Latest news with #CereVasc
Yahoo
30-07-2025
- Health
- Yahoo
CereVasc, Inc. Announces 100th Patient Treated with the eShunt® System
Patient treated at Clinica la Sagrada Familia in Buenos Aires, Argentina BOSTON, July 30, 2025 /PRNewswire/ -- CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, today announced that the 100th patient has received treatment for communicating hydrocephalus with the eShunt System. The 100 patients were enrolled in pilot studies and in the STRIDE clinical trial, a head-to-head comparison of the eShunt System versus the standard of care ventriculo-peritoneal (VP) shunt in patients with Normal Pressure Hydrocephalus (NPH). The 100th patient was treated by Dr. Pedro Lylyk at Clinica la Sagrada Familia in Buenos Aires, Argentina. Dr. Lylyk also treated the first patient with the eShunt System. "I am honored to have performed the 100th procedure utilizing the eShunt System for patients with communicating hydrocephalus," said Pedro Lylyk, M.D., CEO of ENERI and Clinica la Sagrada Familia in Buenos Aires and co-lead investigator of the STRIDE trial. "The minimally invasive procedure will help ensure more patients with hydrocephalus are eligible for treatment." The eShunt System is the first and only minimally invasive, endovascular shunt and the first new treatment option developed for communicating hydrocephalus since the VP shunt was introduced more than 60 years ago. The results of the STRIDE trial will serve as the basis for CereVasc's anticipated submission to regulatory agencies for approval to market the eShunt System. "Reaching this milestone was made possible through the support of clinical investigators like Dr. Lylyk, who have demonstrated their commitment to driving innovation and improving patient care," said Dan Levangie, Chairman & CEO of CereVasc, Inc. "We are incredibly fortunate to work with Dr. Lylyk and his outstanding team in Buenos Aires and are excited by the enthusiastic response of the medical community for the eShunt System. Enrollment in our STRIDE pivotal trial is off to a strong start and we look forward to completing this landmark clinical study." For more information, please visit About Normal Pressure Hydrocephalus Normal pressure hydrocephalus (NPH) is most commonly seen in adults aged 60 or over. The Hydrocephalus Association estimates that 800,000 older Americans may be living with NPH, and it is estimated that more than 80% of cases remain unrecognized or untreated. Without appropriate diagnostic testing, NPH is often misdiagnosed as Alzheimer's disease or Parkinson's disease, the result of a stroke, or other neurodegenerative conditions. Sometimes the symptoms are mistakenly attributed to "normal aging." NPH is, however, one of the few treatable forms of dementia. 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 enable the first minimally invasive treatment for communicating hydrocephalus (CH). The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon and Chair Emeritus of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Cerebrovascular and 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 The eShunt® Device is an investigational device and has not been approved by FDA or any other regulatory agency for commercial sale. Its safety and effectiveness have not yet been fully established. Company Contact: DJ CassCereVasc, Media Contacts: Ethan MetelenisPrecision Christina RenfroePrecision View original content to download multimedia: SOURCE CereVasc Sign in to access your portfolio
Yahoo
18-06-2025
- Health
- Yahoo
CereVasc Receives Health Canada Investigational Testing Authorization for STRIDE Clinical Trial of the eShunt® System
The STRIDE trial is actively enrolling at multiple sites in the United States and Argentina for the treatment of elderly patients with Normal Pressure Hydrocephalus (NPH) BOSTON, June 18, 2025 /PRNewswire/ -- CereVasc, Inc., a clinical-stage medical device company developing novel treatments for neurological diseases, announced today that it has received Investigational Testing Authorization (ITA) from Health Canada to conduct the STRIDE trial, a clinical study evaluating CereVasc's eShunt System as a treatment for normal pressure hydrocephalus (NPH). The trial will evaluate the safety and effectiveness of the eShunt System versus the current standard of care, the ventriculo-peritoneal (VP) shunt, in draining accumulated cerebrospinal fluid from the brain in elderly patients. The results of the STRIDE trial will serve as the basis for CereVasc's anticipated submission to regulatory agencies for approval to market the eShunt System. "A minimally invasive, endovascular approach to treating NPH has the potential to improve recovery times and reduce the possibility of post-operative complications for patients living with this progressive, neurological condition," said Dr. Vitor Mendes Pereira, Neurosurgeon and Director of Endovascular Research and Innovation at St. Michael's Hospital. "I am encouraged by initial study results of the eShunt System and look forward to participating in the STRIDE trial, with the goal of improving care and clinical outcomes for patients." The eShunt System is the only minimally invasive, endovascular shunt and the first new treatment option developed for NPH since the VP shunt was introduced more than 60 years ago. "This marks another important milestone for patients and caregivers living with NPH, as the eShunt System is designed to make treatment accessible for more patients while potentially improving outcomes," stated Dan Levangie, Chairman and CEO of CereVasc. "Authorization from Health Canada for the STRIDE clinical trial brings us closer to our mission of improving the quality of life globally for people living with this debilitating neurological condition." For more information, please visit 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 enable the first minimally invasive treatment for communicating hydrocephalus (CH). The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon and Chair Emeritus of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Cerebrovascular and 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 The eShunt® Device is an investigational device and has not been approved by FDA or any other regulatory agency for commercial sale. Its safety and effectiveness have not yet been fully established. Company Contacts: DJ CassCereVasc, Media Contacts: Ethan MetelenisPrecision Christina RenfroePrecision View original content to download multimedia: SOURCE CereVasc Sign in to access your portfolio
