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The Swan-Ganz pacing-TD catheters are indicated for use for temporary, atrial, ventricular, or A-V sequential cardiac pacing of adult surgical and/or critically ill patients. This includes, but is not limited to, patients with arrythmias, acute myocardial infarction, cardiac surgery, and coronary angiography. In addition, these catheters are indicated for use in hemodynamic monitoring of patients experiencing medical conditions such as, but not limited to, post-major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, stroke, and cardiac disease including heart failure. The Swan-Ganz bipolar pacing catheters are indicated for use in surgical and/or critically ill cardiac patients who may benefit from temporary, transvenous right ventricular pacing. The Chandler transluminal V-pacing probe is a transluminal bipolar pacing probe, which must be used with a Swan-Ganz Paceport catheter is indicated for use in adult surgical and/or critically ill cardiac patients. This includes, but is not limited to, patients with arrhythmias, acute myocardial infarction, cardiac surgery and coronary angiography.

The Swan-Ganz Pacing Catheters and Pacing Probes are a series of specialized catheters and pacing probes, which are temporarily inserted into the central circulatory system vasculature to facilitate temporary atrial, ventricular, or A-V sequential pacing and to serve as diagnostic and/or therapeutic tools. The catheters may be used to overdrive suppression of arrhythmias and diagnosis of complex arrhythmias. The pacing catheters and probes may be used for ECG detection during placement but are not intended to be used for ECG monitoring.

The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.

The Swan-Ganz catheters are flow-directed pulmonary artery catheters used to monitor hemodynamic pressures. The Swan-Ganz thermodilution catheters provide diagnostic information to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.

Swan-Ganz catheters: The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure. Models 096F6, 096F6P, TS105F5, 132F5, 131F7, 131F7P 831F75, 831F75P, 834F75, and 834F75P are intended for adult and pediatric patients: The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of critically ill adult and pediatric patients ≥ 12 years of age including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure. FloTrac sensors: The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients. Models MHD6, MHD8, MHD65, and MHD85 are intended for adult and pediatric patients: The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac sensor is indicated for use in adult and pediatric patients ≥ 12 years of age. ClearSight finger cuffs: The Acumen IQ are indicated for patients over 18 years of age to non-invasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere Advanced Monitoring Platform. The ClearSight finger cuffs are indicated for adult and pediatric patients ≥ 12 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere Advanced Monitoring Platform. HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module: The HemoSphere advanced monitor when used with the HemoSphere Swan-Ganz module and Edwards Swan-Ganz catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population. HemoSphere Advanced Monitor with HemoSphere Pressure Cable (compatible with FloTrac sensors): The HemoSphere advanced monitor when used with the HemoSphere pressure cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, Acumen IQ sensor, and TruWave DPT indications for use statements for information on target patient populations specific to the sensor/transducer being used. The Edwards Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI™ feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI™ feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population. HemoSphere Advanced Monitor with ClearSight Module: The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for adult and pediatric patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters. Refer to the ClearSight finger cuff and Acumen IQ finger cuff indications for use statements for information on target patient population specific to the finger cuff being used. The Edwards Acumen Hypotension Prediction Index (HPI) feature provides the clinician with physiological insight into patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

Swan-Ganz Catheters: The Swan-Ganz catheters are flow-directed pulmonary artery catheters used to monitor hemodynamic pressures. The Swan-Ganz thermodilution catheters provide diagnostic information to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. FloTrac Sensors: The FloTrac sensor is a sterile, single use kit that monitors pressures when attached to pressure monitoring catheters. When connected to a compatible monitor, the FloTrac sensor minimally-invasively measures cardiac output and key hemodynamic parameters, which assist the clinician in assessing the patient's physiologic status and support clinical decisions related to hemodynamic optimization. The disposable sterile cable, with a red-connector interfaces, exclusively with an Edwards cable that is specifically wired for the pressure monitor being used. The disposable sterile cable, with a green-connector interfaces, exclusively with the Edwards cables for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware. The FloTrac sensor has a straight, flow-through design across the pressure sensors with an integral flush device. ClearSight finger cuffs: The ClearSight finger cuffs, when used with an appropriate Edwards monitoring system, provide continuous, noninvasive hemodynamic monitoring. The ClearSight finger cuffs utilize the volume-clamp method to measure blood pressure with an inflatable bladder wrapped around the middle phalanx of the finger. HemoSphere Advanced Monitor Platform: The HemoSphere Advanced Monitoring Platform was designed to simplify the customer experience by providing one platform with modular solutions for their hemodynamic monitoring needs. The user can choose from the available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides the customer with the choice of purchasing and/or using specific monitoring applications based on their needs. Users are not required to have all of the modules installed at the same time for the platform to function.

