BD ’ s Bard updates on higher restenosis rate for LifeStream covered iliac stent

In this study, a PSVR of more than 2.4 suggests greater than 50% restenosis. At the time of the analysis, 155 subjects passed their nine-month visit and were evaluated for the primary and secondary endpoints. Restenosis through nine months following the procedure was among the factors measured in the study’s primary endpoint composite. Patients will be followed through 36 months. Bard won pre-market approval from the FDA for the LifeStream covered iliac stent for treating peripheral artery disease in June 2017. The PMA covers the treatment of atherosclerotic lesions in common and external iliac arteries with diameters of 4.5mm to 12.0mm and lesion lengths of up to 100mm, Murray Hill, N.J.-based Bard said. The LifeStream device has been on the U.S. market since that approval and in Europe since 2014. The post BD’s Bard updates on higher restenosis rate for LifeStream covered iliac stent appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Featured Stents Vascular BD Clearstream Technologies crbard Source Type: news