CereVasc announced today that it received FDA breakthrough device designation for its investigational eShunt system.
The breakthrough nod marks Boston-based CereVasc’s second for eShunt. It covers the treatment of communicating hydrocephalus in pediatric patients aged 12 and older.
eShunt received its initial FDA breakthrough device designation last August. Last May, the company received the FDA’s go-ahead to begin its STRIDE pivotal study under IDE. Earlier this year, the company initiated that trial. It plans to use findings to support an FDA submission down the line.
CereVasc designed eShunt for treating NPH. eShunt offers a minimally invasive endovascular treatment option with potential benefits, CereVasc says. It includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components. Those delivery components include a self-expanding nitinol anchor.
Data collected in pilot clinical studies of the device found feasibility for endovascular shunt placement in 67% of 100 pediatric patients. The company reports no statistically significant age-based differences in eligibility. Ultimately, the majority of patients over one year of age met the anatomical criteria for eShunt placement.
CereVasc said the breakthrough nod enables priority review and enhanced communication with the FDA as it looks to bring eShunt to market.
“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, CereVasc chair & CEO.
