Medical device and MedTech insights, news, tips and more

CereVasc Announces FDA Approval of Second IDE Study of the eShunt® System

August 29, 2022

CereVasc-eShunt

CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt® System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). 

“We are excited to receive IDE approval from FDA to conduct a second pilot study in the US of the eShunt System in patients who develop hydrocephalus following subarachnoid hemorrhage. Enrolling in parallel with our first IDE study in patients with Normal Pressure Hydrocephalus (NPH), this study will allow us to further examine the safety and efficacy of the eShunt System in a second etiology of hydrocephalus, both of which present a number of management challenges to physicians,” said Dan Levangie, Chairman and CEO of CereVasc.

“Reports in the literature document that chronic hydrocephalus occurs in 9% to 48% of patients with paSAH. We believe we can have a beneficial impact in how these patients are treated by offering a minimally invasive alternative to current treatments,” continued Levangie.

“Considering the encouraging results from our first-in-human study of the eShunt System in Argentina in patients with hydrocephalus secondary to subarachnoid hemorrhage, we are eager to study the same patient population in the US,” said Adel Malek, MD, PhD, Neurosurgeon and Chief of Neurovascular Surgery at Tufts Medical Center, Boston.

Details on the trial will soon be posted to www.clinicaltrials.gov.

About CereVasc, Inc.

Located in Massachusetts’ healthcare hub, CereVasc, Inc., is a clinical-stage, venture-funded, medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. Its flagship product, the eShunt System, is intended to offer the first minimally invasive treatment for communicating hydrocephalus (CH) and an improvement to the current standard of care. The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon-in-Chief and Chairman of Neurosurgery, and Adel Malek, MD, PhD, Neurosurgeon and Chief of Neurovascular Surgery. The patented eShunt System includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components, which are designed to treat CH without invasive surgery. For additional information, please visit our website at www.cerevasc.com.

See Full Press Release at the Source: CereVasc Announces FDA Approval of Second IDE Study of the eShunt® System


Press Release by: CereVasc


Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.

Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.

More insights

March 7, 2024
FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor
Learn More
March 1, 2024
FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis
Learn More
February 21, 2024
Sparrow BioAcoustics Launches Software That Turns a Smartphone into a Stethoscope 
Learn More

Begin your legacy now. We are your medtech and medical device talent advisory firm.