CereVasc Announces First Enrollment in STRIDE Clinical Trial for Normal Pressure Hydrocephalus

CereVasc, a clinical-stage medical device company developing treatments for neurological diseases, announced the first patient enrollment in the STRIDE clinical trial of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH).

The STRIDE trial is a multicenter, 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 NPH, also known as Hakim’s 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.” 

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 eShunt System is the only endovascular shunt and the first new treatment option developed for NPH since VP shunts were introduced over 70 years ago.

“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.”