Cooks peripheral stent nets backing from FDA panel
All 11 members of the panel, which convened Oct. 14 in Gaithersburg, Md., 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.
The FDA panel evaluated the two-year results of the multicenter, prospective, randomized Zilver PTX trial, presented at ISET.11, which included 479 patients treated at 55 institutions in the U.S., Japan and Germany; 241 patients were randomized to the Zilver PTX group and 238 to the percutaneous transluminal angioplasty group.
At two years, Dake et al reported that 74.8 percent of arteries remained open in patients who received the drug-coated stents. Also at two years, event-free survival was 86.6 percent for Zilver PTX patients. Events that did occur primarily involved the need to undergo another procedure to open the original blockage, worsening symptoms of PAD and one amputation. No patient deaths were related to the study device or procedure.
"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's peripheral Intervention unit.
Following CE mark approval in 2009, Cook’s Zilver PTX drug-eluting stent is available for sale in 48 countries, including the U.K., Germany, France, Brazil, New Zealand and Taiwan.