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LAA-START SIGNED

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

Total Cost €

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EC-Contrib. €

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Partnership

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 LAA-START project word cloud

Explore the words cloud of the LAA-START project. It provides you a very rough idea of what is the project "LAA-START" about.

total    af    human    least    caused    opening    atrial    fda    patients    efficacy    invasive    fitting    procedure    laa    financially    risk    clinical    resistant    contraction    first    entering    occlusion    shut    redo    data    healthcare    prevent    stroke    device    time    electrical    fibrillation    medication    markets    france    permanently    implant    million    mechanically    destroys    flow    aurigen    treating    tissue    heartbeat    electrically    works    isolation    30    irregular    muscle    initial    amounting    complete    billion    fti    paf    symptomatic    persistent    doubles    approximately    left    5bn    ablation    stream    surgical    hours    72    rates    appendage    uk    wasted    isolates    implants    q3    incapable    pulses    fit    medical    2020    blood    surgery    shot    enter    abnormal    health    13    ce    market    catheter    regulatory    safety    arrhythmia    classified    too    italy    clots    certification    services    causing    germany    doubled    line    therapy    cardiac    heart    filter    opportunity    minimally   

Project "LAA-START" data sheet

The following table provides information about the project.

Coordinator
AURIGEN MEDICAL LIMITED 

Organization address
address: 18 CHURCHWELL SQUARE
city: DUBLIN
postcode: DUBLIN 13
website: n.a.

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Ireland [IE]
 Total cost 5˙012˙590 €
 EC max contribution 2˙999˙998 € (60%)
 Programme 1. H2020-EU.3. (PRIORITY 'Societal challenges)
2. H2020-EU.2.1. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies)
 Code Call H2020-EIC-FTI-2018-2020
 Funding Scheme IA
 Starting year 2019
 Duration (year-month-day) from 2019-01-01   to  2020-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    AURIGEN MEDICAL LIMITED IE (DUBLIN) coordinator 1˙115˙458.00
2    TELEFLEX MEDICAL EUROPE LIMITED IE (ATHLONE CO. WESTMEATH) participant 953˙470.00
3    UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK IE (Cork) participant 516˙948.00
4    MEDIBRANE LTD IL (ROSH HAAYIN) participant 334˙600.00
5    CESKE VYSOKE UCENI TECHNICKE V PRAZE CZ (PRAHA) participant 79˙522.00

Map

 Project 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.

 Deliverables

List of deliverables.
Clinical Affairs Director Appointed Other 2020-04-02 09:09:54
Biostatistician Appointed Other 2020-04-02 09:10:11
Manufacturing Engineer Appointed Other 2020-04-02 09:10:03

Take a look to the deliverables list in detail:  detailed list of LAA-START deliverables.

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