November 18, 2017 |
Medtronic Drug-Coated Balloon for Peripheral Artery Disease Also Benefits Patients with Diabetes in Landmark Study
November 6, 2014  | 

Las Vegas, NV - For the treatment of peripheral artery disease in leg arteries above the knee, the IN.PACT Admiral drug-coated balloon from Medtronic provided a consistently favorable treatment effect in patients with diabetes in a landmark study of the investigational medical device, which is under review by the U.S. Food and Drug Administration (FDA) for approval.

This finding comes from a pre-specified subgroup analysis of patients with diabetes in the IN.PACT SFA Trial that was presented at the Vascular InterVentional Advances 2014 (VIVA 14) meeting during a late-breaking clinical trials session by Dr. Peter Schneider, chief of vascular surgery at Kaiser Foundation Hospital in Honolulu.

"Peripheral artery disease in patients with diabetes tends to be more advanced and complex and, as a result, more challenging to treat than it is in patients without diabetes," explained Dr. Schneider, a principal investigator of the IN.PACT SFA Trial. 
"While that tendency held true in this study, diabetes did not negate the magnitude of the difference in treatment effect. The patency rates were statistically significantly higher, by more than 20 percent, for all patients in the drug-coated balloon arm and for its diabetic patient subset."

IN.PACT SFA Trial - 12-Month Outcomes
Diabetes Subgroup Analysis Continue>

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