Angel® Catheter Early Feasibility Clinical Study

STUDY ENDPOINTS 1. Primary Endpoints: a. Initial Insights into Safety * Success in delivery, maintenance and removal of the Angel® Catheter. * Incidence and seriousness of all adverse events. * Incidence of device or procedure-related adverse events. 2. Secondary Endpoints: * Evaluation of the separate and combined functions of the IVC filter and the central venous catheter device. * Evaluate investigative site's ability to comprehend the procedural steps (Per the Insertion Procedure, the Repositioning Procedure, and the Removal Procedure) * Evaluate operator challenges with device use (human factors). * Evaluate success and challenges encountered in conducting a pivotal trial in critically ill patient population - including but not limited to Informed Consent and enrollment. ENROLLMENT AND SUBJECT SAMPLE SIZE The study is expected to enroll up to 20 subjects in up to 4 US investigational sites with a goal for 10 evaluable subjects in whom Angel® Catheter placement has been attempted. STUDY DURATION The device is designed to be deployed for less than 30 days. After enrollment and Angel® Catheter placement, subjects will be followed daily through the post-removal, seven (7) day follow up or until hospital discharge, whichever occurs first.