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The Solex Catheter Model SL2593, connected to an Alsius External Thermal Regulation System, is indicated for use: - in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and - to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care.

The SOLEX catheter is a multi lumen intravascular catheter. The catheter has two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. When the heat exchange feature of the catheter is in use, heated/chilled saline is pumped through the heat exchange lumen, expanding the diameter of the distal portion of the catheter to a nominal 12.2 mm where the heating/cooling membranes interface with the patient's circulating blood. The inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The chilled saline is not infused into the patient. Additional lumens of the Alsius Solex Catheter Model SL2593 consist of a standard guide wire lumen that can be used as a primary infusion lumen, and two additional infusion lumens within the shaft.

The THERMOGARD XP can be used with any of the Alsius Catheters. The indications for use are specific to the catheter. Please refer to the Indications for Use statement in the catheter specific Instructions for Use. The THERMOGARD XP/Alsius Catheter Thermal Regulation System, using either the Icy™ or Fortius™ model catheter, is indicated for use: - . In cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and - To induce, maintain and reverse mild hypothermia in neurosurgery patients in . surgery and recovery/intensive care. The Alsius THERMOGARD XP™ and Cool Line™ Catheter Thermal Requlation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

The THERMOGARD XP and Catheter Thermal Regulation System consists of the THERMOGARD XP, a disposable Start Up Kit used to interface between the cooling bath of the THERMOGARD XP and the intravascular Catheter. The THERMOGARD XP is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller primo. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient. The technical characteristics of the Catheter are identical to the predicate device.

The Quattro Catheter Model IC4593, connected to an Alsius Catheter Thermal Regulation System, is indicated for use: - in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and - to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care.

The QUATTRO catheters are multi lumen intravascular catheters in various sizes. In common across the models, the catheters have two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. When the heat exchange feature of the catheter is in use, heated/chilled saline is pumped through the heat exchange lumen, expanding the diameter of the distal portion of the catheter to a nominal 5mm or 8mm where the heating/cooling membranes interface with the patient's circulating blood.

The THERMOGARD can be used with any of the Alsius Catheters. The indications for use are specific to the catheter. Please refer to the Indications for Use statement in the catheter specific Instructions for Use. The THERMOGARD/Alsius Catheter Thermal Regulation System, using either the Icy™ or Fortius™ model catheter, is indicated for use: - In cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and - To induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care. The Alsius THERMOGARD™ and Cool Line™ Catheter Thermal Regulation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

The THERMOGARD and Catheter Thermal Regulation System consists of the THERMOGARD, a disposable Start Up Kit used to interface between the cooling bath of the THERMOGARD and the intravascular Catheter. The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient. The technical characteristics of the Catheter are identical to the predicate device with the exception of revisions to the software that controls the device. All models of Alsius Intravascular catheters are available for use with the THERMOGARD.

The COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the IcyTM or Fortius™ model catheter, is indicated for use: - . In cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and - . To induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care. The Alsius CoolGard® 3000 and Cool Line™ Catheter Thermal Regulation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

The CoolGard and Catheter Thermal Regulation System consists of the CoolGard™ 3000, a disposable Start Up Kit used in the CoolGard™ for interface with the cooling bath and patient catheter and the Intravascular Catheter. The Alsius CoolGard™ 3000 is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.

The Icy™ Catheter Model IC-3893A, connected to the COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, is indicated for use: - in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and - to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care.

The ICY™ catheters are multi lumen intravascular catheters in various sizes. In common across the models, the catheters have two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. When the heat exchange feature of the catheter is in use, heated/chilled saline is pumped through the heat exchange lumen, expanding the diameter of the distal portion of the catheter to a nominal 5mm or 8mm where the heating/cooling membranes interface with the patient's circulating blood. The inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The chilled saline is not infused into the patient. Additional lumens of the Alsius Icy™ Catheter Model IC-3893A consist of a standard guide wire lumen that can be used as a primary infusion lumen, and two additional infusion lumens within the shaft. The Icy™ Catheter Model IC-3893A is the same as the predicate device, the Icy™ Model IC-3585A except that it has two extra infusion lumens with a corresponding increase in shaft diameter. The heat exchange capability of the two catheters is the same.

The Alsius CoolGard® 3000 and Cool Line ™ Catheter Thermal Requlation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. The COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the lcy™ or Fortius™ model catheter, is indicated for use: - . in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and - . to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care.

