A Pivotal Study to Evaluate the Safety and Effectiveness of RMT Medical Technology's SafeFlo® Vena Cava Filter

Inclusion Criteria: * Traditional indications for vena cava filter in patients with established DVT or PE, including (40): * Patients with proven Pulmonary Embolus (PE) or Deep Vein Thrombosis (DVT) and one or more of the following: 1. Contraindication to anticoagulation 2. Complication of anticoagulation 3. Failure of anticoagulation * Recurrent PE despite adequate anticoagulation therapy * Inability to achieve adequate anticoagulation 4. Poor compliance with anticoagulation medications * Extended indications for vena cava filter placement in patients with established DVT or PE, including the following (31, 40): * Large free-floating thrombus in the iliac vein or IVC; * Following massive PE in which recurrent emboli may prove fatal; * During/after surgical or transcatheter embolectomy; * Filter placement in high-risk trauma and orthopedic patients: * High risk trauma or orthopedic patients who cannot receive anticoagulation because of increased bleeding risk, and have one or more of the following injury patterns (31, 40): 1. Severe closed head injury (GCS \< 8); 2. Incomplete spinal cord injury with para or quadriplegia; 3. Complex pelvic fractures with associated long-bone fractures; 4. Multiple long bone fractures. * Patients undergoing long-term immobilization (e.g., ICU or Surgical oncology) Exclusion Criteria: * All patients under 18 years of age. * All patients undergoing emergency procedures. * All patients with abnormal IVC anatomy or pathology of the IVC such as thrombosis or tumor which prevent safe filter implantation. * All patients with an IVC diameter which precludes oversizing of the filter platform. * All patients with active infection / bacteremia. * All patients with sensitivity to contrast media. * Uncorrectable severe coagulopathy (e.g., patients with liver or multisystem failure).