CereVasc, Inc. Receives FDA Breakthrough Device Designation for the eShunt® System for Use in Pediatric Patients

CereVasc, Inc. Receives FDA Breakthrough Device Designation for the eShunt® System for Use in Pediatric Patients

/PRNewswire/ -- CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, today announced it has received...

CereVasc eShunt Receives Breakthrough Device Designation for Use in Pediatric Patients to Treat Communicating Hydrocephalus - Endovascular Today

April 23, 2025—CereVasc, Inc. announced it has received its second FDA Breakthrough Device designation for the investigational eShunt system. This designation is for use in the treatment of communicating hydrocephalus in pediatric patients aged ≥ 12 years. The designation will enable priority review and enhanced communication with the FDA during the clinical trial and regulatory review process for a pediatric indication for the eShunt system, no…

CereVasc Inc. Receives FDA Breakthrough Device Designation

CereVasc Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, has received its second Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its investigational eShunt System. This Breakthrough Device Designation is for the treatment of communicating hydrocephalus in pediatric patients aged 12 and older. The Breakthrough Device Designation was supported by data genera…

CereVasc's EShunt® System Gains FDA Breakthrough Designation

"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 availabl…