Project description
For safe access to the pericardial space
Every year, about 2.5 million patients in the EU and the United States are treated by accessing pericardial space for effects from a variety of cardiac disorders like atrial fibrillation. Unfortunately, this treatment is based on access to the extremely thin double-walled sac surrounding the heart using a needle close to the working heart. It may cause heart damage and death due to lack of space and control. The EU-funded ViaOne project will bring about change by offering the EpiVIASYSTEM device to the medical market. It uses an innovative geometrically structured thread that allows for minimally invasive access to the outer surface of the heart, making this operation safe and effective for the first time.
Objective
2.5M patients per year in the US and the EU require pericardial space access as the result of a variety of pathological conditions. Atrial Fibrillation (AF) is the most common condition requiring pericardial access, in fact, AF affected 24M people in the US and 11M in the EU (2016). In current epicardial access techniques (using needles), complications can reach 4.5-30% (representing a ˞€600M/year increase in costs for healthcare systems) and includes heart puncture, cardiac tamponade and pericardial bleeding, which can result in an increase in patient deaths. The use of a needle in the heart area, which is in constant motion, requires a high level of skill and expertise during surgery.
EpiVIASYSTEM is the first device (PCT /IL2018 /050670) to ensure pericardial access in a confident, safe, needle-free manner avoiding complications during penetration of the pericardium. The device employs a unique geometrically structured thread that ensures a secure workspace for the use of additional cardiovascular devices, such as mapping and ablation catheters for treatment of arrhythmia disorders. Its design will ensure a competitive price of €250/procedure when compared with €130 for the equivalent tools used in invasive non-electrohpysiological procedures. EpiVIASYSTEM is expected to improve clinical outcomes of patients and reduce costs associated with failed ablations associated with the needle use by €600M/year. The increased growth of cardiac pathologies and the 2.5M of patients/year that require pericardial access represent a big business opportunity for the EpiVIASYSTEM and will favour its successful market uptake.
EpiVIASYSTEM´s main objective is to optimize, scale-up and commercialize a marketable medical device in both the EU and the US by 2021. For that, a feasibility study will be performed during SME Phase 1 to evaluate any technical, commercial and/or financial issues and ensure the successful release of the EpiVIASYSTEM into the market.
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.
- engineering and technology mechanical engineering manufacturing engineering
- medical and health sciences clinical medicine cardiology cardiovascular diseases cardiac arrhythmia
- medical and health sciences clinical medicine surgery
- medical and health sciences basic medicine pathology
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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-EU.2.3. - INDUSTRIAL LEADERSHIP - Innovation In SMEs
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.
SME-1 - SME instrument phase 1
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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-SMEInst-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.
1600101 NAZARETH
Israel
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.