FDA warns of safety risks with Abbott's dissolving stent: 5 takeaways

The Food and Drug Administration is warning clinicians that patients implanted with Abbott Laboratories' Absorb dissolving stent may experience more heart issues than those implanted with the company's Xience drug-eluting stent.

Here are five things to know.

1. Abbott's dissolvable stent is used to open blood vessels in the heart blocked by plaque. The stent, which gradually dissolves into the body over time, earned FDA approval in July 2016.

2. Two-year data from a clinical study shows patients treated with the Absorb stent had an 11 percent rate of major adverse cardiac events, compared to 7.9 percent of patients implanted with the Xience drug-eluting stent.

3. Patients also had a 1.9 percent rate of developing blood clots with the Absorb stent, compared to a 0.8 percent risk with the Xience stent after two years.

4. The agency notes patients were more likely to have an adverse cardiac event if the device was placed in a small heart vessel.

5. The FDA is encouraging clinicians to follow instructions on the device's label for how to properly choose a heart vessel for implantation to reduce the risk of serious cardiac events.

More articles on supply chain:

Do drugmakers profit from price hikes? Eli Lilly's new report says 'no'
Less than 40% of patient advocacy groups have favorable view of pharma industry
Trump calls for drug cost measure in AHCA

Copyright © 2023 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars