CereVasc’s eShunt Wins FDA Breakthrough Status for Pediatric Use
In a significant breakthrough in the field of medical technology, CereVasc has received its second FDA Breakthrough Device Designation for its eShunt System. This innovative device is now poised to treat communicating hydrocephalus in pediatric patients aged 12 and above. The designation, granted by the US Food and Drug Administration (FDA), is a testament to the device’s potential to significantly improve patient outcomes and reduce the burden of this debilitating condition.
Communicating hydrocephalus is a complex condition characterized by the accumulation of cerebrospinal fluid (CSF) in the brain, leading to increased intracranial pressure and potentially life-threatening consequences. Current treatment options, such as shunting, carry significant risks and complications, including infection, malfunction, and cognitive impairment. The eShunt System, with its minimally invasive approach, offers a promising alternative to traditional treatments.
The eShunt System has already demonstrated impressive results in adult patients, with a pilot study showing 67% placement feasibility and 97% symptom improvement. These findings, backed by clinical research, have paved the way for the device’s pediatric indication. The Breakthrough Device Designation enables faster FDA review for the device, which is designed to reduce the risk of complications and improve patient outcomes.
“We are thrilled to receive this Breakthrough Device Designation for the pediatric use of our eShunt System,” said Dr. Daniel Costa, CEO of CereVasc. “This achievement recognizes the potential of our technology to transform the treatment of communicating hydrocephalus in pediatric patients. We are committed to bringing this innovative solution to market as quickly as possible, with the goal of improving the lives of patients and their families.”
The eShunt System is a revolutionary device that uses a minimally invasive approach to treat communicating hydrocephalus. The device consists of a small, implantable stimulator that is placed in the brain, which then stimulates the CSF flow and helps to reduce the accumulation of fluid. This non-invasive treatment offers several advantages over traditional shunting, including reduced risk of infection, lower risk of complications, and improved patient outcomes.
The Breakthrough Device Designation is a significant milestone for CereVasc, marking the second time the company has received this prestigious designation. The first Breakthrough Device Designation was awarded to the eShunt System for its adult indication, highlighting the device’s potential to revolutionize the treatment of communicating hydrocephalus in adults.
The FDA Breakthrough Device Designation is granted to devices that demonstrate significant potential to improve patient outcomes or reduce the risk of serious complications. The designation provides a faster review process for the device, allowing it to reach the market more quickly.
The eShunt System is currently undergoing clinical trials, with results expected in the near future. The Breakthrough Device Designation is a significant step towards the device’s approval and commercialization, paving the way for its use in pediatric patients.
In conclusion, the FDA Breakthrough Device Designation for CereVasc’s eShunt System is a significant milestone in the development of a minimally invasive treatment for communicating hydrocephalus in pediatric patients. With its impressive results in adult patients and promising clinical data, the eShunt System has the potential to revolutionize the treatment of this debilitating condition. As the device moves towards commercialization, it is poised to make a significant impact on the lives of patients and their families.
