Medtronic (NYSE:MDT) announced that it received FDA approval for its Abre venous self-expanding stent system.
Fridley, Minn.-based Medtronic’s Abre stent system received an indication for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction, which is also known as deep venous obstruction, according to a news release.
Abre is intended for permanent implants and utilizes an open-cell design with three offset connection points in an effort to allow for flexibility and stability during deployment. Medtronic says the system offers “a balance fo strength, flexibility and fatigue resistance.”
Approval arrives on the back of 12-month results from the medtech giant’s ABRE clinical study, which it presented at the 2020 Charing Cross Symposium in June.
The prospective, interventional, single-arm, multi-center, global trial with 200 subjects across 24 sites evaluated primary patency at 12 months for effectiveness and major adverse events within 30 days for safety. Patients included in the study ranged across the spectrum of deep venous disease, with subjects suffering from post-thrombotic syndrome (PTS), non-thrombotic iliac vein lesions (NIVL), and those with an acute deep vein thrombosis (aDVT).
According to the data, the study met its primary safety endpoint with a 2% (4 out of 200) rate of major adverse events within 30 days. The study recorded a primary patency rate of 88% (162 out of 184), meeting its effectiveness endpoint as well.
The study also recorded 100% device success during the index procedure, zero fractures and zero delayed stent migration within 10 months, and sustained and statistically significant improvements in quality of life measures and venous functional assessment scores at 12 months compared to baseline.
“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,” Medtronic VP & GM of its endovenous business Carolyn Sleeth said in the news release. “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.”