The Alsius CoolGard And Catheter Thermal Regulation System.

The COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the Icy™ or Fortius™ model catheter, is indicated for use: - . in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and, - . to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care.

"he CoolGard and Catheter Thermal Regulation System consists of the CoolGard™ 3000, a disposable Start Up Kit used in the CoolGard™ for interface with the cooling bath and patient catheter and the Intravascular Catheter. The Alsius CoolGard™ 3000 is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient. The technical characteristics of the Catheter are essentially identical to those of widely used multi-lumen central venous catheters except for the dedicated closed loop fluid path through the heat exchange balloons. The Alsius Catheter materials are all biocompatible polyurethanes. Likewise, the CoolGard™ 3000 heater/cooler has the same technical features as the medical heater/cooler unit Identified as the predicate device. These common technical features include connections for recirculating coolant to and intravascular catheter and all or combinations of the following: redundant safety controls and alarms, patient monitoring and control and temperature displays for the clinician users. Two Models of Intravascular catheters are available for use with the CoolGard and Catheter Thermal Regulation System: - 1. ICY™ Catheter Kit Model IC-3585A - 2. Fortius™ Catheter Kit Model FR-5093A The ICY™ and Fortius™ catheters are multi lumen intravascular catheters in various sizes. Two of the catheter's lumens are used to circulate sterile saline to exchange heat with the central venous blood supply. When the heat exchange feature of the catheter is in use, heated/chilled saline is pumped through the heat exchange lumen, expanding the diameter of the distal portion of the catheter to a nominal 5mm where the heating/cooling membranes interface with the patient's circulating blood. The inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The chilled saline is not infused into the patient. Additional lumens of the Alsius Catheters consist of a standard guide wire lumen that can be used as a primary infusion lumen, and a second infusion lumen within the shaft, depending on the catheter model selected by the clinician. The Catheter blood contact surfaces are coated with Duraflo® Treatment, a heparin coating manufactured by Edwards Lifesciences Corporation. The Alsius Catheters are supplied sterile for single-use only. Principles of Operation: The CoolGard™ 3000 system automatically adjusts the temperature of the heater/chiller saline bath to achieve the patient target temperature that has previously een set by the attending physician. This is done via data from a temperature probe in the patient that interfaces with the temperature controller. This principle of operation is identical to currently marketed devices.

The Alsius CoolGard® 3000 and Cool Line ™ Catheter Thermal Regulation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

The CoolGard and Catheter Thermal Regulation System consists of the CoolGard™ 3000, a disposable Start Up Kit used in the CoolGard™ for interface with the cooling bath and patient catheter and the Intravascular Catheter. The Alsius CoolGard™ 3000 is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient. The technical characteristics of the Catheter are essentially identical to those of widely used multi-lumen central venous catheters except for the dedicated closed loop fluid path through the heat exchange balloons. The Alsius Catheter materials are all biocompatible polyurethanes. Likewise, the CoolGard™ 3000 heater/cooler has the same technical features as the medical heater/cooler unit Identified as the predicate device. These common technical features include connections for recirculating coolant to and intravascular catheter and all or combinations of the following: redundant safety controls and alarms, patient monitoring and control and temperature displays for the clinician users. Two Models of Intravascular catheters are available for use with the CoolGard and Catheter Thermal Regulation System: 1. Cool Line™ Catheter Kit Model CL 2085B (2 lumens) 2. Cool Line™ Catheter Kit Model CL 2295A (3 lumens) The Cool Line™ catheters are multi lumen intravascular catheters in two sizes. Two of the catheter's lumens are used to circulate sterile saline to exchange heat with the central venous blood supply. When the heat exchange feature of the catheter is in use, heated/chilled saline is pumped through the heat exchange lumen, expanding the diameter of the distal portion of the catheter to a nominal 5mm where the heating/cooling membranes interface with the patient's circulating blood. The inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The chilled saline is not infused into the patient. Additional lumens of the Alsius Catheters consist of a standard quide wire lumen that can be used as a primary infusion lumen, and a second or third infusion lumen within the shaft, depending on the catheter model selected by the clinician. The Catheter blood contact surfaces are coated with Duraflo® Treatment, a heparin coating manufactured by Edwards Lifesciences Corporation. The Alsius Catheters are supplied sterile for single-use only.