On 13 October, Cook Medical announced that Zilver PTX, the drug-eluting stent developed to treat peripheral artery disease in the superficial femoral artery, has received a unanimous recommendation from the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee.
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 USA.
“Cook Medical is very pleased that the FDA’s Circulatory System Devices Panel has recognised the merits of Zilver PTX, and we look forward to a final decision on approval to market this device in the USA from the FDA in the coming months,” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention unit.
Following CE mark approval in 2009, Cook Medical’s Zilver PTX is now available for sale in 48 countries around the world including the United Kingdom, Germany, France, Brazil, New Zealand and Taiwan, Lyles added.