Acumen Hypotension Prediction Index – EV1000 Clinical Platform

by Edwards Lifesciences  · Based in United States → — Predicting and managing hypotension before it occurs.
Anesthesiology Critical Care Emergency Medicine

Contact-for-pricing
Regulatory Status Disclosed

Overview

The Acumen Hypotension Prediction Index (HPI) software is a pioneering technology developed by Edwards Lifesciences, designed to detect and help clinicians manage hemodynamic instability and predict the likelihood of hypotensive events. It operates on the HemoSphere Advanced Monitoring Platform, and previously on the EV1000 Clinical Platform. The software utilizes a machine-learning based algorithm that analyzes over 2.6 million features from a single arterial pressure waveform, comparing them against 133 million different waveforms to identify factors that predict hypotension up to 15 minutes before an event.

Key elements of the Acumen HPI software include the HPI Parameter, which displays a value from 0 to 100 indicating the likelihood of a hypotensive event; Smart Alerts and a Smart Trend screen that notify clinicians of potential trends toward hypotension; and a Relationship View screen. This Relationship View provides insights into the root cause of hypotension by visually arranging hemodynamic parameters related to preload, afterload, and contractility.

The Acumen HPI software aims to reduce the incidence and duration of intraoperative hypotension (IOH), which is strongly associated with risks of myocardial injury, acute kidney injury, and mortality. Studies have shown that using Acumen HPI software can significantly reduce the duration of IOH, with one study demonstrating a 57% reduction.

The software can be unlocked by either the minimally-invasive Acumen IQ sensor, which connects to an existing radial arterial line, or the noninvasive Acumen IQ cuff, providing continuous blood pressure and advanced hemodynamic parameters.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • HPI Parameter (0-100 likelihood score)
  • Smart Alerts for trending hypotension
  • Smart Trend screen
  • Relationship View screen (preload, afterload, contractility insights)
  • Machine learning-based algorithm for prediction
  • Predicts hypotension up to 15 minutes in advance
  • Continuous hemodynamic monitoring
  • Non-invasive (Acumen IQ cuff) and minimally-invasive (Acumen IQ sensor) options
  • Reduces duration of intraoperative hypotension
  • Acumen Analytics software for retrospective data analysis

Use Cases

  • Prevention of intraoperative hypotension (IOH)
  • Management of hemodynamic instability in surgical patients
  • Guidance for goal-directed hemodynamic therapy (GDHT)
  • Monitoring in non-cardiac surgery
  • Monitoring in cardiac surgery
  • Patient monitoring in intensive care settings

What Physicians Need to Know

Hypotension Prediction Index (HPI)
The Acumen HPI software provides a predictive index (0-100) indicating the likelihood of a patient experiencing a hypotensive event (Mean Arterial Pressure < 65 mmHg for at least one minute) within 15 minutes.
Real-Time Alert Capability
The EV1000 Platform initiates a high-priority alarm (red) when the HPI exceeds 85. Smart Alerts and HPI high alert pop-ups appear when the HPI value exceeds 85 for two consecutive 20-second updates or reaches 100, prompting review of patient hemodynamics.
Hemodynamic Parameter Insights
A secondary screen provides insights into the cause of hypotension, visually arranging hemodynamic parameters by preload (e.g., Stroke Volume Variation/Pulse Pressure Variation), afterload (Dynamic Arterial Elastance - Eadyn), and contractility (Systolic slope - dP/dt).
Cardiac Monitoring Integration
The software runs on the Edwards Lifesciences EV1000 Clinical Platform and is compatible with the FloTrac IQ extravascular blood pressure transducer, Acumen IQ sensor (minimally-invasive arterial line), and Acumen IQ cuff (non-invasive finger cuff). It also integrates with the HemoSphere advanced monitoring platform.
Machine Learning Algorithm
The Acumen HPI software was developed using artificial intelligence, specifically machine learning, to analyze arterial pressure waveform features and predict hypotension.
Reduced Hypotension Incidence/Duration
Studies have shown that using Acumen HPI software can significantly reduce the incidence, duration, and severity of intraoperative hypotension in noncardiac surgery patients.
Heart Failure Risk Prediction
While it provides hemodynamic parameters relevant to cardiac function, it is not explicitly marketed or indicated as a heart failure risk prediction tool.
Physician Tip

The Acumen HPI software is an adjunctive decision support tool intended to provide clinicians with physiological insight into a patient's likelihood of future hypotensive events and their potential causes (preload, afterload, contractility). It is crucial to review the patient's complete hemodynamic state and other clinical information before initiating any therapeutic decisions, as the HPI parameter should not be used exclusively to direct therapy.

