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CORRECTING And REPLACING Medtronic IN.PACT Drug-Eluting Balloon Studies Show Significant Benefit Of Novel Medical Device In Treating Narrowed Arteries

Please replace the release with the following corrected version due to multiple revisions.

The corrected release reads:


Randomized Controlled Trial Results Presented At EuroPCR Demonstrate Advantages Over Uncoated Angioplasty Balloons and Drug-Eluting Stents

Adding to the growing body of evidence on a novel interventional cardiovascular device, physicians presented today at EuroPCR 2012 the results of two multicenter, randomized controlled trials, the BELLO and PACIFIER studies, each one showing statistically significant advantages of using an IN.PACT drug-eluting balloon from Medtronic, Inc. (NYSE: MDT) over a corresponding conventional treatment for coronary and peripheral artery disease, respectively.

Medtronic IN.PACT drug-eluting balloons received CE (Conformité Européenne) mark in 2008 and 2009 and are available in many countries around the world. They are not commercially available in the United States.


The physician-initiated BELLO (Balloon Elution and Late Loss Optimization) study enrolled 182 patients across 15 hospitals in Italy to evaluate the Medtronic IN.PACT Falcon drug-eluting balloon versus the Taxus drug-eluting stent (DES) from Boston Scientific Corp. for safety and effectiveness in reducing late lumen loss in small-vessel coronary artery disease.

With both devices eluting paclitaxel, the late lumen loss (LLL) rate associated with the IN.PACT Falcon drug-eluting balloon (0.09 mm ± 0.38 mm) was superior to the Taxus DES (0.30 mm ± 0.44 mm) on the primary endpoint of in-stent/in-balloon LLL at six months (p=0.001).

“The results of the BELLO study show that Medtronic’s IN.PACT Falcon drug-eluting balloon may be a viable alternative to drug-eluting stents in treating small coronary vessels that have narrowed due to atherosclerosis, in addition to vessels with in-stent restenosis,” explained Dr. Antonio Colombo of Ospedale San Raffaele in Milan, co-principal investigator and presenter of the BELLO study. “Encouragingly, the angiographic findings of the independent core lab are concordant with the clinical results.”

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