Search Results

Indications for Use: This device is intended for use in patients who are morbidly obese and have failed to lose weight with diet and exercise.

{{deviceDescription}}

The Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.

The Edwards eSheath Optima introducer set consists of a sheath, vessel dilator, introducer, and insheath dilator. The Edwards Optima introducer set is available with inner sheath diameter of 14 French (model 14000ES14). The Edwards eSheath Optima introducer set is used to facilitate introduction of the Edwards transcatheter heart valve systems into the vasculature. The sheath shaft is composed of two layers; as devices are passed through the sheath, the inner member expands by sliding against itself while the outer iacket expands by stretching radially. temporarily expanding the shaft diameter. A radiopaque marker on the distal end indicates the location of the sheath tip in the body and a hydrophilic coating on the sheath tubing exterior facilitates introduction into the vessel. The sheath tubing mates with a housing, which holds three seals to provide hemostasis, and an extension tube with stopcock for flushing. The vessel dilator is used to dilate the vessel prior to sheath insertion. The introducer is inserted into the sheath hub and locked prior to insertion into the body over a guidewire. The in-sheath dilator is used to expand the sheath during device use at the physician's discretion. The introducer, vessel dilator, and in-sheath dilator are radiopaque to improve fluoroscopic visibility intra-procedure. The loader (included in the Edwards delivery system) features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.

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. The FloTrac Jr 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 Jr sensor is indicated for use in pediatric patients ≥ 12 years of age. The Acumen IQ 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. The VolumeView 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, Acumen IQ, and VolumeView sensors are constructed from two disposable pressure transducers that convert a physiological signal (or mechanical pressure) to an electrical signal that is transmitted through the cable to the patient monitor. The sensors have a straight, flow-through design in which fluid is passed directly across the pressure sensor. The sensors are comprised of a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A polycarbonate housing with an integral stopcock at one end, and an integral flush device at the other end, encloses the sensors.

HemoSphere Alta™ Advanced Monitor with Swan-Ganz Technology The HemoSphere Alta monitor when used with the HemoSphere Alta Swan-Ganz patient cable and Edwards Swan-Ganz catheters is indicated for use in adult and petical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed in a hospital environment. Refer to the Edwards Swan-Ganz Ir catheter indications for use statement for information on target patient population specific to the catheter being used. The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions. When used in combination with a Swan-Ganz catheter connected to a pressure transducer, the Edwards Lifesciences Smart Wedge algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressurement. The Smart Wedge algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring. The Smart Wedge algorithm 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 Smart Wedge algorithm parameters. HemoSphere Alta Advanced Monitor with HemoSphere Oximetry Cable The HemoSphere Alta monitor when used with the HemoSphere oximetry cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used. HemoSphere Alta Advanced Monitor with HemoSphere Pressure Cable or HemoSphere Alta Monitor Pressure Cable The HemoSphere Alta monitor when used with the HemoSphere Pressure Cable or HemoSphere Alta monitor Pressure cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac 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, FloTrac Jr, 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 software feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events 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 Hypotension Prediction Index (HPI) parameter. When used in combination with the Swan-Ganz technology connected to a compatible Swan-Ganz catheter, the Edward Lifesciences Right Ventricular Pressure (RVP) algorithm provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVP algorithm is indicated for critically ill patients over 18 years of age receiving advanced hemodynamic monitoring in the operating room (OR) and intensive care unit (ICU). The RVP algorithm 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 Right Ventricular Pressure (RVP) parameters. When used in combination with the HemoSphere Pressure Cable connected to a compatible Swan-Ganz catheter, the Right Ventricular Cardiac Output (RVCO) feature provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVCO algorithm is intended for use in surgical patients over 18 years of age that require advanced hemodynamic monitoring. The Right Ventricular Cardiac a continuous cardiac output and derived parameters. The Cerebral Adaptive Index (CAI) Algorithm is an informational index to help assess the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere pressure cable or HemoSphere Alta Pressure Cable and StO2 is acquired by the ForeSight oximeter cable. CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Adaptive Index (CAI) Algorithm. HemoSphere Alta Advanced Monitor with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor The Acumen assisted fluid management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the assisted fluid management suggestions. Acumen IQ Fluid Meter The Acumen IQ fluid meter is a sterile single use device that is intended to be used with the HemoSphere Alta AFM cable and AFM software feature to inform the user of the rate of flow. The device is intended to be used by qualified personnel or clinicians in a clinical setting for up to 24 hours. HemoSphere Alta Advanced Monitor with ForeSight Oximeter Cable The non-invasive ForeSight oximeter cable 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 ForeSight oximeter cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight oximeter cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere Alta monitor. • When used with large sensors, the ForeSight Oximeter Cable is indicated for use on adults and transitional adolescents ≥40 kg. · When used with Medium Sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects ≥3 kg. · When used with Small Sensors, the ForeSight Oximeter Cable is indicated for cerebral use on pediatric subjects < 8 kg and non-cerebral use on pediatric subjects <5kg. The Edwards Algorithm for Measurement of Blood Hemoglobin is indicated for continuously monitoring changes to hemoglobin concentration in the circulating blood of adults and transitional adolescents ≥ 40 kg receiving advanced hemodynamic monitoring using HemoSphere ForeSight Oximeter Cable and ForeSight IQ Sensors in cerebral locations. HemoSphere Alta Advanced Monitor with ClearSight Technology The HemoSphere Alta Monitor when used with the HemoSphere ClearSight technology, pressure controller and a compatible Edwards finger cuff are indicated for Adult and Pediatric patients 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 Alta monitor and compatible Edwards' finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters. The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acure is intended for use in surgical patients 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 Hypotension Prediction Index (HPI) parameter.

