FDA Advisers Back Cook Medical Stent for Leg Arteries
10/13/2011 6:39:29 PM
Cook Medical's Zilver(R) PTX(R) Drug-Eluting Stent Technology Receives Unanimous Recommendation from FDA Advisory Committee
U.S. health advisers on Thursday unanimously backed a new Cook Medical stent coated with a common cancer-fighting drug to treat clogged arteries in the thighs. A panel of outside experts to the Food and Drug Administration said the Zilver PTX stent was safe and effective for keeping blood vessels above the knee free from plaque.
GAITHERSBURG, Md., Oct 13, 2011 (BUSINESS WIRE) -- The Zilver(R) PTX(R) Drug-Eluting Stent, the first device of its kind developed to treat peripheral artery disease (PAD) in the superficial femoral artery (SFA), has received a unanimous recommendation from the Food and Drug Administration's (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee, Cook Medical announced today. The panel convened today in the Washington, DC area and all 11 of its members voted to recommend approval of the device on the basis of its safety, efficacy and acceptable risk profile. The recommendation is the latest step in the regulatory review process that the company hopes will ultimately lead to FDA approval to sell the Zilver PTX stent in the U.S.
"Cook Medical is very pleased that the FDA's Circulatory System Devices Panel has recognized the merits of Zilver PTX, and we look forward to a final decision on approval to market this device in the U.S. from the FDA in the coming months," said Rob Lyles, vice president and global leader of Cook Medical's peripheral intervention unit. "Cook Medical is dedicated to continually innovating and delivering medical devices that improve the quality of patient care worldwide, and we wholeheartedly feel Zilver PTX provides a great example of that patient-focused business philosophy."
Following CE Mark approval in 2009, Cook Medical's Zilver PTX Drug Eluting Stent is now available for sale in 48 countries around the world including the United Kingdom, Germany, France, Brazil, New Zealand and Taiwan, Lyles added.
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit CookMedical.com. Follow Cook Medical on Twitter @CookMedicalPR.
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SOURCE: Cook Medical
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