The primary indications for the Swan-Ganz IQ Pulmonary Arterial catheter includes: - Acute heart failure - Severe hypovolemia - Complex circulatory situations - Medical emergencies - Adult respiratory distress syndrome - Gram negative sepsis - Drug intoxication - Acute renal failure - Hemorrhagic pancreatitis - Intra and post-operative management of high risk patients - History of pulmonary or cardiac disease - Fluid shifts (e.g., extensive intra-abdominal operations) - Management of high-risk obstetrical patients - Diagnosed cardiac disease - Toxemia - Premature separation of placenta - Cardiac output determinations - Differential diagnosis of mitral regurgitation and ventricular septal rupture - Diagnosis of cardiac tamponade Secondary indications include the following: - Blood Sampling - Infusion of saline and dextrose solutions Intended Use- Swan-Ganz IQ catheter: The Swan-Ganz IQ catheter (model AIQSGF8) is for use in patients who require hemodynamic monitoring. It is intended to be used in combination with clinical pressure monitoring, equipment to measure right heart and pulmonary artery pressures, and with a compatible cardiac output computer to measure intermittent cardiac output. Model AIOSGF8 also measures mixed venous oxygen saturation.

The Edwards Swan-Ganz catheters are used to monitor the hemodynamic status of critically ill and injured patients. The existing catheters give clinicians the ability to measure right heart pressures, pulmonary artery occlusion pressure ("wedge"), sample mixed venous blood from the pulmonary artery, as well as measure cardiac output through thermodilution when used with a bedside physiologic monitor and pressure transducers. The Edwards Swan-Ganz product line is comprised of Standard (Base) and Advanced Technology monitoring catheters. The standard Swan-Ganz catheter measures: right heart pressures, thermodilution cardiac output (room temperature and chilled) and provides a mechanism for pulmonary artery blood sampling for laboratory analysis. The subject Swan-Ganz IO catheter combines from the existing Advanced catheter design (model 777F8) and the Paceport catheter design (model 780F75M). Using the 777F8 model as the base design, the new catheter modifies the design to remove the thermal filament functionality and replaces it with an additional port which will allow for pressure monitoring at the right ventricular level. The RV port is utilized just like the Swan-Ganz Paceport Oximetry catheter model 780F75M. Just like the existing advanced catheters, the Swan-Ganz IQ catheter provides the same functionality as the standard and Advanced Technology Swan-Ganz catheters by providing the ability to continuously monitor the patient's balance between oxygen delivery and consumption as well as the ability to help investigate the root cause of an imbalance through analysis of the components of stroke volume (preload, afterload, and contractility).

Swan-Ganz flow-directed monitoring catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Secondary indications are for sampling blood and infusing solutions. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. ControlCath thermodilution catheters and Torque Support Thermodilution catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. Swan-Ganz oximetry TD catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, continuous mixed venous oxygen saturation monitoring, and for infusing solutions. For 631NX55, the distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

The Swan-Ganz catheters are cardiovascular diagnostic catheters intended for use on critical care patients. Swan-Ganz catheters are used to monitor the hemodynamic status of critically ill and injured patients. The catheters give clinicians the ability to measure right heart pressures, pulmonary artery occlusion pressure ("wedge"), sample mixed venous blood from the pulmonary artery, as well as measure cardiac output through thermodilution when used with a bedside physiologic monitor. The subject Edwards Swan-Ganz product line is comprised of Base and Advanced Technology monitoring catheters. The Base Swan-Ganz catheter measures: right heart pressures, thermodilution cardiac output (room temperature and chilled) and provides a mechanism for pulmonary artery blood sampling for laboratory analysis. In addition to providing most of the same functionality as the Base models, the Advanced Swan-Ganz catheters provide the ability to continuously monitor the patient's mixed venous oxygen saturation, the balance between oxygen delivery and consumption, when used with an Edwards Lifesciences oximetry monitor or compatible bedside module system. It also monitors cardiac output with a compatible cardiac output computer.

