refractory to endoscopictreatment

4. End organ/visceral bleeds (kidney, liver and spleen including tumor bleeds)

5. Spontaneous hematoma (e.g., rectus sheath and psoas muscle hematomas)

6. Other peripheral arterial bleeds (e.g., pelvic hemorrhage) if not associatedwith risk of ischemia distal to the lesion or embolization of non-expendablearteries.

7. Subjects with at least one target vessel ≤6mm and Embrace HES can be delivered tothe target vessel(s).

8. Subject is willing to comply with follow-up evaluation schedule.

9. No prior embolization in the target territory prior to study entry

10. The subject or a legally authorized representative has provided informed consentapproved by the appropriate local IRB/EC.

Exclusion Criteria:

1. Life expectancy ≤ 30 days

2. In the Investigator's opinion, due to injury severity the subject is not likely tobenefit from angioembolization (e.g., in the presence of significant polytrauma,multiple organ failure or shattered organs).

3. Any contraindication to arteriography or the embolization protocol utilized attreating institution.

4. Pregnant or breast-feeding (women of child-bearing potential must undergo apregnancy test performed in accordance with local institutional requirements andagree to use contraception for at least six months).

5. Hemorrhagic shock (Class IV-see Appendix 1) at time of treatment

6. Target vascular territory supplied by the pulmonary artery, coronary artery, orcerebral or cerebellar artery (requiring embolization of these arteries) or theartery to be embolized has connections to these arteries via a collateral pathway.

7. Embolization for treatment of spinal arteries, lower GI bleeds, arteriovenousmalformations, embolization of arteriovenous shunts, endoleak management,neurovascular bleeds, penetrating trauma of extremities.

8. Forrest Classification Type III UGI bleeds (see Appendix 2)

9. In the investigator's opinion, patient will require embolization of 4 or morediscrete vascular territories/arterial injuries (requires that microcatheter berepositioned to discrete area) based on diagnostic angiography or another suitableimaging study.

10. Known or suspected angio-anatomical conditions that in the Investigator's opinion,would prevent the delivery catheter to gain access to the selected position for safeand intended embolization.

11. Known allergies (based on history) to PEG, ferrous compounds, tert ButylHydroperoxide, contrast media or procedural sedatives/anesthetics that is notamenable to pre-medication

12. Presence of medically relevant localized or systemic infection

13. The patient has other concurrent conditions or known history that in the opinion ofthe Investigator would be unlikely to receive clinical benefit from the studyprocedure or participation in the study may compromise patient safety or studyobjectives (including but not limited to ongoing acute infection, life-threateningconcomitant trauma or conditions).

14. Presence of Uncorrectable Coagulopathy: Defined as thrombocytopenia with plateletcounts < 40,000/mm3 and/or INR > 2.0.

15. If known, enrollment in a concurrent study in which the study treatment may confoundthe evaluation of the study device.