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)