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Cook Medical’s New BTK DES to Treat CLTI Receives FDA Breakthrough Designation

January 21, 2022—Cook Medical announced it has received Breakthrough Device designation from the FDA on a new drug-eluting stent (DES) for below-the-knee (BTK) application.

FDA Approves Cook Medical's Zenith Dissection Endovascular System

February 4, 2019—Cook Medical announced FDA approval of its Zenith dissection endovascular system.

Cook Medical’s Zilver Vena Venous Stent Receives FDA Approval

October 15, 2020—Cook Medical has announced United States FDA premarket approval of its Zilver Vena venous stent.

Cook Medical’s Zenith Thoraco+ Endovascular System Gains FDA Breakthrough Device Designation

April 1, 2022—Cook Medical announced that its Thoraco+ endovascular system has received Breakthrough Device designation from the FDA.

Cook Medical Provides Patient-Level Paclitaxel Data From Zilver PTX Randomized Controlled Trial

April 18, 2019—Cook Medical announced that patient-level data from the Zilver PTX randomized controlled trial (RCT) of the company's paclitaxel-eluting peripheral stent is available by request on the company's website.

Japanese Postmarket Surveillance Data for Zilver PTX Presented at EuroPCR 2014

May 29, 2014—At last week’s EuroPCR 2014 meeting, Hiroyoshi Yokoi, MD, of Fukuoka Sanno Hospital presented 1-year data from from a postmarket surveillance study of 907 Japanese patients who were treated using the Zilver PTX peripheral drug-eluting stent (Cook Medical) in the superficial femoral artery.

Prediction Model Developed for Patient Outcomes With Cook Medical’s Zilver PTX DES

September 14, 2020—Cook Medical announced that a prediction model for treatment outcomes with the company’s Zilver PTX paclitaxel-coated drug-eluting stent (DES) was presented by Michael Dake, MD, at the Cardiovascular and Interventional Radiological Society of Europe’s CIRSE 2020 Summit held online September 12-15.

Cook Medical Resolves 2014 FDA Warning Letter

September 11, 2018—Cook Medical announced it has received a close-out notification from the US Food and Drug Administration, resolving the warning letter issued to the company in September 2014.

Cook Begins Relaunch of Beacon Tip Catheter Line

April 2, 2018—Cook Medical has begun reintroducing its line of Beacon Tip angiographic catheters, starting in the United States and Canada with the 5-F Beacon Tip Torcon NB Advantage line.  Certain lots of the workhorse radiopaque-tipped catheter line were voluntarily recalled starting in 2015, and in 2016, Cook announced that the entire product line was being pulled due to tip splitting and/or fracture.