2.5M patients per year in the US and the EU require pericardial space access as the result of a variety of pathological conditions. Atrial Fibrillation (AF) is the most common condition requiring pericardial access, in fact, AF affected 24M people in the US and 11M in the EU (2016). In current epicardial access techniques (using needles), complications can reach 4.5-30% (representing a ˞€600M/year increase in costs for healthcare systems) and includes heart puncture, cardiac tamponade and pericardial bleeding, which can result in an increase in patient deaths. The use of a needle in the heart area, which is in constant motion, requires a high level of skill and expertise during surgery.
EpiVIASYSTEM is the first device (PCT /IL2018 /050670) to ensure pericardial access in a confident, safe, needle-free manner avoiding complications during penetration of the pericardium. The device employs a unique geometrically structured thread that ensures a secure workspace for the use of additional cardiovascular devices, such as mapping and ablation catheters for treatment of arrhythmia disorders. Its design will ensure a competitive price of €250/procedure when compared with €130 for the equivalent tools used in invasive non-electrohpysiological procedures. EpiVIASYSTEM is expected to improve clinical outcomes of patients and reduce costs associated with failed ablations associated with the needle use by €600M/year. The increased growth of cardiac pathologies and the 2.5M of patients/year that require pericardial access represent a big business opportunity for the EpiVIASYSTEM and will favour its successful market uptake.
EpiVIASYSTEM´s main objective is to optimize, scale-up and commercialize a marketable medical device in both the EU and the US by 2021. For that, a feasibility study will be performed during SME Phase 1 to evaluate any technical, commercial and/or financial issues and ensure the successful release of the EpiVIASYSTEM into the market.
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