CereVasc Announces First Enrollment in STRIDE Clinical Trial of the eShunt® System for Normal Pressure Hydrocephalus

Clinical trial site locations in the United States and around the world are beginning to recruit patients

BOSTON, Jan. 14, 2025 /PRNewswire/ -- CereVasc, Inc., a clinical-stage medical device company developing novel treatments for neurological diseases, today announced the first enrollment of a patient in the STRIDE clinical trial of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH).

The STRIDE trial is a multi-center, randomized controlled study that will assess the safety and efficacy of the eShunt System compared with the standard-of-care ventriculo-peritoneal (VP) shunt in the treatment of elderly patients diagnosed with normal pressure hydrocephalus, also known as Hakim's Disease. The results of the STRIDE trial will serve as the basis for the company's future Premarket Approval (PMA) submission to the FDA. Trial site locations exist throughout the United States and around the world.

"The groundswell of excitement amongst patients and in the medical community is a true testament to the need for innovation in treating these patients," said Charles Matouk, M.D., a professor of neurosurgery at Yale School of Medicine and a lead investigator of the STRIDE study. "Fear of conventional open neurosurgery is common, and patients are enthusiastic about the prospect of receiving safe and effective treatment for NPH in a minimally invasive way. The eShunt System could dramatically improve quality of life for older people living with this disease."

The eShunt System is the only endovascular shunt and the first new treatment option developed for NPH since VP shunts were introduced more than 70 years ago. Roughly 800,000 people in the US alone suffer from NPH, many of whom are deemed poor candidates for surgical intervention using the VP shunt due to age, frailty and the high complication rate. 

"The eShunt System is helping to usher in a new era in neurosurgery for shorter, less invasive procedures that foster patient eligibility and willingness to undergo treatment," said co-lead investigator Dr. Pedro Lylyk, M.D., a neurosurgeon with Clinica la Sagrada Familia in Argentina. "With its potential to improve safety and reduce recovery time in those being treated for NPH, CereVasc's technology could change the standard of care for this common neurological disease."

"STRIDE is the first trial to directly compare a less invasive alternative with the traditional surgical treatment for treatment of NPH, ventriculoperitoneal shunting," said Dan Levangie, CereVasc Chairman & CEO. "Opening of enrollment into this unique study is a key milestone, both for CereVasc and for patients with NPH who seek minimally invasive procedure intended to treat a progressive, life-threatening form of communicating hydrocephalus." 

For more information, please visit https://nphstridestudy.com/.

About CereVasc, Inc.
Located in Massachusetts' healthcare hub, CereVasc, Inc., is a clinical stage, medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, encompasses first-ever, groundbreaking percutaneous transvenous-transdural access to the central nervous system intended to allow the first minimally invasive treatment for communicating hydrocephalus (CH). The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon-in-Chief and Chair of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Endovascular Neurosurgery. The patented eShunt System includes an endovascularly implantable cerebral spinal fluid shunt and delivery components, which are designed to treat CH without invasive surgery. For additional information, please visit our website at www.cerevasc.com.

The eShunt^® Device is an investigational device and not available for sale within or outside the United States.

Company Contact:
DJ Cass
CereVasc, Inc.
[email protected]

Media Contacts:
Ethan Metelenis, Precision AQ
[email protected]

Christina Renfroe, Precision AQ
[email protected]

SOURCE CereVasc