FDA approves Integra Dermal Regeneration Template — 5 highlights

Spinal Tech

The FDA has approved the PMA Supplement for Integra LifeSciences' Dermal Regeneration Template.

Here are five highlights:

 

1. IDRT will be used for the treatment of diabetic foot ulcers.

 

2. The approval of this new indication is based on results from the FOUNDER Study, a multicenter, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption.

 

3. The study found that patients treated with IDRT demonstrated a 59 percent improvement in the incidence of complete wound closure compared to standard care.

 

4. According to Lawrence A. Lavery, DPM, FOUNDER Study principle investigator, this product has been used in the operating room to treat life-threatening third degree burns since 1996, and can now be used in the clinic to treat patients who suffer from diabetic foot ulcers.

 

5. Prevalence of diabetes continues to rise, currently affecting an estimated 30 million people in the United States. As many as 15 percent of those diagnosed may experience a diabetic foot ulcer in their lifetime.

 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Webinars

Featured Podcast

Featured Whitepapers