TCT 2015: Two-year results from Medtronic’s In.Pact SFA trial

Two-year results from Medtronic‘s (NYSE:MDT) In.Pact SFA study showed that  the drug-eluting balloon was better than conventional balloon angioplasty, researchers said today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco. The 331-patient study randomized subjects 2:1 to either treatment with Medtronic’s In.Pact Admiral DEB or standard angioplasty. The primary efficacy endpoint was primary patency, while the primary safety endpoint was a composite of freedom from device- and procedure-related death after 30 days and freedom from target limb major amputation and clinically-driven target lesion revascularization at 2 years. Results from the study, which was also published in the Journal of the American College of Cardiology, showed that the DEB-treated arm had a much higher primary patency rate (78.9% compared with 50.1% for the control arm). Freedom from CD-TLR was 91.0% for the DEB group and 72.2% for the standard angioplasty group. For the 2-year composite safety endpoint, the DEB group showed an 87.4% rate, compared with a 69.8% rate for the control group. There were no device- or procedure-related deaths or major amputations in either group at 2 years, although mortality unrelated to the device or procedure was higher in the In.Pact Admiral group. “The 2-year data from In.Pact SFA demonstrates the continued superiority of drug-coated balloons for treating patients with superficial femoral artery disease compared ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Drug-Eluting Balloons Medtronic TCT 2015 Source Type: news