Project description
Safer large-bore vascular closure device
Significant advances in medical technologies have enabled the development of transcatheter procedures to replace open-heart surgeries. These procedures lead to improve clinical results, shorter hospital stays and faster recovery times, however, they require large access sites in the vessels. Closure of these large access sites is associated with a high rate of complications. The EIC-funded NVCD project will develop a proprietary micro-suturing technology to achieve more efficient and safer large-bore vascular closure. Following prototype development and preclinical validation, the project will conduct clinical trials to obtain CE certification for commercial deployment of the suturing device.
Objective
Cardiovascular diseases (CVDs) remain a major health problem worldwide and a leading cause of mortality, with over annual 18 million deaths. In Europe, CVDs are associated with 4 million deaths and costs of around 210 billion per year.
Many surgeries to treat cardiac conditions are shifting to be minimally invasive and this is a trend expected to continue growing due to its multiple advantages over open interventions. However, as newly developed devices for transcatheter procedures become bigger they also require larger vascular access sites. A couple of devices are used in vascular large-bore closure (e.g. ProGlide from Abbott). However, they are associated with still high vascular and bleeding complications (up to 20%, depending on the operators skills). Such complications are linked to longer hospitalizations, unnecessary suffering, and greater healthcare costs (20k per patient), as well as higher morbidity and mortality.
To solve this persistent unmet need in the field of cardiovascular surgery, Novelrad has specifically developed the NVCD closure device. It integrates a proprietary and revolutionary micro-suturing technology that mimics the standard surgical technique, effectively delivering a multipoint continuous suture in a minimally invasive manner. The NVCD is easy to use and enables a safer closure of large bores, potentially reducing complication rates to 3%, saving up to 15 min in the procedure, and bringing important cost savings related to same-day discharge and complications management. Importantly, with a single NVCD device large and extra-large bore closure of veins and arteries is possible (up to 30Fr).
After obtaining a fully functional prototype of the NVCD and advancing in pre-clinical tests, we now aim to perform a first-in-human (FIH) study and complete the clinical trial required to obtain its CE certification as a Class III medical device. This will be crucial to prepare for industrialization and commercial deployment in Europe and globally.
Fields of science (EuroSciVoc)
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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.
- social sciences sociology demography mortality
- medical and health sciences clinical medicine surgery
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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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HORIZON.3.1 - The European Innovation Council (EIC)
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Topic(s)
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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.
HORIZON-EIC-ACC-BF - HORIZON EIC Accelerator Blended Finance
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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) HORIZON-EIC-2023-ACCELERATOR-01
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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.
3882000 METZER
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.