Cook Medical has released de-identifiable patient-level data from a clinical trial of its Zilver PTX peripheral paclitaxel-eluting stent.
The move comes a month after the US Food and Drug Administration (FDA) said that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices.
Cook Medical said that it was releasing the data to encourage further collaboration with researchers to improve treatment of peripheral arterial. The company website states: “In the spirit of full transparency, Cook Medical is providing our extensive long-term data on Zilver PTX, our drug eluting stent. Zilver PTX is a paclitaxel-coated stent that was approved by the FDA in 2012 through the premarket approval process.”
The Zilver PTX randomised, controlled trial followed 479 patients over five years in the USA, Germany and Japan.
Cook Medical touted that it is the first company with paclitaxel devices to make its de-identifiable patient-level data publicly available.
“We will continue to support our customers and their patients by sharing what we have discovered from our research and data in the area of paclitaxel,” vascular division vice president Mark Breedlove said in a press release.
Last September, Cook Medical said that it won FDA approval for a smaller-diameter version of its Zilver PTX peripheral drug-eluting stent.