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Baxter Percutaneous Mechanical Thrombectomy (PMT) Device is indicated for removal of thrombus in synthetic dialysis access grafts.

The Baxter Percutaneous Mechanical Thrombectomy (PMT) Device consists of a 6-French catheter terminating at a stainless steel housing in which a small diameter helical screw is attached to a drive shaft. A battery-operated motor rotates a flexible drive shaft connected to the helical screw at approximately 3,100 rpm. A central lumen within the device is provided for guidewire placement or infusion of fluids.

Single Lumen Introducers: The Baxter Healthcare Single Lumen Hemostasis Valve Introducers are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). Multiple Lumen Access Products: The Baxter Healthcare Multiple Lumen Access Products are indicated for use in patients requiring access of the venous system, to facilitate catheter insertion (e.g., pulmonary artery or infusion catheter) and central venous pressure monitoring.

The Baxter Hemostasis Valve Introducers are used to access the venous system and to facilitate catheter insertion. The introducers are composed of a housing body to which a sheath is attached distally and a side port/extension tube is connected proximally. A valve is located in the housing body to provide a seal around a catheter when inserted through the Introducer and to prevent backflow when no catheter is present. A dilator is provided with the Introducer to ease insertion of the device into the vessel. The Baxter Hemostasis Valve Introducers are provided with and without AMC Thromboshield™ which is used on Baxter's catheters and introducer products. The device will be packaged in a tray sealed with a tyvek lid and sterilized using 100% ethylene oxide.

The intended uses of Baxter's Annuloplasty ring products with Duraflo Treatment are intended for use in patients to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines and prevent further dilatation of the annulus.

1. The Carpentier-Edwards Classic™ Ring with Duraflo® Treatment (Models 4425 and 4525) is constructed of titanium alloy and has a sewing ring margin that consists of a layer of siloxane polymer rubber covered with a polyester knit fabric. The mitral ring. Model 4425, conforms to the configuration of a normal mitral orifice. It is kidney-shaped with one long curved segment corresponding to the posterior leaflet. The ring is open in the rectilinear portion corresponding to the anterior leaflet and has transverse colored threads indicating the anterior and posterior commissures. The oval tricuspid ring, Model 4525, conforms to the configuration of a normal tricuspid orifice. The ring has one rectilinear segment corresponding to the septal leaflet and one long curved segment corresponding to the anterior and posterior leaflets. The ring is open at the anteroseptal commissure. Transverse colored threads indicate the site of the anteroposterior and posteroseptal commissures. 2. The Carpentier-Edwards Physio® Annuloplasty Ring with Duraflo® Treatment, Model 4450, is constructed of Elgiloy® bands separated by polyester film strips and has a sewing ring margin that consists of a layer of siloxane polymer tubing covered with a woven polyester cloth. 3. The Cosgrove-Edwards® Annuloplasty System with Duraflo® Treatment, Model 4600, is composed of a silicone rubber strip compounded with barium sulfate to improve radiographic visualization. This silicone rubber strip is covered with woven polyester velour cloth wrapped around the silicone and sewn together with a single seam using polyester thread.

The Fogarty® Valvulotome is intended to be used in the disruption of venous valves. The Fogarty® Valvulotome is indicated for use in veins during in situ or autologous bypass graft procedures.

The modified Fogarty® Valvulotome, like the predicate device, consists of a flexible shaft with a cutting blade at the distal tip and a handle at the proximal end. The mode of operation for both devices is the same. The device is inserted into the vessel in an antegrade direction until the blade is located above the cusp of a venous valve. The location of the valve is visualized via an angioscope or is directly visualized through the vein wall in an open procedure. The blade is withdrawn retrograde through the cusp, thereby rendering it incompetent. After the blade disrupts one cusp, it is then rotated 180° to disrupt the adjoining cusp segment. The Fogarty® Valvulotome, like the predicate device, contains an irrigation lumen that provides irrigation/fluid flow during the valvulotomy procedure. The modified device is available in one size that accommodates various vessel sizes and a usable length of 81 cm. A modification to the Fogarty® Valvulotome was implemented that enhanced the strength of the attachment of the blade holder to the stop. The blade is on the modified Fogarty® Valvulotome is retractable whereas the blade on the predicate device was not. The size and shape of the blade have been changed to accommodate retractability. The material used for the shaft and handle have been changed; the modified materials have been determined to be biocompatible. The handle now includes a control button for extension and retraction of the blade and guidewire.

The Intramed SBO System is intended for the intravascular delivery and placement of occlusion coils into tributaries during in situ saphenous vein bypass graft procedures. The angioscope within the Introducer Catheter is intended to be used for vessel visualization, specifically to visualize the lumen of the saphenous vein during the in situ procedures.

The Intramed SBO System, like the CRI Occlusion System, was developed for the intravascular delivery and placement of occlusion coils into tributaries during in situ saphenous vein bypass graft procedures. The system includes (1) a Coil Delivery Catheter, which is preloaded with an occlusion coil, and (2) an Introducer Catheter, which is used to visualize the side branches and mechanically direct the Coil Delivery Catheter into the side branch for occlusion. The Coil Delivery Catheter consists of a flexible catheter shaft with an occlusion coil positioned in the distal portion of the catheter lumen. A guide wire is contained within the inner shaft immediately proximal to the occlusion coil. At the proximal end of the catheter, this guide wire connects to a plunger mechanism. When the plunger is depressed. the quide wire pushes the coil out of the catheter and into the side branch for occlusion. The occlusion coil provided with the Intramed SBO System is purchased from Cook Incorporated. This product is a preamendment device that has been commercially distributed for vessel occlusion/embolizations. The use of this coil in the Intramed SBO System is within the intended use of the occlusion coils as marketed by Cook Incorporated. The Introducer Catheter has a composite shaft with two lumens. One lumen contains a miniature diameter angioscope with self-contained optics for visualization during the procedure. The other lumen is used to pass the Coil Delivery Catheter to the site of the side branch to be occluded. The catheter has an actuator handle to advance or retract the angioscope by a small amount to provide visualization of the vessel when the angioscope is in the extended position and visualization of the tributary when in the retracted position. The proximal end of the catheter consists of a coil catheter receiver as well as an eyepiece and light source connector for the angioscope.