The HemoSphere Alta Advanced Monitoring Platform is Edwards' next-generation platform that provides a means to interact with and visualize hemodynamic and volumetric data on a screen. It incorporates a comprehensive view of patient hemodynamic parameters with an intuitive and easy user interface. The HemoSphere Alta Advanced Monitoring Platform is designed to provide monitoring of cardiac flow with various core technologies coupled with other technologies-based features such as Algorithms and Interactions. It integrates Edwards existing Critical Care technologies into a unified platform. The Right Ventricular Cardiac Output (RVCO) feature is a machinelearning algorithm that calculates and displays continuous cardiac output (CORV) from the right ventricle using as inputs the right ventricular pressure waveform and derived right ventricular pressure parameters such as SYSRVF, DIARVP, MRVP, RVEDP, PRRV and Max RV dP/dt from the existing Right Ventricular Pressure (RVP) algorithm and if available, intermittent cardiac output (iCO).

Cerebral Autoregulation Index (CAI) Algorithm is an informational index intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere pressure cable and StO2 is acquired by the ForeSight oximeter cable. CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Autoregulation Index (CAI) Algorithm.

The Cerebral Adaptive Index (CAI) Algorithm is being renamed to Cerebral Autoregulation Index (CAI) Algorithm. The originally cleared Cerebral Adaptive Index is in effect an index of cerebral autoregulation, and the renaming results in a labeling change. The evidence to support the proposed labeling change for the Cerebral Autoregulation Index algorithm demonstrates the capability of CAI to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired, as expressed by the level of coherence or lack thereof between MAP (as a surrogate of cerebral perfusion pressure) and cerebral StO2 (as a surrogate of cerebral blood flow) of the patient. The Cerebral Autoregulation Index (CAI) Algorithm is a derived parameter that quantifies the dynamic relationship between two existing hemodynamic parameters, Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in the cerebral tissue. CAI is intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of coherence between MAP and cerebral StO2. The output will be represented as an index value in a trend plot. MAP is acquired from the HemoSphere Pressure Cable (initially cleared in K180881 on November 16, 2018). StO2 used for computing CAI is acquired from the ForeSight Oximeter Cable (cleared in K201446 on October 1, 2020). CAI will be continuously displayed at 20-second rate. The parameter will not have any alarm ranges and will be represented as a number with a range between 0 to 100. A high CAI value (CAI ≥45) means that MAP and StO2 have a greater coherence and informs the clinician that alterations in MAP may result in concomitant changes in cerebral oxygen saturation because cerebral autoregulation is likely impaired. Whereas a low CAI value (CAI < 45) means there is lesser coherence between the two parameters, and therefore alterations in MAP may not result in concomitant changes in cerebral oxygen saturation because cerebral autoregulation is likely intact.

The Fogarty thru-lumen embolectomy catheter is indicated for adults requiring the removal of fresh, soft emboli and thrombi from vessels in the arteries of the peripheral vasculature. Additionally, it may also be used for temporary occlusion of blood vessels, infusion of fluids, and blood sampling in general surgical procedures.

The Fogarty Thru-Lumen Embolectomy Catheter is a double lumen catheter with a latex balloon at the distal end. One lumen is used for balloon inflation and is accessed through the gate valve at the proximal end. The thru-lumen is used for infusion of fluids, sampling of blood or guidewire passage through the distal tip. A removable stainless steel stylet(s) is provided.

The Edwards Lifesciences Acumen Assisted Fluid Management (AFM) Software Feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM Software Feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM Software Feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions.

The Acumen AFM Software Feature (core AFM algorithm + AFM Graphical User Interface) was originally granted in De Novo, DEN190029, on November 13, 2020, to inform clinicians about a patient's fluid responsiveness. The performance of the AFM Software Feature in predicting a patient's fluid responsiveness is measured using response rate and is calculated by reporting the percentage of followed AFM recommendations ("Fluid Bolus Suggested" and "Test Bolus Suggested" prompts) that have the desired change in stroke volume (SV), divided by the total number of AFM recommendations. With this submission, Edwards is seeking clearance for the AFM Prompt Reclassifier algorithm (AFM PR algorithm) to the Acumen AFM Software Feature. The AFM Prompt Reclassifier algorithm is intended to be used in conjunction with the core AFM algorithm to re-assess the fluid bolus recommendations provided by the core alqorithm. It analyzes the patient's current hemodynamics for either confirming (corroborating) the original prompt or reclassifying the prompts (i.e., reclassify a "Test Bolus Suggested" prompt to a "Fluid Bolus Suggested" prompt or vice versa). In doing so, it acts as a secondary check for the fluid bolus prompts such that a greater number of the "Fluid Bolus Suggested" prompts lead to the desired change in stroke volume. Through refined prompt adjustments informed by real-time hemodynamic data, the AFM PR algorithm aims to improve patient responsiveness, thereby optimizing the impact of the AFM Software Feature on patient hemodynamics.

The Fogarty Fortis Arterial Embolectomy Catheters are indicated for use in adult patients for the removal of fresh, soft emboli and thrombi from vessels in the peripheral arterial system.

The Fogarty Fortis Arterial Embolectomy Catheters provide a means of clearing emboli and thrombi from vessels in the arteries of the peripheral system through inflation of the balloon and engagement with the arterial wall beyond the vascular obstruction followed by gentle withdrawal of the catheter thereby removing the obstruction from its position. The device catheter size is 4F and are available in 40 cm and 80 cm lengths. The device consists of a radiopaque catheter shaft with an integrated elastomeric latex balloon and an atraumatic tip that is inserted surgically into arterial vessels of the peripheral system. A hub at the proximal end is used for balloon inflation.

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.