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.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Cook Medical Kicks off Stent Removal Study

Cook Medical Kicks off Stent Removal Study

January 6, 2014

Bloomington, Ind.-based Cook Medical has launched a clinical trial to determine the removability of its Evolution Esophageal Fully Covered Stent. The device is used to maintain patency of malignant esophageal strictures and seal tracheoesophageal fistulas, perforations and leaks.

The prospective, single-arm study — led by a paid consultant for Cook Medical working at the Cleveland Clinic — will evaluate 130 patients at 15 centers across the U.S. Subjects will be followed for up to six months after placement of the self-expanding metal stent, which has been modified with a lasso loop and grasping features on both ends that facilitate removal. Following the stent’s removal, the patients will be followed for another 30 days.

Cook plans to finish enrolling and treating patients by the end of this year, with study results by mid-2015, said spokeswoman Caitlin Davis.

“We are very excited to see where this study takes us, said Barry Slowey, global leader of Cook’s endoscopy division. “We hope that the results of this study will allow for some expanded treatment options for malignant and benign esophageal disease.”

Data generated by the study will be used to seek regulatory approval of the removable stent. “Currently, in the U.S., metal stents are only FDA-cleared for permanent placement in malignant strictures of the esophagus,” Davis said. — Lena Freund

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

Medical Devices Regulatory Affairs Submissions and Approvals Research and Development

Upcoming Events

  • 09Feb

    Maintaining Your Risk-Based Cleaning and Disinfectant Programs: Best Practices During COVID-19

  • 10Feb

    FDA Under the Biden Administration: What’s to Come and What It Will Mean

  • 11Feb

    Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

  • 17Feb

    Effective Auditing for Manufacturing Quality

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Regeneron logo

    Regeneron’s Antibody Cocktail Shows Efficacy as COVID-19 Treatment

  • Mobile apps client cellphone cell phone

    FDA to Review Berkshire’s 510(k) Submission for Remote Drug-Delivery System

  • COVID-19

    Desidustat Improves Oxygenation for Hospitalized COVID-19 Patients

  • abbott-logo.gif

    Abbott’s Panbio COVID-19 Test Gets Additional CE Marks

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 My Personal Information
Footer Logo

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

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing