CereVasc’s eShunt® Wins FDA Breakthrough Status for Pediatric Use
CereVasc has received its second FDA Breakthrough Device Designation for its eShunt System, now aimed at treating communicating hydrocephalus in pediatric patients aged 12+. Backed by pilot study data and clinical research, the device showed 67% placement feasibility and 97% symptom improvement in adults. The designation enables faster FDA review for this minimally invasive treatment.