Medtronic Abre stent receives US FDA approval to treat ... | 合法醫療器材資訊網

2020年10月26日—Aself-expandingstentsystem,Abreisintendedforpermanentimplantandutilisesanopen-celldesignwiththreeoff-setconnectionpointsto ...

Medtronic today announced it has received US Food and Drug Administration (FDA) approval for the Abre venous self-expanding stent system. This device is indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction.

The FDA approval is based on 12-month results[1] from the ABRE clinical study, presented at the 2020 Charing Cross Symposium. The ABRE study assessed the safety and effectiveness of the investigational Abre stent in 200 patients with iliofemoral venous outflow obstruction across the spectrum of deep venous obstruction including those with post thrombotic syndrome, non-thrombotic iliac vein lesions (NIVL), and those who presented with an acute deep vein thrombosis (aDVT).

The study also included a challenging patient population, 44% (88/200) of whom required st...