Medtronic’s Abre Venous Stent Receives the US FDA’s Approval to Treat Venous Outflow Obstruction

October 27, 2020 Auto Bot approval, Medtronic, receives, Treat, Uncategorized, Us FDA 0

Shots:

  • The approval is based on ABRE clinical study assessing the Abre stent in 200 patients with iliofemoral venous outflow obstruction across the spectrum of deep venous obstruction including those with the post-thrombotic syndrome, NIVL & those who presented with an aDVT. The study also includes a challenging patient population, 44% of whom required stents that extended below the inguinal ligament into the CFV
  • The study resulted in meeting its 1EP of safety with a 2% rate of MAEs within 30 days and also met its 1EPs of efficacy with an overall primary patency rate of 88.0%, no stent fractures, and no stent migrations were reported in the study.
  • Abre venous self-expanding stent system is the device, indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction and has received CE Mark approval in April’2017

Click here ­to­ read full press release/ article | Ref: Medtronic | Image: elEconomista.es

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