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.
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.
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Programme(s)
Funding Scheme
SME-2 - SME instrument phase 2Coordinator
3089900 CAESAREA
Israel
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.