The Acumen Hypotension Prediction Index software is integrated into the Edwards Lifesciences EV1000 Clinical Platform and is compatible with various Edwards advanced hemodynamic monitoring solutions, including the FloTrac IQ sensor, Acumen IQ sensor (for invasive arterial lines), and the non-invasive Acumen IQ cuff. It is also compatible with the HemoSphere advanced monitoring platform.

Details

Category Cardiology AI, Surgical AI, Triage & ER/ICU AI
Pricing Contact-for-pricing
DeploymentIntegrated with Edwards Lifesciences HemoSphere Advanced Monitoring Platform (and previously EV1000 Clinical Platform) via dedicated sensors (Acumen IQ cuff or sensor).
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

The Acumen Hypotension Prediction Index (HPI) software received a De Novo request from the U.S. FDA in March 2018, designated as an adjunctive predictive cardiovascular indicator. It also received 510(k) clearance (K183646) on May 21, 2019, for use with the EV1000 Clinical Platform and HemoSphere Advanced Monitoring Platform. Additionally, the Acumen HPI software with the noninvasive Acumen IQ finger cuff received U.S. FDA 510(k) clearance in June 2021.

Integrations
EHR Not specified
Specialties Anesthesiology, Critical Care, Emergency Medicine

What the Web Says

The Acumen Hypotension Prediction Index (HPI) software, used with the EV1000 Clinical Platform, is a machine learning-derived tool designed to predict and help clinicians manage intraoperative hypotension (IOH) in surgical patients. It analyzes arterial pressure waveforms to provide a likelihood of a hypotensive event (MAP < 65 mmHg for at least one minute) and offers insights into the potential root causes, such as preload, afterload, and contractility issues. Studies have shown that its use can significantly reduce the incidence, duration, and severity of IOH, potentially leading to improved patient outcomes.

Overall: Positive

Strengths

  • Significantly reduces the incidence, duration, and severity of intraoperative hypotension.
  • Provides early warning of impending hypotensive events, allowing for proactive intervention.
  • Offers insights into the underlying physiological causes of hypotension (preload, afterload, contractility).
  • Demonstrates superior predictive abilities compared to traditional hemodynamic parameters.
  • Can improve compliance with goal-directed hemodynamic therapy algorithms.
  • Compatible with Edwards' advanced hemodynamic monitoring solutions, including the EV1000 and HemoSphere platforms.

Limitations

  • Requires an arterial line for monitoring in many cases, which is an invasive procedure.
  • The HPI parameter itself should not be the sole basis for therapeutic decisions; clinicians must consider underlying physiology.
  • Some Reddit users express skepticism or find the alerts can be overwhelming if not properly understood in the context of overall patient hemodynamics.
  • Effectiveness is often shown in conjunction with a treatment protocol, not just the software alone.
  • Limited information from independent tech reviewers, G2, or Capterra was found in the search results.
  • Specific patient populations (e.g., those with significant cardiac valvular disease, atrial fibrillation, or on multiple vasoactive agents) may be excluded from studies.

Based on reviews from: Edwards Lifesciences, ClinicalTrials.gov, PubMed Central, ResearchGate, HT Medical Devices, Reddit, BD Learning Academy, PR Newswire, YouTube

