A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System

A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System

To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter

Inclusion Criteria:

• Pulmonary thrombo-embolism with contraindication to anticoagulation.
• Failure of anticoagulant therapy in thrombo-embolic diseases.
• Prevention of pulmonary embolism in patients with a recent history ( <3 months) of DVT/ PE who need to undergo urgent surgery at high risk of DVT/PE with temporary contra-indication to the use of therapeutic doses of anticoagulants.
• Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and
• Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated

Exclusion Criteria:

• The filter should not be implanted in patients with :

  • A vena cava which has a diameter < 14 mm or > 28 mm (due to the risk of device migration)
  • Risk of septic embolism
  • Known allergy to the materials contained in the kit, allergy to contrast media.
  • Severely disabled patients whose life-expectancy, up to 6 months, appears limited according to the investigator's opinion.

In addition, exclusion criteria are also extended to :

• Patients who cannot be regularly followed up by the participating center
• Subject who already has an implanted vena cava filter
• Subject who has a duplicated IVC
• Subject who has a contrast allergy to both iodinated contrast and non-iodinated contrast material
• Subject unable to understand information about participation in the study due to a language barrier, intellectual deficiency, psychiatric problems…
• Subject who has a renal failure (creatinemia clearance < 30ml/min)