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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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Outcomes and
results

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.

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

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 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.	IE (DUBLIN)	coordinator	1˙115˙458.00
2	TELEFLEX MEDICAL EUROPE LIMITED TELEFLEX MEDICAL EUROPE LIMITED Organization address address: IDA BUSINESS AND TECHNOLOGY PARK, DUBLIN ROAD city: ATHLONE CO. WESTMEATH postcode: n.a. 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.	IE (ATHLONE CO. WESTMEATH)	participant	953˙470.00
3	UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK Organization address address: WESTERN ROAD city: Cork postcode: T12 YN60 website: www.ucc.ie contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IE (Cork)	participant	516˙948.00
4	MEDIBRANE LTD MEDIBRANE LTD Organization address address: 23 HAMELACHA ST city: ROSH HAAYIN postcode: 4809173 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.	IL (ROSH HAAYIN)	participant	334˙600.00
5	CESKE VYSOKE UCENI TECHNICKE V PRAZE CESKE VYSOKE UCENI TECHNICKE V PRAZE Organization address address: JUGOSLAVSKYCH PARTYZANU 1580/3 city: PRAHA postcode: 160 00 website: www.cvut.cz contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	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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