WHITE PLAINS HOSPITAL

Medtronic receives FDA IDE approval for Prevail™ coronary paclitaxel drug-coated balloon (DCB) pivotal trial for in-stent restenosis (ISR) and de novo small vessel disease. The Prevail Global Study will enroll up to 1,205 patients across 65 global centers to assess safety and efficacy, including the first head-to-head randomized evaluation of two DCBs in the U.S. Data will support regulatory submissions in the U.S. and Japan.