Medtronic plc (Dublin, Ireland) announced results from the ABRE clinical study assessing the safety and effectiveness of the investigational Abre venous self-expanding stent system in subjects with iliofemoral venous outflow obstruction. Medtronic said that the study met the primary safety and effectiveness endpoints.
The ABRE Study is a prospective, interventional, single-arm, multi-center, worldwide study, which included 200 subjects with symptomatic iliofemoral venous outflow obstruction from 24 sites throughout the U.S. and Europe.
In the U.S., Abre is an investigational device only and not yet approved for commercial use.