Kalamazoo, Michigan, USA – March 07, 2017 – Stryker announced an early end to patient enrollment in the DAWN Trial, a clinical study designed to compare mechanical thrombectomy with the Trevo® Retriever plus medical therapy against medical therapy alone when initiated within six to 24 hours after time last known well. The independent Data Safety Monitoring Board (DSMB) recommended stopping study enrollment based on a pre-planned interim review of data from the first 200 patients, which concluded that multiple pre-specified stopping criteria were met. A final analysis of the data will be conducted upon completion of the remaining patient follow-up.
DUBLIN - Oct. 14, 2016 - Medtronic plc today announced that it has notified customers of a voluntary recall of certain lots of its Pipeline(TM) embolization device, Alligator(TM) retrieval device and X-Celerator(TM) hydrophilic guidewire. The recall also includes the stylet containing UltraFlow(TM) flow directed micro catheters and Marathon(TM) flow directed micro catheters. These products are produced, marketed and sold by Medtronic's Neurovascular business, which is part of the Brain Therapies division in the company's Restorative Therapies Group.