STEPS NEWS & BLOG

24 Nov FDA Approves First Drug-eluting Stent to Treat Peripheral Arterial Disease

On November 15, 2012, the U.S. Food and Drug Administration approved the Zilver PTX Drug-Eluting Peripheral Stent (Zilver PTX Stent), the first drug-eluting stent indicated to re-open a particular artery in the thigh (femoropopliteal artery) when narrowed or blocked as a result of peripheral artery disease (PAD).

The Zilver PTX Stent includes a small, metal mesh tube called a self-expanding metal stent that keeps an artery open. The stent is coated on its outer surface with the drug paclitaxel, a drug that helps prevent recurrent narrowing of arteries (restenosis). Existing options for treatment of PAD can include exercise, drug therapy, and other options within the artery, such as percutaneous transluminal angioplasty (PTA, or balloon angioplasty), or bare-metal stenting or surgical bypass.

Visit FDA's website for more information.