We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs, Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Daily Bulletin
    • Drug Industry Daily
  • Device News
    • Trending
    • Commercial Operations
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Daily Bulletin
    • FDAnews Device Daily Bulletin Premium
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Grants IDE for Ebola Plasma Transfusion System

FDA Grants IDE for Ebola Plasma Transfusion System

November 24, 2014

Cerus said Friday that the FDA has given it the go-ahead to begin clinical studies of the INTERCEPT Blood System, which will be used to treat plasma from Ebola survivors before it is transfused into patients currently fighting the disease.

The plasma of people who have recovered from the virus contains antibodies that can help fight Ebola infection in others, but it can also contain common pathogens like bacteria, viruses and parasites, making treatment of the plasma imperative, Cerus says. INTERCEPT is designed to inactivate these pathogens in the convalescent blood plasma before it is transmitted to the patient.

The trial will be conducted at Emory University Hospital in Atlanta and the University of Nebraska Medical Center, two sites that have previously treated Ebola patients and possess the infrastructure and experience for carrying out the procedure, the Concord, Calif., devicemaker said.

Under the investigational device exemption approved by the FDA, Emory will collect plasma from recovered Ebola patients and run it through the INTERCEPT system. The Centers for Disease Control and Prevention will then test the treated plasma for Ebola antibodies and return it to Emory to be stored for future use. Emory will supply treated plasma to the University of Nebraska as needed.

Cerus and the hospitals are also working with the Red Cross and America’s Blood Centers to create a national network of plasma collection sites to recover plasma from Ebola survivors, the company said.

Cerus hopes to win FDA approval for the INTERCEPT system in 2015. It is currently CE-marked. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.

Devices Submissions and Approvals

Upcoming Events

  • 04Apr

    Optimizing Quality Control Operations with Unified Quality

  • 20Apr

    Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • GrayMatters Health’s Digital Therapy Device for PTSD Cleared

  • Dupixent Shows Positive Results in COPD Study

  • Advamedica’s Hemostat Cleared for Severe Surgical Bleeding

  • FDA Approves Sandoz’s Citrate-Free Adalimubab Formulation

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing