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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).

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 of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also 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 below for a complete list of measured and derived parameters available for each patient population. HemoSphere Advanced Monitor with HemoSphere Oximetry Cable The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cathetry catheters is indicated for use in adult and pediativ critical care patients requiring of venous oxygen saturation (Sv02 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximeter 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 The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in 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 hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used. The Edwards Lifesciences 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 operating room (OR) patients receiving advanced hemodynamic monitoring. The Acumen 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 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 HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue Oximeter Module The noninvasive FORE-SIGHT ELITE tissue oximeter module is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the Sensors in individuals at risk for reduced-flow or no-flow ischemic states. The FORE-SIGHT ELITE tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor. When used with large sensorsis indicated for use on adults and transitional adolescents ≥40 kg. When used with Medium Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on pediatric subjects >3 kg. When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects < 8 kg and non-cerebral use on pediatric subjects <5kg. 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 ClearSight Module The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age 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 indications for information on target patient population specific to the finger cuff being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and five (5) optional external modules: the HemoSphere Swan-Ganz Module (K163381 Cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 Cleared, April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16, 2018), HemoSphere Tissue Oximetry Module (K190205 August 29, 2019), FORE-SIGHT ELITE Tissue Oximeter Module (K180003, May 10, 2018), and the subject HemoSphere ClearSight Module. The subject HemoSphere ClearSight module is a non-invasive subsystem module intended to continuously and noninvasively measure blood pressure and associated hemodynamic parameters. HemoSphere ClearSight module is intended to provide ClearSight functionality (Non-Invasive) previously cleared in EV1000 Clinical Platform NI (K160552 June 1, 2017) to the HemoSphere Advanced Monitoring Platform. It provides power, communications, air and an interface to connect with currently cleared and commercially available Edwards Lifesciences ClearSight System (K160552 June 1, 2016) which includes ClearSight finger cuffs (K160552 June 1, 2016 and K190130 June 21, 2019), Pressure Controller/Wrist Unit (K160552 June 1, 2016), Heart Reference Sensor (K182245 Nov 30, 2018), and the HemoSphere Advanced Monitor (K190205 August 29, 2019).