CereVasc Launches Groundbreaking Clinical Trial in Argentina for Innovative NPH Treatment
February 13, 2025: CereVasc, Inc., a Boston-based medical device company, has received approval from Argentina's National Administration of Drugs, Food and Medical Devices (ANMAT) to initiate the STRIDE clinical trial for their revolutionary eShunt® System2. This innovative device aims to treat normal pressure hydrocephalus (NPH) in elderly patients, offering a minimally invasive alternative to traditional surgical methods2.
Trial Details
The STRIDE trial will evaluate the safety and effectiveness of the eShunt System compared to the current standard of care, the ventriculo-peritoneal (VP) shunt2. This study marks a significant milestone in NPH treatment, as the eShunt System is the first new treatment option developed for this condition in over 60 years2.
Importance for Latin American Clinical Research
CereVasc's decision to conduct this pivotal study in Argentina underscores the growing importance of Latin America as a destination for cutting-edge medical device clinical trials. As the leading Medtech contract research organization (CRO) in Latin America, bioaccess® is uniquely positioned to support innovative companies like CereVasc in their clinical research endeavors throughout the region.
bioaccess®: Your Partner for Latin American Clinical Trials
bioaccess® stands out as the only Medtech CRO in Latin America specializing in helping Medtech startups conduct their first-in-human studies in Argentina and other Latin American countries. Our expertise and regional knowledge make us the ideal partner for companies looking to leverage the benefits of conducting clinical trials in this dynamic and promising market.
Potential Impact
Dr. Pedro Lylyk, CEO of ENERI and Clinica la Sagrada Familia in Buenos Aires and co-lead investigator of the STRIDE trial, emphasized the potential impact of this study: "Positive findings from the STRIDE trial will broaden access to NPH treatment in Argentina, as more patients would likely be eligible for a minimally invasive procedure than for open brain surgery"2.The successful launch of the STRIDE trial in Argentina represents a significant step forward in CereVasc's mission to improve the quality of life for people affected by NPH worldwide2. It also highlights the growing role of Latin America in advancing global medical device innovation and clinical research.
