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The SafeFlo® Vena Cava Filter set is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy in thromboembolic diseases, - 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.

The SafeFlo Filter is a Nitinol filter designed for simple, stable and safe implantation in the inferior vena cava to allow blood flow towards the heart while preventing the passage of emboli into the pulmonary arteries. The SafeFlo Filter set comprises the vena cava filter unit and a delivery system kit, provided in separate packages. The SafeFlo Filter is inserted through a 6F (ID) delivery system. The filter is divided into two functional parts, the Double Ring Platform and the Filter Element. The Double Ring Platform is a fixator, which anchors itself in the vessel wall by over-sizing of the rings with respect to the circular diameter of the vessel. The Double Ring Platform has been designed to exit the delivery sheath and rotate through 90° to be positioned perpendicular to the vessel wall. This method of fixation does not utilize individual hooks and therefore vessel trauma is minimized and repositioning is possible. The Filter Element is the functional unit of the filter; it is shaped from the continuation of the wires of the Double Ring Platform and is thereby supported securely within the bloodstream. The Filter Element's unique double strand structure forms an Outer Support Ring and an inner 5-leafed filtration configuration whose design allows relatively unhindered blood flow and traps clinically significant migrating emboli. The Filter Element's size (diameter) is designed to be up to 3mm smaller than the diameter of the IVC.