FDA updates docs on review of paclitaxel devices for PAD

The FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices. In a letter to healthcare providers, the U.S. regulatory agency reported that there was a 50% increased risk of mortality in people treated with paclitaxel-coated devices versus those treated with control devices in the three trials with five-year follow-up data. Get the full story at our sister site, Drug Delivery Business News. The post FDA updates docs on review of paclitaxel devices for PAD appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Drug-Device Combinations Featured Food & Drug Administration (FDA) Pharmaceuticals Source Type: news