- On Wednesday, FDA's Circulatory System Devices Panel Advisory Committee agreed with an agency staff assessment that a mortality signal is associated with paclitaxel-coated balloons and paclitaxel-eluting stents.
- The panel struggled with the quality of postmarketing data collected by industry, concluding there isn't enough data to determine a class effect or cause of death.
- BD, Medtronic, Boston Scientific, Philips and Cook Medical largely argued in presentations there isn't any mortality signal present for devices after taking additional data into account, and said the safety profile of their devices outweighs the risks.
Daniel Clair, an advisor to Medtronic and Boston Scientific and a consultant for BD, argued to the panel that the FDA's safety communication has already effectively removed paclitaxel devices from the market.
"For many clinicians, healthcare systems have unilaterally made the decision to withdraw these devices from their shelves," said Clair, who is also the chair of the department of surgery at the University of South Carolina's Palmetto Health-USC Medical Group. "And, for many physicians, the fear of potential lawsuits has led to these products being essentially unusable in the current environment."
In its executive summary for the advisory committee, FDA published the results of a patient-level meta-analysis it argues demonstrated a late mortality safety signal associated with the paclitaxel devices used to treat femoropopliteal disease. The agency couldn't determine a cause for the increased risk of death and called for additional data to better understand which patient groups are at risk.
One panel member, John Hirshfeld Jr., a professor at the University of Pennsylvania Perelman School of Medicine, expressed concern that industry and FDA presented conflicting numbers.
"The problem is that the numbers presented by industry and the numbers presented by FDA are not the same. We have a conundrum in trying to decide what weight to place on each analysis that we see," Hirshfeld said.
The panel's struggles to answer FDA's questions with the data presented reflect the challenges for how physicians choose to use the devices, RBC Capital Markets' Brandon Henry wrote in an analyst note.
"Companies have been working on collecting as much of the missing data as possible and presented updated analysis at the meeting," Henry said. "However, the FDA has not independently reviewed the updated datasets and, therefore, cannot vouch for the validity of the revised analysis."
Circulatory System Devices Panel Chair Richard Lange said companies often take postmarketing study requirements for devices "with variable amounts of seriousness."
"People are disappointed that there is missing data. What we as a panel are saying is that it makes it very difficult for us to interpret the data. What we are left with is incomplete data, very good analysis, a signal, a smoking gun, but no bullet or dead body. The missing data could make the data look better; it could make it look worse," Lange said.
The panel meets again Thursday to discuss recommendations on the risks and benefits of the devices, post-market studies and labeling.