Cook Medical Gains FDA Approval for 5-mm Zilver PTX Drug-Eluting Stent Diameter
September 24, 2018—Cook Medical announced the FDA approval of a 5-mm diameter version of the Zilver PTX paclitaxel-eluting peripheral stent. Zilver PTX is now available with an indication to treat vessel diameters ranging from 4–7 mm.
The 5-mm device is available in lengths up to 140-mm; in August 2018, Cook introduced its 6- and 7-mm diameters in 140-mm lengths. The company noted that the 5-mm diameter is the first peripheral DES approved in this size.
Also this week, during the annual Cardiovascular and Interventional Radiological Society of Europe (CIRSE) meeting in Lisbon, Portugal, Prof. Kimihiko Kichikawa, MD, presented 5-year data from the company's Japan Postmarket Surveillance Study. In this all-comers evaluation of Zilver PTX in Japan, the results included a freedom from target lesion revascularization rate of 74.2%. More information on the Japan Postmarket study can be found here.