The Abre stent system is designed for treating patients with iliofemoral venous outflow obstruction. 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 data presented virtually at the 2020 Charing Cross Symposium, 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, according to a news release.
“Our goal with the ABRE study is to generate evidence supporting the performance of the Abre stent in patients with broad indications for iliofemoral venous obstruction,” Medtronic aortic, peripheral & venous segment VP of clinical research, medical affairs & education Dr. Simona Zannetti said in the release. “This includes patients with an initial presentation of acute deep vein thrombosis, which is a unique differentiator of this study.
“We are very encouraged by the one-year results and look forward to sharing the data broadly as we seek to expand commercialization globally.”
Abre currently has CE Mark approval in Europe as of April 2017, but remains an investigational device that has not obtained approval in the U.S.