Skip to main content

Left Atrial Appendage Electrical Isolation via Bio-photonic Optical Confirmation to Treat Persistent Atrial Fibrillation

Objective

Atrial Fibrillation (AF) is an irregular heartbeat caused by abnormal electrical activity in the heart, that can lead to blood clots with high risk of stroke and heart failure.
There are 10.7 million AF patients across Europe and the US, 3.6 million are classified as having Persistent AF (PAF), they are highly symptomatic and medication resistant. Surgical electrical therapy (catheter ablation) destroys heart tissue causing the abnormal electrical pulses. For PAF patients, this works only 30% of the time. Approximately 72% of PAF patients require at least one redo procedure, amounting to €13.5 billion in wasted healthcare costs.
Success rates are doubled if electrical activity in a part of the heart “the Left Atrial Appendage” (LAA), is shut down. But this increases stroke risk from blood clots as the LAA is now incapable of muscle contraction to maintain blood flow.
LAA implants, “occlusion devices” fit across the opening of the LAA to filter the blood and prevent clots from entering the blood stream. However, fitting an occlusion device during the same procedure as LAA electrical isolation doubles procedure time (to 7 hours) making it non-financially viable for health services and too high risk for patients.
AuriGen Medical have developed a unique, minimally invasive cardiac implant which permanently electrically and mechanically isolates the LAA in a one-shot procedure: treating both the stroke and arrhythmia risk associated with PAF with no increase in surgery time.
This multi-partner FTI project will complete product development in line with the regulatory development pathway for medical devices for first in human safety and efficacy clinical studies required for CE certification and contributing to FDA clinical data requirements. The total market opportunity is $5bn/yr market opportunity across the EU and US. AuriGen will enter the market directly in the initial target European markets (Germany, France, Italy and UK) during Q3 2020.

Call for proposal

H2020-EIC-FTI-2018-2020
See other projects for this call

Funding Scheme

IA - Innovation action

Coordinator

AURIGEN MEDICAL LIMITED
Address
18 Churchwell Square
DUBLIN 13 Dublin
Ireland
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 1 115 458

Participants (4)

MEDIBRANE LTD
Israel
EU contribution
€ 334 600
Address
23 Hamelacha St
4809173 Rosh Haayin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
TELEFLEX MEDICAL EUROPE LIMITED
Ireland
EU contribution
€ 953 470
Address
Ida Business And Technology Park, Dublin Road
Athlone Co. Westmeath
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK
Ireland
EU contribution
€ 516 948
Address
Western Road
T12 YN60 Cork
Activity type
Higher or Secondary Education Establishments
CESKE VYSOKE UCENI TECHNICKE V PRAZE
Czechia
EU contribution
€ 79 522
Address
Jugoslavskych Partyzanu 1580/3
160 00 Praha
Activity type
Higher or Secondary Education Establishments