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The Sentry IVC Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in patients with a transient high risk of PE, 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.

The Sentry IVC Filter is a bioconvertible IVC filter intended for percutaneous implantation in the IVC and designed to provide protection against PE in patients at transient risk of PE. The Sentry IVC Filter is designed for use in inferior vena cavae with diameters between 16mm and 28mm and has a maximum deployed length of 57.7mm. It is preloaded in a Loading Tool that can be orientated for either left/right femoral vein or a right jugular vein approach and is delivered through a 7 French ID Introducer Sheath (max OD 9.75Fr). The Sentry IVC Filter consists of a cylindrical Nitinol frame and a Filter Cone formed by six Filter Arms held together in the center of the IVC by means of a bioabsorbable filament. The Filter Cone is designed to trap emboli and thereby reduce the risk of PE while maintaining caval patency after it has converted. The Sentry IVC Filter converts into a non-filtering configuration, the Filter Cone opens and the arms retract towards the IVC wall. This 510(k) is submitted to support a change to the design and manufacturing process for the Introducer Sheath of the Delivery System.

The Sentry IVC Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in patients with a transient high risk of PE, 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.

The Sentry IVC Filter is a bioconvertible IVC filter intended for percutaneous implantation in the IVC and designed to provide protection against PE in patients at transient risk of PE. The Sentry IVC Filter is designed for use in inferior vena cavae with diameters between 16mm and 28mm and has a maximum deployed length of 57.7mm. It is preloaded in a Loading Tool that can be orientated for either left/right femoral vein or a right jugular vein approach and is delivered through a 7 French ID Introducer Sheath (max OD 9.75Fr). The Sentry IVC Filter consists of a cylindrical Nitinol frame and a Filter Cone formed by 6 Filter Arms held together in the center of the IVC by means of a bioabsorbable filament. The Filter Cone is designed to trap emboli and thereby reduce the risk of PE while maintaining caval patency after it has converted. The Sentry IVC Filter converts into a non-filtering configuration, the Filter Cone opens and the arms retract towards the IVC wall.

The Sentry IVC Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in patients with a transient high risk of PE, 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.

The Sentry IVC Filter is a bioconvertible IVC filter intended for percutaneous implantation in the IVC and designed to provide protection against PE in patients at transient risk of PE. The Sentry IVC Filter is designed for use in inferior vena cavae with diameters between 16mm and 28mm and has a maximum deployed length of 57.7mm. It is preloaded in a Loading Tool that can be orientated for either left/right femoral vein or a right jugular vein approach and is delivered through a 7 French ID Introducer Sheath (max OD 9.75Fr). The Sentry IVC Filter consists of a cylindrical Nitinol frame and a Filter Cone formed by 6 Filter Arms held together in the center of the IVC by means of a bioabsorbable filament. The Filter Cone that is designed to trap emboli and thereby reduce the risk of PE while maintaining caval patency after it has converted. The Sentry IVC Filter converts into a non-filtering configuration, the Filter Cone opens and the arms retract towards the IVC wall.