Cook Medical is proudly announcing FDA approval of its Zilver PTX paclitaxel eluting stent for treating occlusions in the superficial femoral artery (SFA). This is the first drug eluting stent approved in the U.S. for peripheral artery disease (PAD).
The news follows a unanimous recommendation given a year ago for the approval from an FDA advisory committee.
From the announcement:
In order to supply as many physicians as possible with this new technology, Cook is making Zilver PTX available initially in 80 mm lengths in 6 mm and 7 mm diameters. The products indications for use also allow two Zilver PTX 80 mm stents to be overlapped to treat longer lesions up to 140 mm. The FDA approval also includes 40 mm and 60 mm lengths, which will be introduced to the U.S. early in 2013. Cook expects to receive regulatory approval for 120 mm length stents in both diameters next year.
Data from Cook’s pivotal clinical trial indicate:
- Eight out of ten patients treated with Zilver PTX still had open arteries (primary patency) after one year1. That compares to only 3 out of 10 patients treated with angioplasty alone.
- Patients who received a bare metal stent required more than twice as many reintervention procedures to reopen the SFA as patients who received Zilver PTX.2
Flashbacks: Cook Medical’s Zilver PTX Drug-Eluting Stent Receives Unanimous Recommendation from FDA Advisory Committee; Zilver PTX Drug Eluting Stent for Peripheral Artery Disease Gets European Approval; Cook’s Drug-eluting Peripheral Stent Performs Well in Large Study
Product page: Zilver PTX