Associated Press
25-02-2025
- Health
- Associated Press
CereVasc Announces First Patient Randomized to eShunt® System Treatment in STRIDE Pivotal Trial
Patient treated at VCU Health BOSTON, Feb. 25, 2025 /PRNewswire/ -- CereVasc, Inc., a clinical-stage medical device company developing novel treatments for neurological diseases, announced today that the first patient has been randomized to and treated with the eShunt® System in its STRIDE clinical trial, a head-to-head comparison of the novel eShunt System versus the standard of care ventriculo-peritoneal (VP) shunt in patients with normal pressure hydrocephalus (NPH). The patient was treated at VCU Health in Richmond. Multiple trial site locations are now open across the United States. STRIDE is a multi-center, randomized, controlled trial designed to assess the safety and efficacy of the eShunt System compared with the current standard of care, the VP shunt, in elderly patients diagnosed with NPH. The results of the STRIDE trial will serve as the basis for CereVasc's anticipated Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA). NPH is a life-threatening form of communicating hydrocephalus that affects 800,000 people in the United States alone. 'I was honored to perform the inaugural treatment in the STRIDE trial. This investigation could lead to a safer and less invasive way to address the gait disturbance, cognitive deficits, and urinary incontinence that are experienced by people with NPH,' said John Reavey-Cantwell, M.D., Neurosurgeon and Director of Cerebrovascular and Endovascular Neurosurgery at VCU Health. 'Because the eShunt System is less invasive than the VP shunt, this trial will assess its potential to improve recovery times and reduce post-operative complications such as infection. As a result, I'm hopeful it will make treatment possible for more patients living with this devastating neurological disease — including those who have comorbidities.' The eShunt System is the only endovascular shunt and the first new treatment option developed for NPH since the standard of care was introduced more than 60 years ago. 'The treatment of the first patient with the eShunt® System in the STRIDE trial marks an important milestone for CereVasc by providing a potential new treatment option for patients with NPH and for the medical community, which has expressed considerable enthusiasm about the promise of the eShunt System,' said Dan Levangie, CereVasc's Chairman & CEO. 'As the first randomized controlled trial comparing a modern alternative with the standard-of-care treatment for NPH, this trial is an important step in evaluating the safety and effectiveness of the eShunt System. This trial could provide a way for elderly patients with NPH to improve their quality of life while supporting an overall movement toward minimally invasive procedures across the field of neurosurgery.' For more information, please visit 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 and Chair Emeritus of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Cerebrovascular and 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 The eShunt® Device is an investigational device and has not been approved by FDA or any other regulatory agency for commercial sale. Its safety and effectiveness have not yet been fully established. Company Contact: DJ Cass CereVasc, Inc. Media Contacts: Ethan Metelenis Precision AQ
Yahoo
13-02-2025
- Health
- Yahoo
CereVasc Receives Approval for STRIDE Clinical Trial of the eShunt® System for the Treatment of Elderly Patients with Normal Pressure Hydrocephalus in Argentina
With approval from ANMAT, CereVasc has initiated enrollment of the STRIDE trial in Argentina BOSTON, Feb. 13, 2025 /PRNewswire/ -- CereVasc, Inc., a clinical-stage medical device company developing novel treatments for neurological diseases, announced today that it has received approval from Argentina's National Administration of Drugs, Food and Medical Devices (ANMAT) to initiate the STRIDE trial, a clinical study evaluating CereVasc's eShunt System as a treatment for normal pressure hydrocephalus (NPH). The trial will evaluate the safety and effectiveness of the eShunt System versus the current standard of care, the ventriculo-peritoneal (VP) shunt, in draining accumulated cerebrospinal fluid from the brain in elderly patients. The results of the STRIDE trial will serve as the basis for CereVasc's anticipated submission to regulatory agencies for approval to market the eShunt System. "Treatment is essential for patients with NPH, as this progressive, life-threatening form of communicating hydrocephalus can cause symptoms including cognitive dysfunction, gait disturbance and urinary incontinence," said Pedro Lylyk, M.D., CEO of ENERI and Clinica la Sagrada Familia in Buenos Aires and co-lead investigator of the STRIDE trial. "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." The eShunt System is the only minimally invasive, endovascular shunt and the first new treatment option developed for NPH since the VP shunt was introduced more than 60 years ago. "We're pleased that ANMAT has approved this study, enabling us to move closer to a new standard in NPH treatment designed to reduce recovery time and complications for patients," said Dan Levangie, Chairman and CEO of CereVasc. "The launch of the STRIDE trial in Argentina represents a key milestone in CereVasc's mission to improve the quality of life for people around the world who are affected by this devastating neurological condition." For more information, please visit About CereVasc, 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 and Chair Emeritus of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Cerebrovascular and 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 The eShunt® Device is an investigational device and has not been approved by FDA or any other regulatory agency for commercial sale. Its safety and effectiveness have not yet been fully established. Company Contacts: DJ CassCereVasc, Media Contacts: Ethan MetelenisPrecision Christina RenfroePrecision View original content to download multimedia: SOURCE CereVasc
