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An Embolic Protection Device for stroke prevention during heart valve replacement.

Project description

Heart valve replacement surgery could soon be much safer in the long run

The aorta is a very large blood vessel that acts as a conduit for oxygenated blood leaving the left ventricle on its way to the rest of the body. When the aortic valve narrows (aortic stenosis), your heart must work harder. This weakens the heart muscle, increases intracardial blood pressure, and eventually can even cause a heart attack. Transcatheter aortic valve implantation (TAVI) places a replacement valve without removing the damaged one. The downside of this minimally invasive surgery is the potential for dislodged tissue and debris entering the circulation with potentially dire consequences. CAPTIS has developed a device that can remove embolic particles during surgery. EU funding is supporting clinical trials and regulatory approval for commercialisation.

Objective

Aortic stenosis (AS) is the most common and most severe heart valve disease, affecting 20 million people worldwide. For
patients with severe AS, the most common treatment is valve replacement through Transcatheter Aortic Valve Implantation
(TAVI). The procedure is very risky, since embolic debris are released to the blood stream and may reach the brain and
other organs, reducing or blocking the blood flow. Strikingly, embolic debris cause new ischemic brain lesions in 70% of
patients post TAVI, major disabling strokes in 9%, and kidney dysfunction 12.3% of cases. Embolic Protection Devices
(EPDs) are being developed to reduce the risk posed by embolic debris during TAVI. To date, only one EPD has been
commercialised for use in TAVI procedure. Unfortunately, the device is poorly effective since it can only provide partial
cerebral protection, interferes with the TAVI delivery system, and requires secondary artery access to the TAVI system, thus
increasing procedure time and posing the patient at a higher risk of post-operative side effects.
Filterlex developed the CAPTIS® system, an innovative intra-aortic Embolic Protection Device (EPD) for deflecting,
capturing and removing embolic particles during TAVI procedure. Easily positioned, deployed and retrieved through the
same TAVI artery access, this revolutionary EPD provides full-body protection by ensuring the best performance in capturing
and safely removing the embolic debris released during TAVI. In this way, CAPTIS strongly reduces the risk of stroke and
ischemia to other vital organs.
The key objectives of the project are to validate safety and efficacy of the CAPTIS system through a First-In-Human clinical
trial and multi-site clinical trial, and to obtain CE mark certification for commercialisation in Europe.

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Topic(s)

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SME-2 - SME instrument phase 2

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Call for proposal

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(opens in new window) H2020-EIC-SMEInst-2018-2020

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Coordinator

FILTERLEX MEDICAL LTD
Net EU contribution

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.

€ 2 135 000,00
Address
OFEK NO 4 BUILDING NO 9 KHALAMISH
3089900 CAESAREA
Israel

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Total cost

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.

€ 3 050 000,00
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