• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » CereVasc wins FDA IDE to expand eShunt trial

CereVasc wins FDA IDE to expand eShunt trial

September 18, 2023 By Sean Whooley

cerevasc eshuntCereVasc announced today that the FDA approved an investigational device exemption (IDE) supplement for a study of its eShunt system.

The FDA permitted the expansion of the study for patients with normal pressure hydrocephalus (NPH) to additional participants and sites. The company initiated the pilot study of its eShunt system under IDE in August 2022.

Boston-based CereVasc said the supplement also allows for the use of the next-generation eShunt system in the NPH study. The company designed the system to simplify the device preparation process and enhance overall ease of use while maintaining performance.

eShunt offers a minimally invasive treatment with the potential to result in benefits over the current gold-standard treatment, according to CereVasc. It includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components.

“The early results we have seen in our pilot study of the eShunt System in treating patients with iNPH have been positive and we could not be more excited about the opportunity to have Generation 2 of the eShunt System evaluated in an expanded NPH pilot study in the US”, said Dan Levangie, CereVasc president & CEO. “Our development team has thoughtfully incorporated feedback from our study investigators and our collaborators, Dr. Pedro Lylyk, Dr. Carl Heilman, and Dr. Adel Malek, to improve the usability of the system without compromising functionality or patient safety and are looking forward to its use in the study.”

Filed Under: Food & Drug Administration (FDA), Implants, News Well, Regulatory/Compliance, Vascular Tagged With: cerevasc, FDA

More recent news

  • Real-world data backs Route 92 reperfusion system
  • LivsMed unveils new surgical robot with telesurgery capabilities
  • JenaValve enrolls first patient in TAVR for AR study
  • HistoSonics expands insurance coverage for histotripsy treatment
  • Johnson & Johnson MedTech gets updated FDA nod for Varipulse PFA

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy