Project description DEENESFRITPL Cardiac implant for the treatment of stroke and arrhythmia Atrial fibrillation (AF) is a condition characterised by irregular heartbeat caused by abnormal electrical activity that can lead to blood clots, stroke and heart failure. Millions of AF patients across Europe and the United States suffer from persistent AF (PAF), which is medication-resistant. Surgical electrical therapy destroys the heart tissue that causes the abnormal electrical pulses, but for PAF patients, this works only 30 % of the time. Irish AuriGen Medical has developed a minimally invasive cardiac implant that permanently isolates the left atrial appendage electrically and mechanically, treating both the stroke and arrhythmia risk associated with PAF with no increase in surgery time. The EU-funded LAA-START project will carry out clinical studies for safety and efficacy to complete product development as per the regulatory guidelines for medical devices. Show the project objective Hide the project objective 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. Fields of science medical and health sciencesclinical medicinecardiologycardiovascular diseasescardiac arrhythmiamedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsmedical and health sciencesbasic medicineneurologydementiamedical and health sciencesbasic medicineneurologystrokemedical and health sciencesmedical biotechnologyimplants Programme(s) H2020-EC - Horizon 2020 Framework Programme Main Programme H2020-EU.3. - PRIORITY 'Societal challenges H2020-EU.2.1. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies Topic(s) EIC-FTI-2018-2020 - Fast Track to Innovation (FTI) Call for proposal H2020-EIC-FTI-2018-2020 See other projects for this call Funding Scheme IA - Innovation action Coordinator AURIGEN MEDICAL LIMITED Net EU contribution € 1 115 458,00 Address 18 churchwell square DUBLIN 13 Dublin Ireland See on map Region Ireland Eastern and Midland Dublin Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 1 460 560,75 Participants (4) Sort alphabetically Sort by Net EU contribution Expand all Collapse all MEDIBRANE LTD Israel Net EU contribution € 334 600,00 Address 23 hamelacha st 4809173 Rosh haayin See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 143 400,00 TELEFLEX MEDICAL EUROPE LIMITED Ireland Net EU contribution € 953 470,00 Address Ida business and technology park, dublin road Athlone co. westmeath See on map Region Ireland Eastern and Midland Midland Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 408 630,00 UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK Ireland Net EU contribution € 516 948,00 Address Western road T12 YN60 Cork See on map Region Ireland Southern South-East Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,75 CESKE VYSOKE UCENI TECHNICKE V PRAZE Czechia Net EU contribution € 79 522,00 Address Jugoslavskych partyzanu 1580/3 160 00 Praha See on map Region Česko Praha Hlavní město Praha Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,50
