… peripheral artery disease, a condition which is very different than thrombotic events. The commenter reported that percutaneous ultrasonic fragmentation procedures using the EKOS TM device typically involve leaving the EKOS TM device in the body for multiple hours and in many ca…

… peripheral artery disease, a condition which is very different than thrombotic events. The commenter reported that percutaneous ultrasonic fragmentation procedures using the EKOS TM device typically involve leaving the EKOS TM device in the body for multiple hours and in many ca…

… instead interquartile ranges ( 90 FR 18099 ). The applicant summarized adverse events reported in Cauchy et al. (2011) and Crooks et al. (2022), as well as a multicenter retrospective cohort study and the AURLUMYN TM prescribing information. The applicant also referenced the NDA…