Angel® Catheter Post Market Registry
Angel® Catheter Post Market Registry
This is a post-market, observational, retrospective multi-center Registry designed to gather
 information on the performance of the Angel® Catheter in general clinical practice.
The Registry population will include all consecutive patients in whom the Angel® Catheter is
 placed at participating sites. Information about the use of the catheter will be collected
 from placement through three days after device removal, or through death or discharge,
 whichever occurs first. Date of discharge/transfer from the Critical Care Unit will also be
 collected, completing the defined registry observation.

 Information on up to 2,000 patients will be abstracted from a patient chart review. Sites
 will be asked to record data on all Angel® Catheter placements in their institution starting
 with their first Angel® Catheter placement after training by BiO2 Medical, Inc. personnel
 once all necessary institutional approvals are obtained confirming that Informed Consent is
 not required from the patient or LAR to collect, use, or publish patient data from this
 registry.

 The registry population will include all consecutive patients in whom the Angel® Catheter is
 placed, or there has been an attempt to place, at selected Registry sites. The Instructions
 for Use (IFU) for the Angel® Catheter include the following indications:

 -  Pulmonary thromboembolism when anticoagulants are contraindicated; or

 -  Failure of anticoagulant therapy in thromboembolic diseases; or

 -  Emergency treatment following massive pulmonary embolism where anticipated benefits of
 conventional therapy are reduced; and or

 -  Critically ill patients at high risk of pulmonary embolism, not receiving medical
 thromboprophylaxis due to either increased risk of bleeding, active bleeding or heparin
 induced thrombocytopenia.

 Since the Angel® Catheter is indicated for use in pregnant patients, patients who are
 pregnant may be included in this Registry after the proper risks and benefits have been
 assessed by the physician.

 In summary, the Registry Event Schedule and data collection includes the following:

 -  Demographics and Current Medical Condition: Information collected to include
 demographics, medical condition and indication/s for use of the Angel® Catheter as
 recorded in the patient chart.

 -  Device Placement: Placement procedure data will be collected. If the catheter cannot be
 placed for some reason, no further follow up information will be collected on these
 patients.

 -  Angel® Catheter Indwelling experience: While the Angel® Catheter is in place during the
 patient's hospital stay, information regarding anticoagulation use (eCRF form #9), any
 complications, clinically significant PE, lower extremity DVT will be collected through
 three days after device retrieval, discharge from the hospital, or death, whichever
 occurs first.

 -  Device Retrieval: Information on ease of catheter retrieval and other key aspects will
 be collected.

 -  Registry Exit: Information about the patient's status at three days post device removal,
 death, or discharge from the hospital, whichever occurs first will be collected. The
 patient's date of discharge/transfer from the Critical Care Unit will also be collected.

 -  Anticoagulation Therapy: Information about the use of anticoagulation throughout the
 patient's observation period will be collected.
Inclusion Criteria:

 -  All consecutive patients in whom the Angel® Catheter is placed, or there has been an
 attempt to place.

 Exclusion Criteria:

 -  N/A