FDA approves longer version of Medtronic’s In.Pact Admiral drug-coated balloon

Medtronic (NYSE:MDT) said today that the FDA approved a longer version of its In.Pact Admiral drug-coated balloon for treating peripheral artery disease. The 150mm-lenth device is available in 4mm, 5mm and 6mm diameters, the Fridley, Minn.-based company said. The FDA originally cleared the In.Pact Admiral DCB in January 2015, about 6 years after it won CE Mark approval in the European Union. “The expansion of In.Pact Admiral DCB to 150mm lengths demonstrates our commitment to providing meaningful technology to improve patient outcomes in a value-based healthcare environment,” peripheral unit general manager Mark Pacyna said in prepared remarks. “The In.Pact Admiral platform continues to show durable, consistent, and safe outcomes.” “The long lesion (10cm to 18cm) sub-group outcomes from the In.Pact SFA trial at 1 year demonstrated superiority over balloon angioplasty,” added co-principal investigator Dr. John Laird, of California’s U.C. Davis Medical Center. “The availability of the 150mm length sizes will expand proven treatment options to more patients.” Medtronic said the trial showed that the target lesion revascularization for the longer lesions was 5.3%, compared with 32.4% for patients treated with percutaneous transluminal angioplasty, with no device- or procedure-related deaths, no amputations and a 3.9% blood clot rate at 12 months (compared with 5.9% for the PTA cohort). In April, Medtronic released a bev...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Peripheral Artery Disease Source Type: news