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.
You may also be interested in...
R&D Roundup, November 2019: LimFlow Starts Pivotal Trial Of Peripheral Shunt; Conservative Coronary Treatment Matches Intervention In Trial
An overview of November’s 10 most-read Medtech Insight articles on topics related to research and development of new medical technology.
A review of German insurance data found no additional risk of death in patients treated with drug-coated balloons and stents, even in patients who had the devices for more than a decade. The data appears to further challenge a bombshell meta-analysis that claimed paclitaxel could increase death rates by up to 90%.
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.