BERLIN – The Medical Device Regulation (MDR) that reforms the European Union's (EU) rules for earning a CE mark have knocked out another leg of the stool that supports U.S. manufacturers.
Already the number of Notified Bodies (NB) that grant the CE mark has been reduced from more than 80 to less than 60, and by 2019 that number is projected to drop to just 46 designated companies. (See BioWorld MedTech, April 19, 2017.)
PARIS – Protembis GmbH, based in Aachen, Germany, has begun the first-in-human trials for an intra-aortic filter that deflects away from the brain particles in the bloodstream set loose during transcatheter valve replacement (TAVR) procedures.
Patients with atrial fibrillation (AF) can be treated with a drug or else a device through a catheter ablation procedure, and the trend toward the device got a strong boost with the results from the Castle AF clinical trial presented at the meeting of the European Society of Cardiology (ESC).
One of the worst kept secrets at this year's meeting of the European Society of Cardiology (ESC) was confirmed when Dublin-based Medtronic plc confirmed positive outcomes for renal denervation in the treatment of moderate hypertension from the Spyral HTN-Off Med study during a Hot Line session.