UK to probe safety of paclitaxel cardiovascular devices
Regulators in the United Kingdom have formed an expert advisory group to assess the safety of stents and balloon catheters featuring paclitaxel, casting further doubt on the category of devices and their manufacturers.
U.K. authorities initiated the investigation in response to a recent meta-analysis that linked the use of paclitaxel in certain cardiovascular devices to a significant increase in deaths, as compared to non-coated balloons or bare metal stents.
The statement does not mention devices by name but studies of products sold by Boston Scientific, Cook Medical, C.R. Bard, Medtronic and other companies were included in the meta-analysis. The findings triggered a flurry of actions, including an FDA alert to physicians and publications from Medtronic and others citing data that suggest the use of paclitaxel is safe.
The series of publications have given regulators a lot of data to review but, as it stands, failed to offer a clear picture of the safety of paclitaxel drug-coated balloon catheters and drug-eluting stents.
Authorities in the U.K. have spent the months since the publication of the meta-analysis gathering and analyzing the available information, culminating in the formation of the expert advisory group. The physicians and scientists have been tasked with assessing whether the results of the meta-analysis and single-device clinical trials are statistically robust.
Medtronic has been among the more vocal defenders of its paclitaxel products. The company shared five-year data showing no link between its Admiral paclitaxel-coated balloon and death rates within a week of the FDA alert, although the authors of the paper on its device have since issued a correction related to mortality data. Medtronic maintains there is no correlation to death after the correction.
It is unclear what impact these probes will have on manufacturers, but data corrections "aren't helping the paclitaxel narrative," Needham & Company analysts wrote in a recent note. But the analysts also reported that at a paclitaxel devices safety discussion at last week's Cardiovascular Research Technologies conference in Washington surveyed panelists indicated they believed labeling for these devices ought to remain unchanged.
The U.K. expert group will also assess whether there is evidence for a causal link between paclitaxel and increased mortality. Other researchers are yet to identify a causal link but the U.K. is unsure whether this is because of "limitations in the way the data were analyzed."
As it stands, the devices remain on the market and are not subject to new regulatory restrictions. The findings of the experts could change the situation, though. The experts will report their findings to the U.K. device regulator within a few months. After that, the agency will assess whether regulatory actions are required.
- MHRA Expert Advisory Group set-up to review paclitaxel drug-coated balloon catheters and drug-eluting stents
- MedTech Dive FDA flags mortality risk of paclitaxel with stents, balloons for PAD
- MedTech Dive Medtronic data show no paclitaxel-mortality link amid FDA warnings
- MedTech Dive Medtronic says corrected IN.PACT analysis to be published in JACC