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:

• Contraindication to anticoagulation
• Complication of anticoagulation
• Failure of anticoagulation

• Recurrent PE despite adequate anticoagulation therapy
• Inability to achieve adequate anticoagulation
• 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):

• Severe closed head injury (GCS < 8);
• Incomplete spinal cord injury with para or quadriplegia;
• Complex pelvic fractures with associated long-bone fractures;
• 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).