• Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization. [ Time Frame: 6 months follow-up ] [ Designated as safety issue: Yes ]
  

• The proportion of patients with successful deployment of the filter will be calculated and presented with a 95% exact confidence interval. [ Time Frame: 3 and 6 months follow-up ] [ Designated as safety issue: Yes ]
  

Device: SafeFlo IVC Filter
IVC 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).