Medtronic ABRE Study initial results announced

Medtronic has announced that the ABRE clinical study assessing the safety and effectiveness of the investigational Abre™ venous self-expanding stent system in 200 patients in the US and Europe with iliofemoral venous outflow obstruction has met its primary safety and effectiveness endpoints.

The primary safety endpoint was met with a 2% rate of major adverse events in 30 days, and the 12 month primary effectiveness endpoint was met with an overall primary patency rate of 88%. A freedom from clinically driven target lesion revascularization rate of 92.4% was achieved through 390 days. Secondary endpoint results worth a mention were 100% device success achieved during the index procedure, no stent fractures and no delayed stent migration observed within 12 months and sustained and statistically significant improvements in quality of life measures and venous functional assessment scores at 12 months compared to baseline.

Simona Zannetti, M.D., vice president, Clinical Research, Medical Affairs, and Education, Medtronic Aortic, Peripheral, and Venous, said: “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. 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.”