Crux Biomedical Vena Cava Filter Study - United States

Inclusion criteria

• Patient has a permanent or temporary risk of Pulmonary Embolism
• Patient or legal guardian must provide written informed consent
• At least one of the following conditions

• Proven PE
• Recurrent PE despite adequate anticoagulation
• 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
• Procetion during thrombolysis for iliocaval DVT
• PE with limited cardiopulmonary reserve
• Poor compliance with anticoagulation medication
• High risk of injury worsend by anticoagulation
• Multi-trauma patient with high risk of PE
• Surgical patients at high risk of PE
• Medical condition with high risk of PE
• Patient has documented vena cava diameter of 17-28mm
• Patient has IVC anatomy suitable for infra-renal placement
• Patient 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 te renal veins
• Duplicate IVC
• Gonadal vein thrombosis
• Requires supra-renal placement
• 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 safe insertion of delivery system
• Participation in another drug or device trial
• Unable or unwilling to cooperate with study procedures or required follow-up visits