Medtronic Post-Approval Study Confirms Safety of Drug-Coated Balloon

Medtronic reported positive results from a post-approval study of its IN.PACT AV DCB in patients with end-stage kidney disease. The trial showed that 70.2% of treated lesions remained open without reintervention or thrombosis after 12 months, closely matching results from the earlier pivotal study.

The study was required by the U.S. Food and Drug Administration to further assess long-term safety, particularly due to past concerns around paclitaxel-coated devices. These concerns have since eased, with regulators concluding the devices are unlikely to increase mortality risk.

The device also outperformed standard angioplasty, which showed lower patency rates. Additional findings indicated fewer repeat procedures and acceptable safety outcomes.

Overall, the results reinforce the device’s effectiveness and support its continued use in treating vascular access complications in kidney disease patients.

18-04-2026