ZILVERPASS trial is a randomised, multicentre clinical study that enrolled 220 patients across four countries to evaluate Zilver PTX
Image: Cook Medical's paclitaxel-coated stent Zilver PTX. Photo: Courtesy of Business Wire.
A randomised controlled trial showed that Cook Medical’s paclitaxel-coated stent Zilver PTX has lesser complications and shorter hospital stays for patients with peripheral artery disease (PAD), compared to traditional bypass surgery.
Cook Medical said that it has funded a five-year physician-sponsored clinical trial ZILVERPASS to compare the treatment using Zilver PTX with the traditional open prosthetic bypass surgery.
Cook Medical vascular division vice president Mark Breedlove said: “Our mission with Zilver PTX — and with every product we make at Cook Medical — is to try to improve people’s lives. Cook Medical has released extensive data around Zilver PTX, and this device continues to show benefits across a wide spectrum of patients.
“We hope that by continuing the conversation around paclitaxel, physicians and patients can make more informed decisions.”
Cook Medical has initiated ZILVERPASS to unveil the impact of Zilver PTX
ZILVERPASS trial was a randomised, multicentre clinical study that enrolled 220 patients across four countries, to evaluate the effectiveness of Zilver PTX in treating patients with PAD.
Cook Medical said that that the patients treated with its paclitaxel-coated stent had an average of five days shorter hospital stay, compared to the traditional bypass surgery.
In addition, patients treated with Zilver PTX for long and complex lesions were 60% less likely to have complications thirty days after the procedure, compared to the patients who had bypass surgery.
According to the two-year data, other clinical outcomes of its stent were comparable to those of bypass surgery, and the ongoing study will continue to collect results through five years, said the company.
Cook Medical was established in 1963 in Bloomington, Indiana, US, as a medical device company, and has worked with physicians to develop minimally-invasive devices, and technologies that eliminate the need for open surgery for patients.
The company claims that it combines medical devices, biologic materials and cellular therapies to enable the healthcare systems to deliver better outcomes.