Project
VenCoM (Venous Congestion Meter) is a non-invasive device designed for measuring venous pressure in hospital, outpatient, or home settings.
It functions as a plethysmographic device, similar to a standard sphygmomanometer used for measuring arterial pressure, but with two pneumatic cuffs: one placed on the upper arm to occlude venous flow when the applied pressure exceeds the existing venous pressure, and the other on the forearm to detect volume changes induced by the occlusion, as a result of rapid vascular expansion in the forearm. Based on the interactions of these applied pressures on the arm and the resulting variations detected in the forearm, and using an innovative algorithm, the device estimates CVP (Central Venous Pressure) within minutes.
The VenCoM device is intended for use in various pathological conditions where monitoring hemodynamic status is essential, including heart failure (HF), pulmonary hypertension (PH), kidney dysfunction, and liver dysfunction.
Client
Industries
Our added Value
Teoresi MedTech is responsible for the development of the hardware and software components of the VenCoM device, based on the project requirements defined in collaboration with TRE ESSE Progettazione Biomedica s.r.l. and compliance with current European regulations for medical devices. Teoresi MedTech’s added value comes from decades of experience in embedded electronics, industrialized prototyping of medical device hardware and software, and managing regulatory pathways for CE marking.
In building the VenCoM device, a venous congestion meter, Teoresi MedTech’s expertise enabled them to oversee the entire development cycle following European medical regulations, from requirement specification (system, hardware, and software) to device production and validation. Specifically, Teoresi MedTech selected the hardware components and designed electronic boards suited to the required functions, ensuring compliance with European medical standards. For software design, all architectural and detailed design activities were conducted to implement the necessary functionalities in line with European medical standards.
Results
The VenCoM device provides crucial information about patient’s health status and enables early detection of potential venous congestion crises, potentially predicting acute HF events several days in advance. Events that typically require hospitalization. By preventing acute decompensation events and reducing hospital admissions, patients experience improved quality of life and increased life expectancy.
Key benefits of the VenCoM device include:
- It is non-invasive and ensures patient safety and comfort;
- It is easy to use, as its intuitive design is suitable for both healthcare providers and patients;
- It is highly reliable, providing accurate measurements;
- It is versatile, effective for both hospital and home monitoring;
- It is inclusive, as it is suitable even for patients with arrhythmias;
- It is easily integrable with standard blood pressure monitors.