Denali Vena Cava Filter System - Femoral - Vena cava filter, optional

Intended purpose

The Denali™ Filter is indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations: • Pulmonary thromboembolism when anticoagulants are contraindicated • Failure of anticoagulant therapy for thromboembolic disease • Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced • Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated

Functional description

The Denali Vena Cava Filter System consists of an introducer sheath & dilator, and a preloaded filter in a storage tube with a pusher. The filter is a venous interruption device consists of 12 shape-memory laser-cut nickel-titanium appendages. These 12 appendages form 2 levels of filtration with the legs & the arms. The Filter is designed to act as a permanent filter but may be removed after implantation. The filter is delivered via the femoral approach.