The first drug-coated angioplasty balloon approved by the FDA showed superior primary patency over standard balloons at 12 months, but some industry analysts are skeptical about longer-term data. According to 12-month results published in The New England Journal of Medicine, the Lutonix 035 drug-coated balloon percutaneous transluminal angioplasty (PTA) catheter from C. R. Bard (Murray Hill, New Jersey) demonstrated superior primary patency over standard PTA in the LEVANT 2 study. LEVANT 2 was a single-blind randomized multicenter trial. Read More
