Last month, the medtech titan reported that a programming error inadvertently caused mortality data to be omitted from a statistical analysis involving the company’s paclitaxel-coated balloon.
The announcement came on the heels of a meta-analysis published in the Journal of the American Heart Association suggesting that patients treated with paclitaxel devices for peripheral artery disease could be at an increased risk for late death compared to people treated with uncoated balloons.
The revised analysis, according to Medtronic, doubles down on the findings of the initial study. The data still do not suggest a correlation between paclitaxel dose and long-term survival, the company reported.
Medtronic also noted that at five years, there was no statistically significant difference in all-cause mortality between those treated with the drug-coated balloon and those treated with plain balloon angioplasty.
“In line with our commitment to transparency, we have shared all our patient-level data with FDA in support of their paclitaxel safety analysis and will plan to do the same to support the upcoming independent VIVA Physicians analysis,” the company said in a written statement.