"The recognition of Breakthrough Device Designation for the eShunt System in pediatric aged patients demonstrates the profound need for treatment innovation in this patient population and reinforces the potential safety and efficacy benefits that have already been observed with this minimally invasive, endovascular approach," said Dan Levangie, Chairman & CEO of CereVasc, Inc. "We are encouraged and committed to making the eShunt System available to as many patients as possible living with this debilitating disease."