CereVasc has announced that the US Food and Drug Administration (FDA) has approved its investigational device exemption (IDE) application to initiate a pilot trial of the eShunt system in patients with normal-pressure hydrocephalus (NPH).
“This is a very important stage in the ongoing development of this technology. We are committed to continuing the development of this alternative to conventional shunting for the thousands of patients suffering from disabling effects of NPH and other forms of adult hydrocephalus,” said Carl Heilman, neurosurgeon-in-chief and chairman of neurosurgery at Tufts Medical Center in Boston, USA.
Representing the first minimally invasive treatment for NPH, the eShunt device offers the potential to result in benefits over the current treatment—a half-century old neurosurgical procedure associated with frequent failure, infection risk and high costs. This is according to a CereVasc press release.
“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,” said Dan Levangie, chairman and CEO of CereVasc. “It is 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.”