Executives from Medtronic and Boston Scientific stood behind their companies’ paclitaxel-coated medical devices after a meta-analysis published in the Journal of the American Heart Association in December linked balloons and stents covered with the material to a significantly increased risk of death at two and five years of follow-up.
In that JAHA report, the authors said the findings were “of particular concern because most of the interrogated devices have already received clearance by regulatory authorities and are currently under routine clinical use.” They said additional investigations into those devices were “urgently warranted.”
Shortly after those results were published, two studies evaluating drug-eluting devices in patients with peripheral artery disease were halted.
But representatives from Medtronic and Boston Scientific told investors at the J.P. Morgan Healthcare Conference in San Francisco last week that their internal data doesn’t match the findings from the JAHA meta-analysis, the Star Tribune reported. Medtronic’s In.Pact Admiral drug-coated balloon contains the anti-inflammatory drug paclitaxel, as do Boston Scientific’s Ranger drug-coated balloon and Eluvia drug-eluting stent.
“We’ve generated a ton of clinical evidence: 1,800 patients, we have data out to five years, randomized controlled study for the U.S., randomized controlled clinical study for Japan, global registry data,” Mike Coyle, president of Medtronic’s Cardiac and Vascular Group, told investors Jan. 7, according to the Star Tribune. “And all of these data have been analyzed. We have not seen this safety signal in our data.”
Boston Scientific’s global chief medical officer, Ian Meredith, said the data offered no explanation for what might have caused the increased death rates observed with paclitaxel-coated balloons and stents.
“I think at this stage, good clinical studies are appropriate,” Meredith said. “There does not seem to be a plausible mechanism to understand how a dose that is imperceptible in plasma or tissue at 30 days could actually really affect mortality two years and beyond.”
Read the Star Tribune’s full story below:
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.