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The intended use of both Systems is to prevent embolisms from migrating to the pulmonary arteries.

The cleared SNF/SL and SNF Systems and the proposed models of the SNF/SL and SNF Systems are composed of a SN Filter and a delivery system. The SN Filter component is made of a nitinol alloy which has thermal shape memory properties. These properties allow the nitinol alloy wires to be formed into the shape of a filter. When cooled, the wires can be straightened to allow delivery through a small diameter catheter. The SN Filter resumes its original shape, a dome with six legs, when warmed to body temperature in the vena cava. The SN Filters are delivered via the Seldinger technique, using a 7 French I.D. angiographic introducer sheath and a preliminary venacavogram. The sheath is introduced into the vein and positioned in the vena cava. When the sheath is positioned in the vena cava, the dilator is removed and the delivery system for the SN Filter is attached to the sheath. The SN Filter is then advanced through the sheath using the pusher wire until the SN Filter is at the tip of the sheath in the vena cava. The pusher wire has a stainless steel pusher cup or pad on the distal end of the pusher wire. The pusher wire is held in position while the sheath is withdrawn. This action releases the SN Filter into the vena cava; the SN Filter expands to its original shape which secures it against the vena cava. The sheath is then removed. NMT intends to modify the gold radiopaque marker band from one which is deposited onto the introducer sheath to one which is mechanically swaged onto the introducer sheath.

The intended use of Nitinol Medical Technologies, Inc.'s ("NMT") Simon Nitinol Filter/Straight Line™ System ("SNF/SL System") is to prevent pulmonary embolisms from migrating to the pulmonary arteries.

The cleared SNF/SL System and the proposed models of the SNF/SL System are composed of a SN Filter and a delivery system. The SN Filter component is made of a nitinol alloy which has thermal shape memory properties. These properties allow the nitinol alloy wires to be formed into the shape of a filter. When placed in saline, the wires become soft and can be straightened to allow delivery through a small diameter catheter. The SN Filter reassumes its original shape, a dome with six legs, when warmed to body temperature in the vena cava. The SN Filters are delivered via the Seldinger technique, using a 7 French I.D. angiographic introducer sheath ("sheath") and a preliminary venacavogram. The sheath is introduced into the vein and positioned in the vena cava. When the sheath is positioned in the vena cava, the dilator is removed and the delivery system for the SN Filter is attached to the sheath. The SN Filter is then advanced through the sheath using the pusher wire until the SN Filter is at the tip of the sheath in the vena cava. The pusher wire has a stainless steel pusher cup or pad on the distal end of the pusher wire. The pusher wire is held in position while the sheath is withdrawn. This action releases the SN Filter into the vena cava: the SN Filter expands to its original shape which secures it against the vena cava. The sheath is then removed.

The intended use of Nitinol Medical Technologies, Inc.'s ("NMT") Simon Nitinol Filter™ System ("SNF System") is to prevent pulmonary embolisms from migrating to the pulmonary arteries.

The cleared SNF System and the proposed models of the SNF System are composed of a SN Filter and a delivery system. The SN Filter component is made of a nitinol alloy which has thermal shape memory properties. These properties allow the nitinol alloy wires to be formed into the shape of a filter. When placed in saline, the wires become soft and can be straightened to allow delivery through a small diameter catheter. The SN Filter resumes its original shape, a dome with six legs, when warmed to body temperature in the vena cava. The SN Filters are delivered via the Seldinger technique, using a 7 French I.D. angiographic introducer sheath and a preliminary venacavogram. The sheath is introduced into the vein and positioned in the vena cava. When the sheath is positioned in the vena cava, the dilator is removed and the delivery system for the SN Filter is attached to the sheath. The SN Filter is then advanced through the sheath using the pusher wire until the SN Filter is at the tip of the sheath in the vena cava. The pusher wire has a stainless steel pusher cup or pad on the distal end of the pusher wire. The pusher wire is held in position while the sheath is withdrawn. This action releases the SN Filter into the vena cava: the SN Filter expands to its original shape which secures it against the vena cava. The sheath is then removed. NMT intends to make two types of modifications to the cleared SNF System. First, NMT intends to market models of the SNF System with zero, one, and two gold, radiopaque marker bands. Second, NMT intends to expand the device's delivery methods to include subclavian delivery using the same delivery system as used for jugular delivery.