FDA Panel Recommends Approval of Cook's Zilver PTX Stent to Treat SFA Disease

October 13, 2011—Cook Medical (Bloomington, IN) announced that the company’s Zilver PTX drug-eluting stent for treating peripheral artery disease in the superficial femoral artery (SFA) has received a positive recommendation from the US Food and Drug Administration’s (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee. The public meeting of the panel was convened in Gaithersburg, Maryland.

The panel members voted unanimously to recommend approval of the device on the basis of its safety, efficacy, and acceptable risk profile. The company stated that it hopes that achieving this step in the regulatory review process will ultimately lead to FDA approval to market the Zilver PTX stent in the United States.

The FDA summarized the device and its proposed indications for use in the agency’s notice of the meeting posted on September 6.

The FDA advised that 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.

According to the FDA, the proposed indications for use of the Zilver PTX stent 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.

Cook Medical stated that the device received CE Mark approval in 2009 and is currently available for sale in 48 countries around the world including the United Kingdom, Germany, France, Brazil, and Taiwan.

Background materials for the meeting, including Cook Medical’s Executive Summary presented for the panel’s review, were made available on the FDA Web site. The Executive Summary details the device’s features, its preclinical development and testing history, and the clinical trial data.

Zilver PTX Study Results Published

Also on October 13, Cook Medical announced the publication of scientific data on the Zilver PTX drug-eluting stent. 

Michael D. Dake, MD, et al published 12-month results from the randomized Zilver PTX study online ahead of print in Circulation: Cardiovascular Interventions. The investigators concluded that femoropopliteal peripheral artery disease treatment with the paclitaxel-eluting stent was associated with superior 12-month outcomes compared with percutaneous transluminal angioplasty and provisional bare-metal stent placement.

In the Journal of Endovascular Therapy, Dr. Dake et al published 12-month safety and effectiveness results from the Zilver PTX global registry (2011;18:613–623). The investigators stated that the results of this single-arm clinical study indicate that the Zilver PTX stent is safe for the treatment of patients with de novo and restenotic lesions in the above-the-knee femoropopliteal segment and concluded that the 1-year overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy.

Endovascular Today will continue to provide coverage of the FDA advisory panel meeting and developments in the regulatory review process for the Zilver PTX stent.

Previously in Endovascular Today: Cook Medical's 2-Year Zilver PTX Trial Results Presented at ISET

Cook’s Zilver PTX Compares Favorably to PTA for SFA Treatment in Diabetic Patients