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The Option (TM) ELITE Vena Cava Filter System is intended for the prevention of recurrent pulmonary embolion (PE) via placement in the vena cava in the following conditions: - · Pulmonary thromboembolism when anticoagulant therapy is contraindicated; - · Failure of anticoagulant therapy in thromboembolic diseases; - · Emergency treatment following massive pulmonary embolism when anticipated beaeffits of conventional therapy are realised; - · Chronic, recurrent pulmonary embolism when anticoagulation therapy has failed or is contraindicated The filter may be retrieved according to the instructions supplied in section entitled "Optional " in patients who no longer require a filter. Retrieval of the fitter can be performed only by jugular approach.

The Option™ ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via percutaneous delivery in the inferior vena cava (IVC). The self-centering Option™ ELITE Filter is laser cut from nickel - itanium alloy (Nitinol) tubing. The Option™ ELITE Filter consists of shape memory Nitinol struts emanating from a central location and is designed for optimal clot capture. Retention anchors (retention hooks) are located at the proximal or caudal portion of the filter. These anchors are intended for filter fixation to the vessel wall. The Option™ ELITE Filter is intended to be used in caval diameters up to 30mm. A retrieval hook is centrally located at the cranial extremity. The constrained Option™ ELITE Filter is flexible and expands to the internal diameter of the IVC upon deployment. The Option™ ELITE Filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent pulmonary embolism while maintaining caval patency through central filtration. The introduction kit is comprised of a filter housed in a filter cartridge, Catheter Sheath Introducer (5F ID), Angiographic Vessel Dilator with an open end, and a Pusher with deployment marker. The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter Sheath Introducer up to the deployment marker, and is then used to fi x the filter in place during uncovering. The location of the distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the vena cava. The Filter Cartridge houses the Option™ ELITE Filter. The body of the Cartridge has text and colored arrows printed on it that identify assembly orientation, femoral is printed in green and jugular is printed in blue. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

The Rex Medical Cleaner™ Rotational Thrombectomy System is designed for mechanical declotting of synthetic dialysis access grafts.

The Rex Medical Cleaner™ Rotational Thrombectomy System is percutaneous mechanical thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis access grafts. The device is used in exactly the same manner as the predicate devices.

The Short Introducer Sheath is used to facilitate placing a catheter through the skin into a graft. The dilator is an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling system.

The Rex Medical Short Introducer Sheath, offered in both 6F and 7F sizes, is a vascular access device consisting of a central lumen, angled side arm extension. and a hemostasis valve. The device is used under identical indications for use as the predicate device, as well other substantially equivalent 510(K) cleared devices.