Medical device maker Cook Inc. plans to begin the first U.S. clinical trial of a drug-coated stent for leg arteries, company officials said.
The study beginning in September will examine whether drug-coated stents _ which have shown clinical success in treating coronary artery heart disease _ can be used for peripheral vascular disease in other parts of the body.
The trial will be the first clinical investigation approved by the U.S. Food and Drug Administration to study the effectiveness of a drug-eluting stent for peripheral arteries, officials said.
The trial will investigate the use of a stent coated with the drug paclitaxel in arteries in the leg.
"This is one of the most anticipated trials in years," Cook's stent trial's national principal investigator Michael D. Dake, told The Herald-Times for a story Thursday. He is chief of cardiovascular and interventional radiology at Stanford University School of Medicine.
Cook officials hope that the Destiny stents can help prop open collapsed arteries in the leg the same way they do in heart arteries.
Stents, small metal devices that act like scaffolds to prop open blocked arteries, have become successful at reducing the rate of re-blockage in both coronary and peripheral arteries.
At one time, Cook Inc. had a partnership with Boston Scientific and later with Guidant Corp. to develop a paclitaxel-coated coronary stent.
But Cook lost a series of legal battles with Boston Scientific that resulted in that company gaining exclusive rights to use paclitaxel on coronary stents. Boston Scientific's stent is now the top-selling device of its kind for patients with coronary artery disease, Cook officials said.
The market for drug-coated peripheral stents is nowhere near the estimated $5 billion market for drug-coated coronary stents, The Herald-Times reported.
David McCarty, spokesman for Cook, said the company has no plans to get back into the coronary stent business.
