FDA Announces More Actions On Drug-Coated Devices
Executive Summary
The US FDA’s latest update on the safety of paclitaxel-coated balloons and stents urges additional clinical trials. The agency also plans updates to device labeling and clinical trial informed consent documents that will reflect evidence that the devices may pose a mortality risk.
You may also be interested in...
FDA-Guided Study Finds No Paclitaxel Death Risk In Medicare Patients
The SAFE-PAD study, which looked at data from more than 168,000 Medicare beneficiaries, found a slightly lower death rate in patients treated with drug-coated balloons and stents than those who were not.
VIVA 2019: New Paclitaxel Data Shows Consistent Mortality Signal, No Clear Cause
Research investigating outcomes in patients treated with paclitaxel-coated devices demonstrated a consistent if modest mortality signal when compared to bare-metal stents. However, the signal was not seen in real-world data, and some researchers question whether the signal might stem from problems in the original trials.
TCT 2019: BD, VIVA Data Show Lower Paclitaxel Mortality Risk
BD said an independent Lutonix review found no significant link to deaths, while further meta-analysis from trade group VIVA showed a decline in the risk. Both studies were unveiled at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.