Medtronic has received FDA approval for its new deep venous obstruction solution, the Abre venous self-expanding stent system.
Approval came after the FDA reviewed data from the ABRE clinical study, which focused on 200 patients with iliofemoral venous outflow obstruction who were treated with the Abre system. The rate of major adverse events was 2% after 30 days, according to that study, and its overall primary patency rate was 88% after a full year. No stent fractures or stent migrations were reported during the treatment of those 200 patients.
“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,” Carolyn Sleeth, vice president and general manager of Medtronic’s endovenous business, said in a statement. “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.”
“Patients with deep venous obstruction are often younger, therefore it's critical to have a venous stent that is not only safe and effective, but also strong and flexible,” added Erin Murphy, MD, global principal investigator for the ABRE clinical study and director of the Atrium Health Sanger Heart & Vascular Institute’s venous and lymphatic program in Charlotte, North Carolina. “With FDA approval, we now have this important tool in our arsenal to treat patients with even the most challenging of deep venous lesions.”
The system received CE mark approval back in 2017.
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