Cerevasc has announced the first enrolment of a patient in the STRIDE clinical trial evaluating the company’s eShunt system in patients with normal-pressure hydrocephalus (NPH).
The STRIDE trial is a multicentre randomised controlled study that will assess the safety and efficacy of the eShunt system compared with the standard-of-care ventriculoperitoneal (VP) shunt in the treatment of elderly patients diagnosed with NPH—also known as Hakim’s disease.
STRIDE site locations exist throughout the USA and around the world, and results of the trial will serve as the basis for the company’s future premarket approval (PMA) submission to the US Food and Drug Administration (FDA).
“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 (Yale School of Medicine, New Haven, USA), 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.”
Cerevasc claims that 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. In a press release, the company also states that, while 800,000 people in the USA alone suffer from NPH, many are deemed poor candidates for surgical intervention using the VP shunt due to age, frailty and high complication rates.
“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 Pedro Lylyk (Clinica la Sagrada Familia, Buenos Aires, 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 […] NPH—ventriculoperitoneal shunting,” said Dan Levangie, Cerevasc chairman and chief executive officer (CEO). “Opening of enrolment into this unique study is a key milestone, both for Cerevasc and for patients with NPH who seek minimally invasive procedures intended to treat a progressive, life-threatening form of communicating hydrocephalus.”
