The FDA approved the Zilver PTX drug-eluting stent for peripheral artery disease in November. Surgeons and vascular specialists had been waiting for the availability of this product in the United States for quite some time. VDM interviewed Gary Ansel, MD, on the FDA approval of the stent. Dr. Ansel was co-principal investigator for a randomized trial that studied the Zilver PTX stent.
“We’re one of the last developed countries to get approval even though we did the trial, so we’re very excited about the agency giving us approval to use the device in our patients and are excited about getting it in our hands,” said Dr. Ansel.
The first patient to be treated in the United States with Zilver PTX received the stent in December. And in the news lately we have seen coverage of surgeons being able to implant the stent in the United States. Yesterday, The Hour Online of Norwalk, CT, reported that the first surgeon in Connecticut had implanted a Zilver PTX stent in a patient. And in March, the University of Florida’s Academic Health Center, UF&Shands, announced that it had become one of 12 institutions nationwide initially approved to implant the Zilver PTX.
For a video interview on the study results with Dr. Ansel’s co-principal investigator, Michael Dake, MD, see “3-Year Results of the Zilver PTX Drug-Eluting Stent Trial.”