CereVasc Receives Approval for Pilot Study of eShunt to Treat Normal Pressure Hydrocephalus

February 8, 2022—CereVasc, Inc. announced that the FDA has approved an investigational device exemption application to initiate a pilot trial of the company’s eShunt system in patients with normal pressure hydrocephalus (NPH). CereVasc advised that details on the trial will soon be posted to www.clinicaltrials.gov.

According to the company, the eShunt device offers a minimally invasive treatment for NPH that has the potential to result in greater benefits versus the current treatment, a neurosurgical procedure associated with frequent failure, infection risk, and high costs.

The system includes an endovascularly implantable cerebral spinal fluid shunt and CereVasc’s delivery components, which are designed to treat communicating hydrocephalus without invasive surgery. The eShunt device is an investigational device and not available for sale within or outside the United States, advised CereVasc.

The company noted that the eShunt device concept originated from Carl Heilman, MD, and Adel Malek, MD. Both are with Tufts Medical Center in Boston, Massachusetts, where Dr. Heilman is Neurosurgeon-in-Chief and Chairman of Neurosurgery and Dr. Malek is a neurosurgeon and Chief of Neurovascular Surgery.

“This is a very important stage in the ongoing development of this technology,” commented Dr. Heilman in the company’s press release. “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.”

Diana Gray, President and CEO of the Hydrocephalus Association, added in the company’s announcement, “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. There is currently a great deal of interest in the diagnosis and management of NPH, with the expectation that the reported incidence of this condition will increase dramatically with the aging of the population.”