A two-day Food and Drug Administration advisory committee meeting found conflicting reports related to increased late mortality rates in using paclitaxel-coated balloons (DCBs) and paclitaxel-eluting stents (DESs), according to the Regulatory Affairs Professionals Society (RAPS).
“The problem is that the numbers presented by industry and numbers presented by FDA are not the same,” said University of Pennsylvania Medical Center professor of medicine John Hirschfield.
“We have a conundrum in terms of trying to decide what weight to place on each analysis that we see,” he said. “I hope there is a way, it may not be feasible we get this achieved during this meeting, where we get a real common agreement of what the actual numbers are … so we know exactly what data we are dealing with.”
Manufacturers, including those from Medtronic and Boston Scientific, believe the probe into the different numbers is negatively impacting patient care.
Daniel Clair, an adviser for Medtronic, Boston Scientific and DCB, said the FDA’s January letter to health care providers is significant.
“Many clinicians, health care systems have unilaterally made the decision to withdraw these devices from their shelves,” Clair said. “For many physicians, the fear of potential lawsuits has led to these products being essentially unusable in the current environment.”
“Industry has stepped up to the bar and this is a dynamic process,” Bram Zuckerman, director at the office of cardiovascular devices at FDA’s Center for Devices and Radiological Health, said. “However, I would be careful about utilizing the most up to date data analyses. They have not been checked by the FDA and I can say in general terms, because of a multitude of problems, the FDA has had a lot of back and forth with each company to verify data.”