Medtronic reports data from Resolute stent studies
Medtronic Inc. said Monday that a clinical study shows its Resolute drug-coated stent is as effective as Abbott Laboratories' Xience V stent in treating lesions caused by coronary artery disease.
The world's largest medical device company reported results from two studies at a meeting of the American College of Cardiology in New Orleans. Medtronic said that in a study involving 2,292 patients, the Resolute stent and Xience V had similar rates of failure in the lesions they were implanted to treat. In a separate study, Medtronic said Resolute patients had lower rates of target lesion failure and few needed additional surgical procedures.
Stents are mesh tubes that prop arteries open. Stents like Resolute and Xience V are coated with drugs designed to stop the blood vessels from closing.
In the two-year study, the rate of target lesion failure for Resolute patients was 11.2 percent, compared to 10.7 percent for Xience V patients. The rates were statistically identical. The rates were also statistically similar after one year.
Medtronic said 4.7 percent of patients in the one-year study experienced target lesion failure. The company said 34 percent of patients in the study had diabetes, which puts them at risk for more complications.
European Union regulators approved Resolute in October 2007, but the stent is not on the market in the U.S. Medtronic said it expects the Food and Drug Administration to make a decision on its marketing application for Resolute in the first half of 2012.
Shares of Minneapolis-based Medtronic fell 15 cents to $39.35 in afternoon trading.