Community Research and Development Information Service - CORDIS

H2020

EVA Report Summary

Project ID: 691519

Periodic Reporting for period 2 - EVA (EVA - patient ventilation beyond limits)

Reporting period: 2016-05-01 to 2016-10-31

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 over five 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 mechanical 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 and in 2nd generation on ICU-ventilation, before becoming ‘standard care’. The device, at start of the H2020 project EVA at TRL6, is still in development and CE marking is expected in early2017. 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 small lumen catheter Tritube (OD 4.4 mm) 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. (Achieved 15 April 2016)
2. 1st version EVA device Evone CE marked
3. EVA device Evone FDA cleared
4. Clinical benefit by demonstrating
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

Note: EVA, Ventrain, Evone and Tritube are registered trademarks.

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 of this project. This study was presented at the BMT 2016 conference in Basel and very well received. A manuscript is submitted for scientific publication.
An Evone prototype was demonstrated at a.o. the World Airway Management Meeting 2015 (Dublin), at Euroanaesthesia 2016 (London) and at the Cutting Edge Laryngology Conference 2016 (London). End user feedback was gathered and a first step in acceptance by end users and KOLs is herewith initiated. Usability and validation feedback obtained during the in-vivo study and during conferences were used as input for device improvements.
Further, verification bench tests were performed evaluating a.o. Evone’s performance and robustness. Electromagnetic compatibility (EMC) testing confirmed that Evone withstands the applicable severity level and meets the performance criterion.
Now the complete CE file was submitted to the Notified Body (DEKRA, NL). CE marking is expected in Q2 2017.
After obtaining CE marking, clinical studies will be executed, which aim to evaluate Evone’s ventilation performance in the ‘general’ population and in specific patients groups, and to detect significant clinical benefits.
Currently, protocols are (being) written for a second in-vivo study and for quite a few clinical studies.

Note: EVA, Ventrain, Evone and Tritube are registered trademarks.

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.
Patients who generally suffer from alveolar collapse during mechanical ventilation (e.g. obese patients) may benefit from the controlled expiration provided by Evone.

Evaluation of clinical benefit and safety in these and other specific patient groups will be evaluated in the H2020 EVA project. Demonstrating benefits of EVA technology in the ‘general patient’ will increase the impact of this new technology and is therefore under consideration.

Note: EVA, Ventrain, Evone and Tritube are registered trademarks.

Related information

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