Abre system has been approved for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction
Medical technology firm Medtronic has secured approval from the US Food and Drug Administration (FDA) for its Abre venous self-expanding stent system.
The Abre venous self-expanding stent system has been approved for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction or otherwise called deep venous obstruction.
The current approval was based on 12-month data from the ABRE clinical study, which evaluated the safety and efficacy of the investigational Abre stent in 200 patients with iliofemoral venous outflow obstruction across the spectrum of deep venous obstruction.
Medtronic’s trial included patients with post-thrombotic syndrome, non-thrombotic iliac vein lesions (NIVL), as well as with an acute deep vein thrombosis (aDVT). It also included a challenging patient population who required stents that extended below the inguinal ligament into the common femoral vein (CFV).
According to the company, the trial achieved its primary safety endpoint with a 2.0% rate of major adverse events (MAEs) within 30 days, as well as met its 12-month primary effectiveness endpoint with an overall primary patency rate of 88.0%.
Abre self-expanding stent system serves as a permanent implant
Designed to serve as a permanent implant, Abre uses an open-cell design with three off-set connection points to facilitate flexibility and stability during deployment.
The self-expanding stent system also provides a balance of strength, flexibility, and fatigue resistance, said the company.
In April 2017, the company secured CE mark approval for the Abre system for use in the iliofemoral veins to treat symptomatic venous outflow obstruction.
Medtronic cardiac and vascular group’s endovenous business general manager and vice president Carolyn Sleeth said: “With Abre, our goal was to create a dedicated venous stent that combined a balance of the key characteristics necessary to treat patients with a broad spectrum of deep venous obstruction.
“We are excited to bring Abre to the U.S. market, which we believe will provide both physicians and patients with a new option backed by clinical evidence to treat this disease safely and effectively.”
In September, Medtronic secured breakthrough device status from the FDA for its TYRX absorbable antibacterial driveline wrap device.