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Medtronic Inc's In.Pact Falcon Drug-Eluting Balloon Yields Positive Outcomes in Small Coronary Arteries

Thursday, 23 May 2013 02:00am EDT 

Medtronic Inc announced that one year data from an Italian multicenter randomized controlled trial of the IN.PACT Falcon drug-eluting balloon from the Company demonstrate positive and durable clinical results with the novel angioplasty device in the treatment of stenotic de novo lesions in small coronary arteries, according to a presentation made here today to interventional cardiologists attending EuroPCR. The new data come from the BELLO (Balloon Elution and Late Loss Optimization) study, which enrolled 182 patients across 15 hospitals in Italy to evaluate the safety and effectiveness of two medical devices: Medtronic's IN.PACT Falcondrug-eluting balloon (DEB) and the Taxus drug-eluting stent (DES) from Boston Scientific Corp. Nearly two-thirds (64.9%) of the vessels treated in the BELLO study with the drug-eluting balloon were smaller than 2.25mm in diameter, for which no drug-eluting stent is currently available. The previously presented six-month angiographic outcomes of the BELLO study favored patients treated with the drug-eluting balloon. The study met its primary endpoint, late lumen loss at six months, with statistical significance showing superiority of the drug-eluting balloon over the drug-eluting stent (0.08 mm vs. 0.29 mm, p=0.001). Building on these data, the latest results from the BELLO study continue to demonstrate favorable outcomes for the IN.PACT Falcon drug-eluting balloon. 

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