Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Drug-Eluting Balloon Angioplasty Treatment Shows Encouraging Results in a Diabetic Population

February 21, 2014 By Journal of Endovascular Therapy

Despite good immediate results, in up to 40 percent of patients, obstructed arteries in the leg treated with a stent will again become blocked. This in-stent restenosis is typically treated with balloon angioplasty to clear the artery. The addition of drug-eluting balloons is showing improved outcomes for restenosis and could become the treatment of choice for femoropopliteal in-stent restenosis.

The current issue of the Journal of Endovascular Therapy offers results of a prospective study seeking to establish the rate of 1-year restenosis in diabetic patients with femoropopliteal in-stent restenosis who underwent treatment with drug-eluting balloon angioplasty. The study is known as Drug-Eluting Balloon in Peripheral Intervention for In-Stent Restenosis, or DEBATE–ISR.

Conventional treatment of restenosis in femoral and popliteal arteries relies on repeat high-pressure dilation with balloons, which has a high rate of recurrent restenosis. The drug-eluting balloon delivers paclitaxel as it expands within the stent. Paclitaxel is an antiproliferative drug that inhibits microtube formation and subsequent ingrowth of smooth muscle cells.

In this study, 44 diabetic patients were treated for femoropopliteal in-stent restenosis with the drug-eluting balloon. After 1 year, their recurrent restenosis rate was compared with that of a control group—42 diabetic patients previously treated with standard balloon angioplasty for in-stent restenosis.

A significant reduction in restenosis was achieved. Study results show that only 19.5 percent of patients treated with the drug-eluting balloon experienced recurrent restenosis after 1 year, whereas those treated with standard balloon angioplasty had a 71.8 percent rate of recurrence. Additionally, only 13.6 percent of patients in the drug-eluting balloon treatment group underwent target lesion revascularization compared with 31 percent of those in the control group.

These results offer reassurance to physicians about the safety of this procedure. They also put forward a promising alternative to the other restenosis technologies and strategies that have shown mixed outcomes.

An accompanying commentary notes that while further studies are needed, these results are encouraging. The authors point out the limitations of the study, including the absence of randomization and use of the historical control group. However, they state that the results for these diabetic patients “are particularly impressive in light of the high-risk patient population being treated.”

Full text of the article, “Paclitaxel-Eluting Balloon vs. Standard Angioplasty to Reduce Recurrent Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: The DEBATE-ISR Study” and commentary article, Journal of Endovascular Therapy, Vol. 21, No. 1, 2014, are now available at jevt.org.

Related Articles Read More >

Verily Study Watch
Verily says its Study Watch could identify heart failure risk
A child using a medical device at home.
Device design takes the spotlight among 2024’s top health tech hazards
These 11 medical device inventions are the best of 2023, Time magazine says
A photo of a Best Buy Geek Squad employee helping a chronic care patient with a remote monitoring device.
Device manufacturers have an unexpected ally for at-home health care
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

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

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
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • 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 our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. 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 LLC. 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
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe