FDA Approves PALMAZ® for Renal Artery Stenosis

Since 1991, endovascular specialists have been using PALMAZ (Cordis Corporation, a Johnson & Johnson company, Miami, FL) stents to treat iliac and transhepatic biliary blockages. The FDA has recently approved the Cordis PALMAZ® Balloon-Expandable Stent for the treatment of renal artery stenosis in patients who underwent angioplasty with suboptimal results. The FDA approval, which was the first for a stent used in renal artery stenosis, was based on the 2-year findings of ASPIRE2, a multicenter, prospective, nonrandomized trial that began in December 1997. The ASPIRE2 trial evaluated 208 patients at 23 sites for 24 months.

The FDA-approved expanded indication for the PALMAZ stent includes use of 10-, 15-, and 20-mm-long stents in patients with atherosclerotic disease of the renal artery or arteries following suboptimal percutaneous transluminal renal angioplasty of a de novo or restenotic lesion.