Studies generate encouraging results in
advance of the STRIDE pivotal trial
BOSTON, Sept. 17,
2024 /PRNewswire/ -- CereVasc, Inc., a clinical-stage
medical device company developing novel treatments for neurological
diseases, today announced enrollment of the 50th
patient in its pilot studies of the eShunt System in patients with
Normal Pressure Hydrocephalus (NPH), in centers in the U.S. and in
Argentina.
The studies, (NCT05232838 and NCT05250505) approved by the U.S.
Food and Drug Administration (FDA) and by the National
Administration of Drugs, Food and Medical Devices (ANMAT) in
Argentina are being conducted
under the leadership of Charles
Matouk, MD, of Yale New Haven Health and Pedro Lylyk, MD, of Clinica la Sagrada Familia.
"We are thrilled to have achieved this milestone of enrolling 50
patients in our pilot studies of the eShunt System in patients with
NPH and we are very thankful for the support we have received from
our clinical investigators in achieving this level of study
enrollment," said Dan Levangie,
Chairman & CEO of CereVasc, Inc.
A key next step in the development of the eShunt System will be
the STRIDE pivotal study in patients with NPH. This
multi-center, randomized controlled trial will assess the safety
and efficacy of the eShunt System compared with the
standard-of-care ventriculo-peritoneal (VP) shunt, serving as the
basis for the company's future Premarket Approval (PMA) submission
to the FDA.
"The level of enthusiasm about the potential of the eShunt
System from physicians, patients and caregivers we have seen
throughout the pilot study provides tremendous momentum as we
initiate the STRIDE trial," continued Levangie.
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.
Media and Company Contact:
Ethan Metelenis, Precision AQ
Ethan.Metelenis@precisionaq.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/cerevasc-announces-enrollment-of-the-50th-patient-in-pilot-studies-of-the-eshunt-system-for-normal-pressure-hydrocephalus-302250068.html
SOURCE CereVasc