Medtronic's In.Pact Falcon DEB Yields Positive Outcomes in Small Coronary Arteries

May 23, 2013—One-year data from an Italian multicenter, randomized, controlled trial of the In.Pact Falcon drug-eluting balloon (DEB) (Medtronic, Inc., Minneapolis, MN) demonstrate positive and durable clinical results with the device in the treatment of stenotic de novo lesions in small coronary arteries, according to a presentation at EuroPCR in Paris, France.

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 Falcon DEB and the Taxus drug-eluting stent (DES) from Boston Scientific Corporation (Natick, MA). Nearly two-thirds (64.9%) of the vessels treated in the BELLO study with the DEB were smaller than 2.25 mm in diameter, for which no DES is currently available.

The previously presented 6-month angiographic outcomes of the BELLO study favored patients treated with the DEB. The study met its primary endpoint, late lumen loss at 6 months, with statistical significance showing superiority of the DEB over the DES (0.08 mm vs 0.29 mm; P = .001).

Building on these data, the latest results from the BELLO study continue to demonstrate favorable outcomes for the In.Pact Falcon DEB. At 1 year, the clinical outcomes of major adverse cardiac events (MACE), myocardial infarction (MI), and target lesion revascularization (TLR) were statistically similar for both devices—for MACE: DEB = 10%; DES = 18.5% (P = .31); for MI: DEB = 1.1%; DES = 5.5% (P = .1); for TLR: DEB = 4.4%, DES = 9.8% (P = .25).

"The BELLO study shows that treating de novo coronary lesions with the In.Pact Falcon drug-eluting balloon is a viable option, with strong clinical outcomes to 1 year," said Azeem Latib, MD, in the company's press release. Dr. Latib is with San Raffaele Hospital and EMO-GVM Centro Cuore Columbus in Milan, Italy, and was the presenter of the new data. "The 1-year results suggest that this novel angioplasty device should not necessarily be limited to only treating in-stent restenosis in coronary arteries. They also suggest that lesions in relatively small coronary arteries are possibly a strong application for this particular device."

The Medtronic In.Pact Falcon DEB received CE Mark approval in 2009 and is available in many countries around the world. It is not commercially available in the United States, the company advised.