Cook Medical said today that it is releasing de-identified patient-level data from a clinical trial of its Zilver PTX peripheral paclitaxel-eluting stent.
The move comes only a month after the 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.
Bloomington, Ind.-based Cook said that it was releasing the data to encourage further collaboration with researchers to improve treatment of peripheral arterial
The Zilver PTX randomized, controlled trial followed 479 patients over five years in the U.S., Germany and Japan.
Cook Medical touted that it is the first company with paclitaxel devices to make its de-identified patient-level data publicly available.
“We will continue to support our customers and their patients by sharing what we’ve discovered from our research and data in the area of paclitaxel,” vascular division VP 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.