Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3 ("RETRIEVE 3")

Inclusion criteria

• Patient has a permanent or temporary risk of Pulmonary Embolism.
• Patient must provide informed consent At least one of the following conditions -
• Proven PE
• Recurrent PE despite adequate
• Contraindication to anticoagulation
• Inability to achieve/maintain therapeutic anticoagulation
• Iliocaval DVT
• Large, free-floating proximal DVT
• Massive PE treated with thrombolysis/thrombectomy
• Chronic PE treated with thrombectomy
• Protection during thrombolysis for iliocaval DVT
• PE with limited cardiopulmonary reserve
• Poor compliance with anticoagulation medication
• High risk of injury worsening on anticoagulation
• Multi-trauma patient with high risk of PE
• Surgical patients at high risk of PE
• Medical condition with high risk of PE Patients with a documented vena cava diameter of 17-28mm Patient has IVC anatomy suitable for infra-renal placement Patient is willing to be available for the appropriate follow up

Exclusion criteria

• Age <18 years old
• Patient has any one of the following conditions:

• Renal vein thrombosis
• IVC thrombosis extending to the renal veins
• Duplicate IVC
• Gonadal vein thrombosis
• Requires supra-renal placement
• Vena cava diameter of 17-28mm
• Uncontrolled infectious disease
• Risk of aseptic PE
• Uncontrolled coagulopathy
• Existing inferior vena cava filter implant
• Life expectancy less than 6 months
• Pregnant or planning a pregnancy in the next 6 months
• Condition that inhibits radiographic visualization of the IVC
• Known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol
• Known hypersensitivity to contract which cannot be pretreated
• Access vessels preclude same insertion of delivery system
• Participation in another drug or device trial
• Unable or unwilling to cooperate with study procedures or required follow-up visits