The Angel® Catheter Clinical Trial

Inclusion Criteria:

1. Subject or legally authorized representative is willing and able to provide written
informed consent,

2. Subject is 18 years or older,

3. Subject is expected to remain in a critical care setting for at least 72 hours,

AND at least one of the following inclusion criteria (4,5, and/or 6)

4. Subject has recognized contraindications to standard pharmacological
thromboprophylaxis including:

- Active bleeding or at high risk for bleeding OR

- Hypersensitivity to pharmacological thromboprophylaxis OR

- History of severe heparin induced thrombocytopenia OR

- Severe thrombocytopenia

5. Subject has a confirmed acute proximal lower extremities DVT or a confirmed acute PE
with recognized contraindication to anticoagulation

6. Subject requires a temporary interruption (>24 hours) of pharmacological
thromboprophylaxis for a surgical or medical procedure

Exclusion Criteria:

1. Subject is pregnant

2. Subject is in treatment with an investigational drug or device within 30 days prior
to enrollment

3. Subject has a pre-existing IVC filter in place

4. BMI = > 45

5. Subject has functioning pelvic renal allograft on the only side available for device
insertion

6. Subject has undergone a surgical procedure involving the femoral vein or pelvic veins
through which the device must be inserted

7. Anatomic inability to place the Angel® Catheter

8. Subject has known hypersensitivity to any of the components of the Angel® Catheter,
specifically Nitinol (nickel and/or titanium)