Vivio® LVEDP System
Overview
The Vivio® LVEDP System is an innovative, FDA-cleared Class II medical device designed for the non-invasive diagnosis of heart failure. It enables clinicians to measure Left Ventricular End-Diastolic Pressure (LVEDP), which is a critical indicator and clinical hallmark of heart failure. The system utilizes a modified blood pressure cuff, a single-lead ECG, and advanced proprietary algorithms to capture and analyze brachial artery waveforms and heart data.
The Vivio System provides real-time results in less than five minutes, making it suitable for use in primary care settings, cardiology clinics, and even home health care environments. It aims to facilitate earlier detection of heart failure, particularly in high-risk patients, thereby enabling timely initiation of guideline-directed medical therapy (GDMT) and potentially reducing hospitalizations and emergency room visits.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Non-invasive LVEDP measurement
- Aids in early heart failure diagnosis
- Utilizes modified blood pressure cuff and single-lead ECG
- Employs advanced proprietary algorithms for data analysis
- Provides real-time results in under 5 minutes
- Portable for use in clinical or home health care settings
- Demonstrates superior sensitivity compared to echocardiography and BNP tests
- Accurately identifies patients with elevated LVEDP (80% sensitivity, 83% specificity)
- Prompts use of Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) for symptom assessment
Use Cases
- Early detection of heart failure in primary care settings
- Screening high-risk patients (e.g., with diabetes or chronic kidney disease) for heart failure
- Monitoring patients in home environments
- Guiding the initiation and titration of guideline-directed medical therapy (GDMT)
- Reducing hospitalizations and emergency room visits due to late-stage heart failure diagnosis
- Improving patient outcomes through earlier intervention
What Physicians Need to Know
The Viviou00ae LVEDP System offers a rapid, non-invasive method to accurately measure left ventricular end-diastolic pressure (LVEDP), a critical diagnostic marker for heart failure, directly in the primary care setting. This can significantly reduce diagnostic delays and facilitate earlier initiation of guideline-directed medical therapy (GDMT), particularly for high-risk patients (e.g., those over 65 with diabetes or chronic kidney disease). Its superior sensitivity compared to echocardiography for LVEDP detection makes it a valuable tool for screening and early intervention, potentially reducing hospitalizations and improving patient outcomes. Consider integrating it into routine workflows for at-risk populations to shift heart failure management from reactive to proactive.
The Viviou00ae System utilizes Bluetooth connectivity for its EKG patch and arm cuff to gather real-time physiological data. While explicit integrations with specific Electronic Medical Record (EMR) systems are not detailed, its design for use in primary care and potential home settings suggests the importance of seamless data flow into patient records for comprehensive management. The system's portability and rapid results are conducive to integration into existing clinical workflows, enhancing point-of-care diagnostics.
Details
| Category | Cardiology AI, Wearables & Remote Monitoring (RPM) |
| Pricing | Unknown |
| Deployment | On-premise (device) with mobile application |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
1 AI-estimated The Vivio® LVEDP System received FDA 510(k) clearance (K223905) on October 6, 2023, as a Class II medical device. The clearance was granted to Avicena, LLC (Pasadena, CA). The system is indicated to non-invasively estimate left ventricular end-diastolic pressure (LVEDP) above or below 18mmHg, aiding in the diagnosis of heart failure in adults when used by qualified healthcare professionals as an adjunct to other clinical information. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Emergency Medicine, Internal Medicine |
What the Web Says
The Viviou00ae LVEDP System is an FDA-cleared, non-invasive medical device designed to detect elevated left ventricular end-diastolic pressure (LVEDP), a key indicator of heart failure, in a primary care setting. It utilizes a modified blood pressure cuff, a single-lead Bluetooth-enabled ECG, and a proprietary physics-based algorithm to provide results in approximately five minutes. The system aims to enable earlier diagnosis and intervention for heart failure, potentially reducing hospitalizations and improving patient quality of life.
Overall: MixedStrengths
- Non-invasive and quick (around 5 minutes) test, reducing risks and costs associated with invasive procedures like cardiac catheterization.
- Enables earlier detection of heart failure in primary care settings, allowing for earlier intervention and management.
- Demonstrated higher sensitivity than other non-invasive methods like blood tests (BNP) and echocardiograms for measuring LVEDP.
- Can be integrated into routine primary care workflows, making heart failure screening more accessible.
- Reported to increase first-time heart failure diagnoses in primary care, decrease patient mortality, hospitalization, and ER visits, and improve medication compliance and quality of life.
- Portable and can potentially be used for patient monitoring in home environments.
Limitations
- Some research suggests that diagnostic performance may be reduced in clinically relevant populations where elevated LVEDP would actually be suspected, as opposed to healthy individuals.
- A small study on children and young adults showed promising results but requires validation in larger, well-designed trials.
- Real-world implementation studies have not consistently included confirmatory diagnostic testing to establish whether screening identifies true heart failure.
- There are no large, well-designed, published studies demonstrating that routine outpatient LVEDP measurement consistently improves heart failure management, clinical signs/symptoms, or reduces hospitalizations.
- One source indicates that non-invasive measurement of LVEDP in the outpatient setting is considered investigational and not medically necessary.
Based on reviews from: FirstWord HealthTech, Ventric Health, Business Wire, Morningstar, DAIC, PR Newswire, Reddit, Journal of the American Heart Association, PubMed, Aetna (via Clinical Policy)
Last updated: 2026-07-17
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Press & Coverage
Videos
Product demos, reviews, and walkthroughs for Vivio® LVEDP System.
Congestive Heart Failure (CHF): Left-sided vs Right-sided, Systolic vs Diastolic, Animation.
Frequently Asked Questions
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