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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.

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The Edwards 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 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 is not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter.

The Acumen Hypotension Prediction Index parameter (HPI) provides the clinician with the likelihood that the patient may be trending toward a hypotensive event. The Acumen HPI feature is intended for use in surgical or non-surgical patients. By default, the software defines a hypotensive event as mean arterial pressure (MAP) < 65 mmHg for at least one minute in duration. This MAP target is adjustable and can be changed to 55, 60, 70, 75, 80 or 85 mmHg.

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 surgical or nonsurgical 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 Acumen Hypotension Prediction Index feature consists of software running on the Edwards Lifesciences HemoSphere Advanced Monitoring Platform paired with the Acumen IQ extravascular blood pressure transducer (K152980) and a peripheral arterial catheter. The monitoring system includes the Acumen Hypotension Prediction Index (HPI), and graphical user interface features displaying hemodynamic parameters relevant to assessing the root cause of a potential hypotensive event. The Acumen Hypotension Prediction Index is an index related to the likelihood of a patient experiencing hemodynamic instability defined as a hypotensive event* within 15 minutes, where zero (0) indicates low likelihood and one hundred (100) indicates a hypotensive event is occurring. The Acumen Hypotension Prediction Index parameter (HPI), should not be used exclusively to treat patients. A review of the patient's hemodynamics is recommended prior to initiating treatment. * A hypotensive event is defined as mean arterial pressure (MAP) < 65 mmHg for one minute in duration

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 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 Hypotension Prediction Index (HPI) parameter.

The Acumen Hypotension Prediction Index Feature (DEN160044) consists of software running on the Edwards Lifesciences EV1000 Clinical Platform (DEN160044) and HemoSphere Advanced Monitoring Platform (K180881) paired with the FloTrac IQ or Acumen IQ extravascular blood pressure transducer (K152980) and a radial arterial catheter. The software includes the Acumen Hypotension Prediction Index (HPI), the Dynamic Arterial Elastance Parameter (Eadyn), the Systolic Slope Parameter (dP/dt), and additional graphical user interface features. The Acumen Hypotension Prediction Index is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure < 65 mmHg for one minute in duration) within 15 minutes, where zero (0) indicates low likelihood and one hundred (100) indicates high likelihood. The Acumen Hypotension Prediction Index, HPI, should not be used exclusively to treat patients. A review of the patient's hemodynamics is recommended prior to initiating treatment.

The Edwards Lifesciences Acumen Hypotension Prediction Index (HPI) 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 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 Acumen Hypotension Prediction Index Feature ("the device") consists of software running on the Edwards Lifesciences EV1000 Platform (previously cleared under K100709, K110597, K131892. K140312, and K160552) paired with the FloTrac IQ extravascular blood pressure transducer (K152980) and a radial arterial catheter. The device includes the Hypotension Prediction Index (HPI), the Dynamic Arterial Elastance Parameter (Eagyn), the Left Ventricular Contractility Parameter (dP/dt), and additional graphical user interface features. HPI is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure (MAP) <65 mmHg for one minute in duration) within fifteen minutes, where zero (0) indicates low likelihood and one hundred (100) indicates high likelihood. The EV1000 Platform initiates a high priority alarm (red) when HPI exceeds 85. The Hypotension Prediction Index, HPI, should not be used exclusively to treat the patients. A review of the patient's hemodynamics is recommended prior to initiating treatment. HPI is not defined by a single equation. HPI uses features extracted from FloTrac IQ measurements, some compared to an initial base value determined over the first 10 minutes of the patient monitoring session, to a data-driven model developed from retrospective analysis of an arterial waveform database collected from ICU and OR patients containing annotated hypotensive (defined as MAP <65 mmHG for at least 1 minute) and non-hypotensive events. Eadm is a physiologic parameter related to left ventricular afterload relative to the left ventricular elastance. It is calculated by dividing Pulse Pressure Variation (PPV) by Stroke Volume Variation (SVV), or Eadyn = PPV/SVV. dP/dt is a physiologic parameter related to the change in contractility of the left ventricle. It is calculated as the maximal first derivative of the arterial pressure waveform with respect to time. Additional graphical user interface features include the HPI High Alert Popup, which displays when HPI exceeds 85 for two consecutive 20-second updates or reaches 100 at any time, and the HPI Secondary Screen, which consolidates hemodynamic parameters into a single screen.