FDA Panel to Review Cook's Zilver PTX on October 13

September 6, 2011—The US Food and Drug Administration (FDA) announced the forthcoming meeting of a public advisory committee to discuss, make recommendations, and vote on information related to the premarket approval application for the Zilver PTX drug-eluting stent (Cook Medical, Bloomington, IN).

The meeting will be held on October 13, 2011, from 8 AM to 6 PM at the Hilton Washington DC North/Gaithersburg in Gaithersburg, Maryland. The meeting will be open to the public. Further details are available on the FDA's Web site. The FDA intends to make background material available to the public no later than 2 business days before the meeting.

According to the FDA, the proposed indications for use of the Zilver PTX are treatment of de novo or restenotic symptomatic vascular disease of the above-the-knee femoropopliteal arteries that have reference vessel diameters ranging from 4 to 9 mm and total lesion lengths per patient of 280 mm. The Zilver PTX is a self-expanding nitinol stent that is coated on its outer surface with the cytotoxic drug, paclitaxel, without any polymer, binder, or excipient at a dose density of 3 µg/mm². The device is made in diameters of 5 to 10 mm and lengths of 20 to 80 mm and is preloaded onto 6- and 7-F delivery systems. Upon deployment, the Zilver PTX stent expands to establish and maintain patency in the stented region.