Dive Brief:
- The U.S. Food and Drug Administration has found paclitaxel-coated devices are unlikely to increase the risk of death when used to treat peripheral arterial disease (PAD), the agency announced Tuesday.
- Concerns about the safety of stents and balloons coated with the drug paclitaxel emerged late in 2018, when a meta-analysis linked the devices to increased risk of death. The FDA responded by alerting healthcare professionals to the data and adding the mortality signal to product labels.
- Since then, the agency has worked with manufacturers of the devices on a new meta-analysis. The updated analysis “does not support an excess mortality risk for paclitaxel-coated devices,” leading the FDA to outline plans to update product labels.
Dive Insight:
Manufacturers including Boston Scientific, Cook Medical, C.R. Bard and Medtronic were affected by the safety warnings on paclitaxel-coated devices. Although updates from the companies have helped alleviate concerns, regulatory changes imposed in response to the meta-analysis have remained in place.
The situation in the U.S. is now set to change. Responding to an updated meta-analysis, the FDA said it will work with device manufacturers to “update product labeling based on the current available data.” The agency is advising physicians to discuss the risks with patients and continue routine monitoring.
The updated meta-analysis included “additional studies, more complete vital status information, and longer-term follow-up.” Patient follow-up in the included studies ranged from two to five years. A review of the data by FDA clinicians and statisticians found no evidence of a late mortality risk.
The FDA’s conclusion and decision to remove warnings from device labels is a boost to manufacturers of paclitaxel-coated devices. Michael Jaff, chief medical officer and vice president, peripheral interventions, Boston Scientific, welcomed the news.
“We are pleased that, after continued analysis of data and collaboration among a broad set of stakeholders, the FDA has determined the large body of long-term clinical data do not support an excess mortality risk for paclitaxel-coated devices used to treat patients with PAD,” Michael Jaff, Boston Scientific’s chief medical officer and vice president of peripheral interventions, said in a statement.
