CereVasc today announced that it received an FDA investigational device exemption approval to begin a trial of the eShunt for normal pressure hydrocephalus.
The Boston-based company can initiate its pilot trial of the eShunt system in patients with normal pressure hydrocephalus (NPH). The eShunt device offers a minimally invasive treatment with the potential to result in benefits over the current gold-standard treatment.
“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. 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,” CEO Dan Levangie said in a news release.
Current treatment for hydrocephalus requires an invasive neurosurgical procedure, according to CereVasc. The company designed the device with an endovascularly implantable CSF count and associated delivery components that avoid the need for invasive surgery, general anesthesia, extended hospitalization and post-procedure pain management.
“We are excited about innovative therapies and the possibility of a minimally invasive treatment option for the management of hydrocephalus. This important trial could potentially benefit so many elderly patients disabled by this common neurologic disorder,” Hydrocephalus Association president and CEO Diana Gray said.