The company noted that the mistake ultimately does not affect the conclusion that there was no statistically significant difference in all-cause mortality between its In.Pact Admiral drug-coated balloon and plain balloon angioplasty at five years.
The medtech titan announced that two studies centered around its In.Pact Admiral balloon are undergoing revisions. The company said it immediately notified the FDA and study authors after it was made aware of a “programming error” that caused mortality data to be omitted for the summary tables included in the statistical analysis.
The revelation comes as some in the interventional cardiology industry are questioning the long-term safety of paclitaxel devices.
A meta-analysis published in the Journal of the American Heart Association in December suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared to people treated with uncoated balloons.
Led by Dr. Konstantinos Katsanos, researchers analyzed data from 28 trials and found that there was a 68% relative risk increase in all-cause death with paclitaxel-coated devices after two years and a 93% relative risk increase after five years compared to therapy with an uncoated balloon.
In a letter to healthcare providers, the FDA said that the benefits of paclitaxel-coated devices still outweigh the risks “when used in accordance with their indications for use.”
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.