#United States #Massachusetts #CereVasc #eShunt #NPH

CereVasc Launches STRIDE Clinical Trial for eShunt System

CereVasc, Inc., a pioneering medical device company focused on developing cutting-edge therapies for neurological conditions, announced the initiation of patient enrollment in the STRIDE clinical trial. This clinical study will spotlight the eShunt System as a promising treatment option for individuals diagnosed with Normal Pressure Hydrocephalus (NPH), a condition often debilitating to its sufferers.

Overview of the STRIDE Trial and Its Significance

The STRIDE trial is structured as a multi-center, randomized controlled study. Its objective is to appraise the safety and efficacy of the eShunt System against the conventional treatment—ventriculo-peritoneal (VP) shunt surgery. This trial holds particular significance as it addresses the needs of elderly patients diagnosed with NPH, also recognized as Hakim's disease, where conventional surgical interventions are often fraught with complications.

Dr. Charles Matouk, a professor of neurosurgery at Yale School of Medicine and leading investigator on the STRIDE study, expressed a sentiment prevalent among both patients and the medical community: a pressing need for innovative treatment modalities for NPH. According to Dr. Matouk, "The groundswell of excitement among patients reflects the dire necessity for innovative solutions in managing this condition. The fear associated with traditional open neurosurgery is common, and the possibility of safe, minimally invasive treatments is met with enthusiasm."

eShunt System: A Paradigm Shift in Treatment

The eShunt System is noteworthy for being the first endovascular shunt developed for the treatment of NPH in over 70 years, marking a significant milestone in neurosurgery. It aims to resolve the treatment gap for approximately 800,000 individuals in the U.S. suffering from this condition, many of whom face risks that render them unsuitable for traditional surgical options.

Dr. Pedro Lylyk, another co-lead investigator and a neurosurgeon practicing in Argentina, emphasized the potential impact of the eShunt System in enhancing patient safety and reducing recovery times. He noted, "The eShunt System is ushering in a transformative era of less invasive surgical procedures that could significantly increase patient willingness to undergo treatments that were previously seen as high-risk."

The Promise of STRIDE

Dan Levangie, the Chairman CEO of CereVasc, stated that STRIDE is the first trial explicitly intended to compare a less invasive treatment alternative against the established surgical method—ventriculoperitoneal shunting. He underscored the importance of this trial's commencement as a pivotal moment for both the company and patients battling NPH.

"The initiation of enrollment is not only a landmark for CereVasc but also for patients yearning for minimally invasive procedures that can address this progressive, life-threatening condition," said Levangie.

Conclusion and Further Information

The STRIDE clinical trial represents a beacon of hope for individuals living with NPH as it seeks to redefine standards of care through innovative treatment solutions. For ongoing updates regarding the trial and its progress, interested parties can visit nphstridestudy.com.

CereVasc, situated in Massachusetts' medical hub, is at the forefront of developing minimally invasive neurological treatments. Its eShunt System exemplifies groundbreaking progress in addressing the treatment needs of patients facing neurological challenges. With an aim to revolutionize treatment options, the achievements from the STRIDE trial could signal a new path for patients contending with NPH.

Note: The eShunt device is currently investigational and not yet available for commercial sale either in the U.S. or internationally.