A novel embolic protection device: preclinical feasibility studies

Problem and Opportunity: Oral anticoagulants (OACs) decreases the risk of stroke by two-thirds, but efficacy is jeopardized in non-compliant patients. Also, it is unsuitable for AF patients with recent or active bleeding. LAAO was introduced as an alternative stroke prophylaxis for AF patients who cannot take OACs. Yet, LAAO closure devices cannot prevent embolic strokes from other origins and therefore, are not suitable for all patients. In addition, they are contraindicated for cases where thrombi were detected in the LAA.

Product Concept: Our aim was to develop an alternative approach to stroke prevention in high-risk patients (AF, valvular lesions and ventricular thrombi). To this end, we designed a specialized intra-aortic apparatus that can divert embolic particles, without adversely affecting cerebral flow and perfusion pressure. The intravascular device is composed of an expandable, flexible stent and a filtering component. Safety and efficacy were demonstrated in a swine model.

Medical Significance: We hypothesize that implantation of such a specialized apparatus into the aortic arch will provide continuous protection to all cerebral branches, regardless of embolic source. This approach could be used for millions of patients who cannot withstand pharmacological interventions or unsuitable for LAAO.

Target Markets: In the USA alone, about 795,000 people experience a new or recurrent stroke annually. Many survivors live with long-term impairments that require costly, specialized care. The population at-risk for stroke is projected to increase each year. Global market of OACs is expected to reach $43.6 billion by 2025 and the LAAO device market is anticipated to reach ~$1 billion.

Team: InVatin Technologies Ltd was founded by Udi Nussinovitch, MD, PhD and is managed together with Elon Reshef, DVM. Both Udi and Elon share a long-term experience in leading innovative research and development projects, conducting animal studies, as well as profound knowledge of industrial regulations.