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

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Medtronic wins FDA approval for new extended-wear infusion set

August 16, 2019 By Sean Whooley

Medtronic

Medtronic (NYSE:MDT) said it earned investigational approval from the FDA to proceed with a trial for a new extended-wear infusion set.

The goal of the study is to collect clinical data that supports the use of the device for up to seven days, more than twice the amount of time any infusion set can currently be used, according to a news release.

The 150-patient, non-randomized trial is slated to involve subjects between 18 and 80 years old with Type 1 diabetes on insulin pump therapy. The infusion sets allow people on insulin pump therapy to deliver insulin under the skin. Current sets are changed every two to three days, according to the release.

Users of Fridley, Minn.-based Medtronic’s MiniMed 670G system will wear each infusion set for up to seven days in the trial.

The changing of the infusion set and glucose monitor would be coordinated after seven days with Medtronic’s new device. Dani Labriola, whose son uses the MiniMed 670G system to manage his diabetes, highlighted the convenience of Medtronic’s proposed device in prepared remarks.

“I would love for my son to spend less time thinking about his diabetes and more time living his best life,” Labriola said. “Changing his set once per week instead of two to three times would take away some of that burden and would make a difficult disease easier.”

“There have been significant advances made in the three-plus decades with insulin pumps and continuous glucose monitoring,” added Dr. Satish Garg of the University of Colorado’s Barbara Davis Center. “However, we are still stuck with having patients change the insulin delivery sets every two to three days whereas most CGMs are now used longer. It is time for an infusion set to extend wear to a week and beyond. This is long overdue and will likely improve quality of life for patients on insulin pumps, and many more patients may accept insulin pump as an option.”

Filed Under: Clinical Trials, Diabetes, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Medtronic

IN CASE YOU MISSED IT

  • BD, Mitsubishi Gas Chemical partner on better materials for plastic syringes
  • ApiJect picks up $111M investment from Royalty Pharma, Jefferies
  • FDA approves IND for Ananda Scientific’s PTSD treatment with liquid structure delivery tech
  • Medtronic’s Resolute Onyx drug-eluting stent demonstrates strong safety, efficacy
  • Jabil launches Qfinity reusable auto-injector

Primary Sidebar

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.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech 100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Souring
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · 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.

Advertise | Privacy Policy | RSS