Last updated: 2026-07-17

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Press & Coverage

FDA
510(k) Premarket Notification - Acumen Hypotension Prediction Index u2013 EV1000 Clinical Platform
This FDA premarket notification details the clearance of the Acumen Hypotension Prediction Index u2013 EV1000 Clinical Platform by Edwards Lifesciences, LLC, categorized under regulation number 870.2210 as an adjunctive predictive cardiovascular indicator. The document outlines the applicant, correspondent, and regulatory information for the device.
2019-05
Physician AI Tools
Acumen Hypotension Prediction Index u2013 EV1000 Clinical Platform vs Volta AF-Xplorer
This comparison highlights the Acumen Hypotension Prediction Index u2013 EV1000 Clinical Platform as a tool for proactively preventing and managing hypotensive events in critical care and surgical settings. It provides predictive insights up to 15 minutes in advance to help reduce intraoperative hypotension.
2024-07
FDA.report
Adjunctive Predictive Cardiovascular Indicator QAQ - FDA.report
This report defines the 'Adjunctive Predictive Cardiovascular Indicator' (product code QAQ) as a prescription device utilizing software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events, intended for adjunctive use. It lists several related 510(k) records, including the Acumen Hypotension Prediction Index u2013 EV1000 Clinical Platform.
2025-05
Physician AI Tools
Acumen Hypotension Prediction Index u2013 EV1000 Clinical Platform vs Tempus ECG-Low EF
This article compares the Acumen Hypotension Prediction Index u2013 EV1000 Clinical Platform with Tempus ECG-Low EF, noting that the Acumen HPI is designed for proactive management of hemodynamic instability by predicting hypotensive events. It provides early alerts for potential blood pressure drops.
2024-07
BEUDAMED
Hypertension Prediction Index (HePI) Algorithm - BEUDAMED
This entry from BEUDAMED notes the 'Hypertension Prediction Index (HePI) Algorithm' with regulation number 870.2210, and lists the Acumen Hypotension Prediction Index u2013 EV1000 Clinical Platform as a related device. The decision for the HePI Algorithm was 'Substantially Equivalent' on May 15, 2025.
2025-05
Physician AI Tools
Acumen Hypotension Prediction Index u2013 EV1000 Clinical Platform vs AHI System
This comparison highlights the Acumen Hypotension Prediction Index u2013 EV1000 Clinical Platform for its ability to provide real-time predictive analytics for hemodynamic instability, offering early warnings of patient deterioration. It aims to prevent adverse events and improve patient outcomes in critical care settings.
2024-07

Videos

Product demos, reviews, and walkthroughs for Acumen Hypotension Prediction Index – EV1000 Clinical Platform.

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Frequently Asked Questions

The Acumen HPI software integrates with the EV1000 Clinical Platform or the newer HemoSphere monitor, requiring an arterial catheter connected to a FloTrac IQ or Acumen IQ sensor. It displays a predictive index from 0 to 100 indicating the likelihood of a hypotensive event, and provides smart alerts when a threshold is exceeded. The system primarily utilizes arterial pressure waveform analysis and offers a secondary screen with advanced hemodynamic parameters like cardiac output and stroke volume variation to help identify the root cause of instability.
The Acumen HPI feature received De Novo request clearance from the U.S. FDA in 2018, with subsequent clearances for updated platforms, and also holds the CE Mark in Europe. As a medical device cleared by the FDA, it is expected to comply with stringent data privacy and security regulations, such as HIPAA, to protect patient information, although specific cybersecurity protocols were not detailed in the provided information.
The Acumen HPI algorithm has demonstrated high accuracy in predicting hypotension, often showing superior predictive performance compared to conventional hemodynamic parameters like cardiac output or mean arterial pressure. Its clinical utility lies in enabling proactive management by alerting clinicians to impending hypotensive events minutes before they occur, which can significantly reduce the duration and incidence of intraoperative hypotension compared to reactive approaches.
While the EV1000 platform is no longer sold, the newer HemoSphere monitor, which supports Acumen HPI, has reported costs around u00a327,470 for the monitor and u00a3400 per Acumen IQ sensor (excluding VAT). The value proposition includes potentially reducing postoperative complications like myocardial injury and acute kidney injury by minimizing hypotension, which could lead to decreased hospital costs and length of stay. However, some experts suggest that demonstrating direct cost savings can be challenging due to initial capital and ongoing transducer expenses.
The Acumen HPI is intended as supplementary information, and therapeutic decisions should not be based solely on the HPI parameter; a comprehensive review of patient hemodynamics is always recommended. Its accuracy can be compromised by factors such as improperly calibrated sensors, damped pressure lines, significant blood pressure fluctuations (e.g., with intra-aortic balloon pumps), extreme peripheral vasoconstriction, or excessive patient movement. It is also not recommended for patients with severe cardiac valvular disease, atrial fibrillation, acute heart failure, or those on multiple vasoactive agents.
The Acumen HPI is designed as an 'adjunctive predictive cardiovascular indicator' and explicitly states it is not intended to independently direct therapy, thereby preserving physician autonomy. It provides 'intelligent decision support' by alerting clinicians to impending hypotension and offering insights into the underlying causes (preload, afterload, contractility) through a secondary screen. The system utilizes 'smart alerts' to minimize alert fatigue, allowing clinicians to use their clinical judgment to respond to or disregard prompts.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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