Project description
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.
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 (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences clinical medicine cardiology cardiovascular diseases cardiac arrhythmia
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs
- medical and health sciences basic medicine neurology dementia
- medical and health sciences basic medicine neurology stroke
- medical and health sciences medical biotechnology implants
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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H2020-EC - Horizon 2020 Framework Programme
MAIN PROGRAMME
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H2020-EU.3. - PRIORITY 'Societal challenges
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H2020-EU.2.1. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
IA - Innovation action
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) H2020-EIC-FTI-2018-2020
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
DUBLIN 13 Dublin
Ireland
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.