CereVasc Received FDA Breakthrough Device Designation eShunt® System for Pediatric Patients

CereVasc, Inc., a clinical-stage medical device company focused on developing innovative treatments for neurological conditions, has received a second Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its investigational eShunt System. This designation applies to the treatment of communicating hydrocephalus in paediatric patients aged 12 years and older.

The study, carried out at Texas Children's Hospital and Oregon Health and Sciences University, examined high-resolution brain MRI scans from two groups of 50 consecutive patients. The analysis focused on measurements of the inferior petrosal sinus and cerebellopontine angle cistern using existing anatomical standards to assess the possibility of safely implanting the eShunt System.

Findings indicated that, based on established anatomical guidelines, the endovascular placement of the device was feasible in 67% of the 100 patients reviewed. Furthermore, there were no statistically significant differences in anatomical eligibility based on age. Most children over the age of one met the criteria for eShunt implantation.

The Breakthrough Device Designation allows for priority review and increased interaction with the FDA during the regulatory and clinical trial process for the paediatric application of the eShunt System.