Device

Abstract

The Emergency Ventricular Support (EVS) is an innovative cardiological device, belonging to the Ventricular Assist Device (VAD) category. Is is a contrivance that, due to its unique capability to be installed in a very short time and to assist or replace completely the heart functionality of pumping the blood for a period of time long enough to put in place the necessary medical measures, it can be reversibly applied to the following major purposes:

Prevention

EVS will represent a significant evolutive change of the current therapeutic approach to the heart attack, as it will allow for the adoption of medical protocols more prevention oriented than they are today. For instance, targeting sets of population of individuals ranked as at high risk of heart attack, campaigns of invasive preventive exams could be launched thanks to the use of EVS that will minimize the risks so achieving the double result of:

Carrying out an healing intervention, if deemed as necessary, meanwhile performing the blood vessel examination;
Achieving a deep (EVS enables a time independent investigation) awareness of the status of the patient so to prescribe the best cure to prolong his life with the highest level of quality attainable.

Treatment of Heart Attack or other Heart Pathologies

EVS will be inserted once a heart attack or any other cardiological pathology makes the heart damaged and therefore either partially working or completely down. EVS will rapidly restore the physiological conditions of blood circulation dynamic parameters (flow, pressure, etc…) and allow for the achievement of a stabilized condition that can be prolonged as long as the surgeon and his team will have identified and decided what is the best intervention to carry out. By relieving a damaged heart to continue to pump or by replacing a heart that has stopped working, EVS will dramatically reduce the mortality rate associated to cardiac impairment.
EVS allowing to put in stand-by the heart as long as necessary, paves the road for new techniques aimed at cleaning or repair of coronary wounds and plates intervening inside the blood vessel and, if necessary, distributing the operation through several steps on more than one day. All these results are achieved with a level of risk lower than all the ordinary procedures applicable today, including for example STENT application (STENT have saved millions of human lives, however this technique presents limitations in terms of duration and obliges patients to take anticoagulant medicines lifelong)
 
The innovation it brings is based on the simplicity and extremely compactness of its guidewires that can be groin inserted, so allowing for applications of EVS also in environments different from the surgical suite (bed-side insertion), by trained and qualified operators and using only an ultrasound scanner to achieve the most appropriate positioning of EVS into the large blood vessels (aorta, vena cava inferior, vena cava superior ). These important features will allow for EVS to be fitted in all ambulance vehicles intended to intervene on heart diseases.

The high reliability of the double pulsatile blood pump and the associated control & management unit, compliant with the applicable quality and safety critical standard, completes the disruptive innovation brought by EVS in the current best practices of heart diseases’ prevention, surgery and treatments.

IP Status

Italian patent no. 102018000006538

granted on 08 July 2020

US patent 11,951,296 B2

granted on 09 April 2024

Media

MLB PoC

Giuseppe Mele

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