October 14, 2011 – A U.S. Food and Drug Administration (FDA) review panel gave its unanimous recommendation for the market approval of the Zilver PTX stent. It is the first device of its kind on several fronts to go before FDA review. It is the first drug-eluting stent (DES) for peripheral leg vessels, the first self-expanding DES and the first DES that does not use a polymer to load and elute its drug.
All 11 members of the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee voted Oct. 13 in favor of Cook Medical's 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 United States.
“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.”
The FDA is not bound by decisions made by its panels, but usually follows their recommendations. Final FDA review will likely take place by the end of the year, or the beginning of 2012.
Following CE mark approval in 2009, Cook Medical’s Zilver PTX DES is now available for sale in 48 countries around the world including the United Kingdom, Germany, France, Brazil, New Zealand and Taiwan.
The stent is seen by many experts as a major step forward in treatment options for patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA). Occlusions in the SFA are difficult to treat and frequently re-occlude.
Zilver PTX is made of nitinol, a shape memory metal alloy that will spring back into its original shape under axial, torsional and bending flexibility. Self-expanding stents are used in the SFA because of the need to torque and compress with the vessel.
The addition of the anti-tissue proliferation drug paclitaxel on the Zilver stent has shown promising results in clinical trials in lowering the usually high restenosis rates of SFA lesions.
Polymers used to load drugs and control drug elution on DES have been implicated as the culprit in late-stent thrombosis sometimes seen in coronary stents. Vendors have been researching ways to eliminate polymers, allowing DES to become a bare metal stent following full drug elution into the vessel wall. The Zilver PTX would be the first DES in the United States not to use polymer, which is seen by many interventional experts as the way of the future.
For more information: www.cookmedical.com