Community Research and Development Information Service - CORDIS

H2020

EVA Report Summary

Project ID: 691519

Periodic Reporting for period 1 - EVA (EVA - patient ventilation beyond limits)

Reporting period: 2015-11-01 to 2016-04-30

Summary of the context and overall objectives of the project

EVA - Expiratory Ventilation Assistance – , or expiration by suction, is an innovative method to mechanically ventilate patients and is a key step in ventilation towards less-invasive, tailored and improved patient care as it enables:1. Full ventilation through a thin catheter instead of a thick tube 2. Controlling the expiration, reducing sheer stress, which may prevent lung injury and improve patient outcome 3. Low and – if needed – negative pressures in the lungs promoting blood circulation. The EVA technology has already been on the market for some years in its most basic form: the manual, disposable emergency ventilator Ventrain®. Since market launch in 2011, Ventrain® is now being sold by 16 distributors in over 20 countries. Ventinova’s flagship is the “EVA device”, now called Evone®: a fully automated ventilator based on EVA technology meeting the emerging needs of less invasive, tailored and improved patient care. First is focused on the large markets of elective surgical procedures and emergency care (€ 400 M, globally) and in 2nd generation on ICU-ventilation (€ 500 M, globally), before becoming ‘standard care’ (€ 4.6 billion, globally). The device, at start of the project at TRL6, is still in development and CE marking is expected in Q4 2016. Next to marketing activities, such as organizing workshops and training sessions, and careful selection and support of distributors, penetration of the conservative medical market should be ensured by demonstration of better and tailored patient care using EVA ventilation in pre-clinical studies and controlled clinical trials. These are to be designed and executed in close collaboration with Key Opinion Leaders (KOLs) of established and world leading academic medical centers. The described technology and products are protected by 5 patent families and design and brand registrations. The products are manufactured in The Netherlands and a dedicated smalle lumen catheter Tritube® in Ireland. After CE marking, large non-EU markets are to be entered.

Six milestones were defined in the project :
1. Prototype – similar to final product in all aspects - performs well in pig study in Operating Room.
2. 1st version EVA device Evone® CE marked
3. EVA device Evone® FDA cleared
4. Clinical benefit
a. safe and proper ventilation using Evone® in “general patients”
b. significant clinical benefit in three specific patient populations
5. Life cycle management system running: technical aftersales service, updates, repairs
6. Acceptance by ‘Innovators’, KOL’s, demonstrated by first sales

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

A prototype of the EVA device (brand name Evone®) was developed and tested in a clinically relevant setting in healthy pigs. A safe and adequate ventilation for 6 hours was demonstrated, marking the achievement of Milestone 1. Usability and validation feedback was obtained during this experiment, used for implementing device improvements. Verification tests were performed. Electromagnetic compatibility (EMC) testing confirmed that the EVA device withstands the applicable severity level and meets the performance criterion.
Evone prototype was demonstrated at the World Airway Management Meeting 2015 (Dublin) and at Euroanaesthesia 2016 (London) in order to gather end user feedback and to initiate a first step in acceptance by end users and KOLs. An abstract describing results of the pre-clinical study was submitted to the BMT conference and a manuscript is in preparation.
Currently 2/3 of the CE file is submitted to the Notified Body (DEKRA, NL). CE mark is expected in Q4 2016.
After obtaining CE mark, clinical studies will be executed aiming to evaluate ventilation performance in the ‘general’ population and in specific patients groups, aiming to detect significant clinical benefits. Currently protocols are (being) written for a second pre-clinical study and for several clinical studies.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The first in vivo results of the project suggest that next to adequate and safe ventilation, ventilation with Evone improves gas exchange due to increased alveolar ventilation.
Together with the fact that only a small lumen endotracheal tube Tritube®, (OD 4.4 mm and ID <3 mm) was used to efficiently ventilate, this study demonstrates the innovative and ground breaking character of this new ventilation technique.
The EVA consortium has always been convinced that the EVA technology is the solution for specific unmet clinical needs in several medical market segments. The first results confirm our hypotheses regarding clinical benefits of EVA ventilation in specific patient groups. Most obviously, patients undergoing upper airway surgery will benefit due to the reduced endotracheal tube size, providing significantly more view and working space for the surgeon. Also the smaller tube may enhance faster intubation and reduce intubation associated tracheal/laryngeal trauma. The controlled expiration provided by Evone, may benefit patients who generally suffer from alveolar collapse during mechanical ventilation (e.g. obese patients). Evaluation of clinical benefit and safety in these and other specific patient groups will be evaluated in the project. Demonstrating benefits of EVA technology in the ‘general patient’ will increase the impact of this new technology and is therefore under consideration.

Related information

Record Number: 190401 / Last updated on: 2016-11-15
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