The acute aortic valve stenosis is an abnormal constriction of the aortic valve, which strongly reduces the oxygenated blood flow from the heart to the systemic circulation. It is one of the most commonly observed heart valve diseases and is typically treated with an aortic valve replacement.

Heart valves were conventionally replaced by open-heart surgeries. However, for older patients this procedure comes with a high risk of mortality. Therefore, these patients are currently treated by transcatheter aortic valve implantation (TAVI) which is a comparatively easy and secure minimally invasive alternative. This procedure results in shorter operation durations as well as faster recovery which is why it is also increasingly used for patients with a lower operation risk.

Nevertheless, for each TAVI procedure there is a risk of thrombosis and displacement of small particles, which are known to cause strokes.

Strokes remain one of the main causes for permanent disabilities for adults as well as being the second leading cause for dementia. Silent strokes can be triggered by cerebral micro embolic events. In most cases, small brain lesions occur during or after TAVI treatments.

The frequency of neurologic complications following TAVI treatments shows the need for prevention measures to increase the safety of patients.

Aim of project

The development of the novel embolic protection device, the ProtEmbo device, is expected to minimize neurological complications during TAVI.

The novel protection system is expected to protect the cerebral brain system from calcific or thrombotic material and therefore significantly minimize the risk of stroke.

  Figure 1: ProtEmbo Device  

According to the future approval procedure by the Protembis GmbH commercial medical grade materials will be used for the development. Radiopaque markers will ensure the visualization and a save guidance as well as the repositioning within the aortic arch, if needed. Additionally, the design of device is optimized by an extensive study of anatomies to provide optimal treatment for a large pool of patients.

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Funding: Federal ministry of education and research, support code 13GW0058B
Cooperation partner Protembis GmbH