• 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 launches study of In.Pact Admiral drug-coated balloon in end-stage renal disease

May 24, 2017 By Sarah Faulkner

Medtronic's In.Pact Admiral DCBMedtronic (NYSE:MDT) said today that the 1st patient was enrolled in a study of its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease.

The FDA approved the investigational device exemption study to evaluate the device as a treatment for failing arteriovenous fistulas in end-stage renal disease patients.

“We are delighted to enroll and treat the 1st patient in this significant study of In.Pact AV Access DCB in patients with obstructed AV access,” principal investigator Dr. Jeffrey Hull said in prepared remarks. “Maintaining access patency is critical to delivering dialysis treatment, and for salvaging failing AV fistulas. Durable treatment options in these patients are limited.”

The IDE study is slated to enroll 330 patients and randomize them to receive either treatment with the In.Pact balloon or standard percutaneous transluminal angioplasty. The study’s primary efficacy endpoint is patency of dialysis fistulas through 6 months and the primary safety endpoint is serious adverse events through 30 days.

Millions of patients with end-stage renal disease undergo dialysis using an AV access site, but over time, thickening of the vessel walls limits the site’s accessibility. This can necessitate repeat intervention to open up the patient’s vessels.

“This important clinical study is designed to address the clinical need for new, innovative options for patients with limited AV access,” national principal investigator Dr. Robert Lookstein said. “DCBs are supported by clinical evidence in patients with peripheral artery disease in the upper leg. We hope that this study may provide data to support this DCB’s use to improve patency and reduce the need for repeat interventions in AV access sites for patients on dialysis.”

“Through our ongoing dialogue with the clinical community, we recognize that maintaining patency at AV access sites for dialysis patients is a critical challenge,” Mark Pacyna, GM of Medtronic’s peripheral business, added. “Advancement of this study demonstrates our strong commitment to addressing challenging lesions and improving patient care in patients with ESRD.”

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Vascular Tagged With: Medtronic

IN CASE YOU MISSED IT

  • Shareholder lawsuit over BD’s Alaris pumps recall moves forward
  • Embecta stock soars on first full-quarter results after BD spinoff
  • Abbott will spend $450M to up FreeStyle Libre production in Ireland
  • Better Therapeutics Q2 beats Street as it prepares to submit diabetes therapy for FDA review
  • Study backs Fluidx embolic device for vessel filling

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
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
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