FDA approves IDE for study of normal pressure hydrocephalus treatment

The FDA has granted investigational device exemption to clinical-stage medical device company CereVasc for a pilot trial of its eShunt System in patients with normal pressure hydrocephalus.

According to a company press release, the device is the first minimally invasive treatment for normal pressure hydrocephalus (NPH) and may outperform the current intervention, a neurosurgical procedure linked to frequent failure, infection risk and high costs.

"We are delighted the FDA has granted this IDE allowing CereVasc to commence an initial clinical study evaluating the use of the eShunt System in patients with NPH, a disorder estimated to affect more than 700,000 Americans," Dan Levangie, chairman and CEO of CereVasc, said in the release. "It's an exciting and important milestone for CereVasc and we look forward to working closely with the study investigators to evaluate a new treatment option with the potential to benefit thousands of elderly hydrocephalus patients."