Ventricular Assist Device Functional Verification System

Ventricular Assist Device Functional Verification System

It enables real-time and accurate plotting of the left ventricular P-V loop, and is applied to the performance verification of ventricular assist devices such as IABP.

As the industry's premier physiological-level simulation and testing platform with real-time left ventricular P-V loop waveform output, Simuheart Pump​ is specially developed for manufacturers of IABP, LAVD, Impella and other related ventricular assist devices for in vitro verification and performance testing. It provides credible data basis and test reports to support product registration and certification.

In the whole process of in vitro simulation, registration & certification, and hospital promotion for ventricular assist devices such as IABP (Intra-Aortic Balloon Pump), enterprises commonly face core pain points: inaccurate R&D test data, lack of data support for in vitro simulation equipment, insufficient scenario-based clinical training demonstration, and poor practical operation experience for medical staff.

Targeting the above industry demands, Trandomed launches this Ventricular Assist Device Functional Verification System. It delivers a one-stop solution with four core powerful functions, and is currently the first platform on the market capable of real-time left ventricular P-V loop plotting and synchronous data acquisition for R&D and performance testing of medical devices.
Core Functions：
1. High-fidelity Physiological Environment Simulation

High Simulation Performance

Equipped with real-time P-V loop plotting function, the system synchronizes with the operating cycle of the pulsatile pump required for IABP devices, and dynamically plots the left ventricular P-V loop in real time, with a fitting degree of over 90% compared with clinical statistical results.

Multi-physiological Scenario Simulation

It accurately simulates changes of the left ventricular P-V loop under different physiological states including normal cardiac condition and heart failure, and reproduces core data differences before and after counterpulsation. It helps enterprises optimize algorithms and adjust parameters via in vitro simulation, greatly cutting early R&D costs and shortening the R&D cycle.

2. Real-time Waveform & Data Acquisition for Registration Documentation

Traceable Raw Data

High-precision sensors are adopted to collect real-time pressure (P) and volume (V) data on the Simuheart Pump, fully replicating the clinical monitoring workflow.

The acquired data is precise and credible, serving as the core reference for device performance verification and safety evaluation. It meets the regulatory requirement of attaching detailed simulation data in technical documentation, reduces supplementary revision procedures, and accelerates regulatory approval.

3. Hemodynamic Simulation to Expand Testing Scenarios

Hemodynamic Evaluation

Built-in ultrasonic flow sensors accurately detect aortic flow and flow velocity and generate corresponding waveforms, reproducing the superposition effect of blood flow under the synergistic operation of pulsatile pumps and ventricular assist devices.

Trigger Logic Verification

Dual-mode inflation/deflation trigger signals are compatible with the trigger logic of clinical IABP main units. It supports in-depth testing of trigger modes and counterpulsation effects to ensure the device fully adapts to actual clinical needs.

Technical Specifications：
1.Pulsatile Pump: Heart rate 1–200 BPM; Stroke volume 1–150 ml; Cardiac output 1–10 L/min

2.Blood Pressure Range: 0–300 mmHg

3.Flowmeter: Monitoring range 0–20 L/min; Overall accuracy: 2%

This simulation system provides accurate and efficient technical support throughout the R&D, testing and clinical market expansion stages for domestic ventricular assist device manufacturers, effectively accelerating the overall R&D and commercialization process.