Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

GI Dynamics touts results of U.K. study

March 18, 2019 By Nancy Crotti

GI Dynamics (ASX:GID) said a retrospective study of its EndoBarrier device for patients with type 2 diabetes and obesity shows a significant reduction in HbA1c, weight, liver fat and cardiovascular disease (CVD) risks as well as a reduction in the need for insulin in some patients.

The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract, according to the Lexington, Mass.-based company.

The study by the U.K.’s National Health Service (NHS) is based on data collected from the first implant in October 2014 to the last explant in November 2018. Results were released at the recent Diabetes UK Professional Conference 2019 in Liverpool.

The primary outcome of HbA1c, weight, CVD risk factors and alanine aminotransferase (ALT — a liver fat measure) show a significant reduction at explant compared to baseline values. Of the 61 patients studied, 35 were on insulin prior to treatment. At explant, 10 of the 35 (28.6%) discontinued their use of insulin. The most significant outcome measure is the 2.2 absolute percent reduction of HbA1c at 12 months with a concurrent weight loss of 35 lbs.

Further analysis of the data using the U.K. Prospective Diabetes Study risk engine led principal investigator Dr. Robert Ryder of Sandwell and West Birmingham hospitals to hypothesize that approximately 8 of 100 patients who have EndoBarrier implanted would avoid coronary heart disease or a stroke over the next 10 years.

“We are pleased to share the final outcome from this study, which suggests EndoBarrier can provide significant improvements for patients with long-standing poorly controlled diabetes and obesity, who have been unable to manage their diabetes with standard treatment options,” Ryder said in a prepared statement. “Further evidence and research suggest EndoBarrier contributes to the reduction of other comorbidities associated with type 2 diabetes and obesity.”

“This expanded data set from the NHS EndoBarrier service continues to develop the breadth of support for clinical efficacy of EndoBarrier in a real-world clinical setting,” added GI Dynamics’ president & CEO Scott Schorer. “The significant reduction of HbA1c, weight and improvement in numerous markers — including reduction in cardiovascular risk and elimination of insulin use for 28 percent of patients — is substantial.”

GI Dynamics won Institutional Review Board approval to launch a pivotal trial of EndoBarrier in the U.S. last month. The approval, which follows FDA approval it won last August, is a boon for the company, which has faced a number of hurdles with its device over the past few years, including shutting down an initial FDA-approved study, being pulled off the shelves in Australia and losing its CE Mark approval in the European Union.

Related Articles Read More >

A portrait of Zimmer Biomet CEO Bryan Hanson
Zimmer Biomet narrowly avoids shareholder rebuke on executive pay
A portrait of Britt Meelby Jensen, the new CEO of Ambu
Ambu replaces CEO with new leadership
AdvaMed
AdvaMed joins Biden’s Joint Supply Chain Resilience Working Group
A photo of former FDA official Bakul Patel
Google Health hires FDA’s chief digital health officer

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 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.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech