The FDA has approved the Zilver PTX drug-eluting peripheral stent by Cook Medical for the treatment of peripheral arterial disease, the first drug-eluting stent approved for this indication.
The stent, which utilizes the drug paclitaxel, was supported by data from clinical trials along with extensive non-clinical testing that included biocompatibility, bench and animal testing.
In one trial, the Zilver PTX stent was compared with percutaneous transluminal angioplasty (PTA) in 479 patients with a single stenotic lesion in one or both of the femoropopliteal arteries. At 1 year, 83% of the stenoses were still open vs. 33% in the PTA group. Patients who had failed treatment with PTA were treated with the Zilver PTX stent and 90% of the stenoses treated were still open at 1 year vs. 73% in those treated with a bare-metal stent, according to a release issued by the FDA.
A second trial looked at outcomes in 787 patients who could be treated with up to four Zilver PTX stents for treating single or multiple lesions. At 1 year, stent fracture (1.54%) did not result in any detectable clinical consequences. The rate of stent thrombosis was 2.8% at 1 year and 3.5% at 2 years. The results also indicated the Zilver PTX stent to be at least as safe as PTA and significantly more effective, according to the release.
The stent is contraindicated in patients with stenoses that cannot be dilated to permit passage of the catheter or proper placement of the stent, patients who cannot receive recommended drug therapy due to bleeding disorders or women who are pregnant, breast-feeding or plan to become pregnant in the next 5 years.
This approval follows more than a year after the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee unanimously voted in favor of the stent.