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Monday, October 26, 2020

Medtronic's Abre venous stent receives FDA approval

  • Medtronic (MDT -2.5%) has received U.S. FDA approval for the Abre™ venous self-expanding stent system for the patients with symptomatic iliofemoral venous outflow obstruction, also known as deep venous obstruction.
  • The FDA approval is based on 12-month results from the ABRE clinical study, presented at the 2020 Charing Cross Symposium.
  • The study also met its 12-month primary effectiveness endpoint with an overall primary patency rate of 88% (162/184).
  • Despite the challenging patient population, no stent fractures and no stent migrations were reported in the study.
  • https://seekingalpha.com/news/3625790-medtronics-abre-venous-stent-receives-fda-approval

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