Swan-Ganz flow-directed monitoring catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Secondary indications are for sampling blood and infusing solutions. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. The Swan-Ganz thermodilution Paceport catheters (Model 931F75) are used for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The Paceport catheter (Model 931F75) may also be used for standby temporary ventricular pacing. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. The Swan-Ganz thermodilution A-V Paceport catheter (Model 991F8) is indicated for the assessment of a patient's hemodynamic condition through simultaneous right atrial, right ventricular, and pulmonary artery or wedge pressure monitoring, cardiac output determination, and for infusing solutions. The A-V Paceport catheter (Model 991F8) is also indicated for standby temporary ventricular, atrial, or A-V sequential pacing using the Model D98100 Chandler Transluminal V-pacing probe and/or Model D98500 A-pacing probe. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. ControlCath thermodilution catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. Torque Support Thermodilution catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. The primary indications for the Swan-Ganz CCO thermodilution catheters include: Acute heart failure, Severe hypovolemia, Complex circulatory situations, Medical emergencies, Adult respiratory distress syndrome, Gram negative sepsis, Drug intoxication, Acute renal failure, Hemorrhagic pancreatitis, Intra and post-operative management of high risk patients, History of pulmonary or cardiac disease, Fluid shifts (e.g., extensive intra-abdominal operations), Management of high-risk obstetrical patients, Diagnosed cardiac disease, Toxemia, Premature separation of placenta, Cardiac output determinations, Differential diagnosis of mitral regurgitation and ventricular septal rupture, Diagnosis of cardiac tamponade. Models with CEDV capabilities are also indicated for volumetric determinations. Secondary indications include the following: Blood Sampling, Infusion of saline and dextrose solutions. The primary indications for the CCOmbo EDV TD catheters include: Acute heart failure, Severe hypovolemia, Complex circulatory situations, Medical emergencies, Adult respiratory distress syndrome, Gram negative sepsis, Multi system organ failure, Drug intoxication, Acute renal failure, Hemorrhagic pancreatitis, Intra and post-operative management of high risk patients, History of pulmonary or cardiac disease, Fluid shifts (e.g., extensive intra-abdominal operations), Management of high-risk obstetrical patients, Diagnosed cardiac disease, Toxemia, Premature separation of placenta, Cardiac output determinations, Volumetric determinations, Differential diagnosis of mitral regurgitation and ventricular septal rupture, Diagnosis of cardiac tamponade. Secondary indications include the following: Blood Sampling, Infusion of saline and dextrose solutions. Swan-Ganz oximetry TD catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, continuous mixed venous oxygen saturation monitoring, and for infusing solutions. The oximetry Paceport catheters (model 780F75M) are also indicated for standby temporary ventricular pacing using the model D98100 Chandler transluminal V-pacing probe. For all models, the distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. The REF/Ox catheters (Models D754F75 and 759F75) are indicated for continuous mixed venous oxygen saturation in addition to the prior listed indications. For Models D754F75 and 759F75, the distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

The Swan-Ganz catheters are well known pulmonary artery catheters intended for use on critical care patients. A Swan-Ganz Catheter includes an inflatable balloon at the tip, which facilitates its placement into the pulmonary artery through the flow of blood. The catheters can be grouped together based on functionality. The Swan-Ganz catheters can be used with compatible cardiac output patient monitors and/or with oximetry modules (depending on the model number) to transmit signals for hemodynamic pressure monitoring, cardiac output measurements, and/or oximetry measurements. The Swan-Ganz catheters are to be used with the Edwards and/or Edwards' compatible patient monitors, such as the Vigilance II.

The Percu-Pro™ Messenger Balloon Catheter is intended to facilitate the placement of interventional devices during diagnostic and interventional cardiovascular procedures. The device is not intended for coronary or neurovascular use.

The Cardiosolutions Percu-Pro™ Messenger Balloon Catheter is a 5Fr catheter with a bifurcated proximal hub. The catheter shaft and connection ends are made from Pebax and the distal tip balloon is made from latex.

Hospira Advanced Sensor Catheters: Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output. Oxyhemoglobin Saturation, and Venous Blood Sampling. A secondary indication is for the therapeutic infusion of solutions. Hospira Critical Care Catheters; Indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients including the following : acute heart failure; differentiating ruptured ventricular septum form mitral regurgitation; diagnosis of tamponate; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifts (such as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of the placenta; cardiac output determination by thermodilution method; and blood sampling. Additional indication for Hospira Critical Care Pacing Lead Catheters: Indicated for temporary transluminal ventricular pacing using a temporary ventricular lead.

The Hospira Critical Care and Advanced Sensor Catheters have multi-lumens that incorporate some or all of the following components and features: a distal balloon for positioning the catheter tip via blood flow within the pulmonary artery, a heater coil for determining continuous cardiac output, a thermistor for monitoring core temperature and cardiac output, fiber optics for monitoring mixed venous oxygen saturation (SvQ2), and access ports for drug delivery or blood sampling. In addition, the Hospira Critical Care Pacing Lead Catheters include an access port for use with Transluminal Right Ventricular Pacing Leads. The catheters also incorporate insertion distance markings and are provided with a syringe for inflating the balloon.

The Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor systems intended use is for the assessment of a patients haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also all ws for sampling of venous blood.

The Continuous Cardiac Ouptut Pulmonary Artery Catheter, (truCATH), is a six lumen heparin coated, polyvinyl chloride (PVC) flow directed Pulmonary Artery Catheter. Once placed the proximal extensions of the catheter are attached to the second part of the system, the monitor. The Continous Cardiac Output Monitor, (truCCOM), is a microprocessor based computer which when interfaced with the truCATH, continuously calculates and displays cardiac output. The monitor calculates cardiac output based upon a thermodynamic principle of heat transfer using thermal power produced by the termal coil area on the Catheter. Alternatively the monitor can also be used by the clinician to measure cardiac output intermittently through using the injectate capabilities of the catheter.

The Occlusion Balloon Catheter, model Venos™, is intended for a temporary occlusion of coronary sinus during a venogram, or infusion of contrast media or drug, or for possible introduction of devices into the coronary venous system.

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