The Zilver® PTX® 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.
Source: Cook Medical