Medtronic's Evolut FX TAVI System Gets CE Mark

Medtronic today announced that its latest iteration of the Evolut TAVI/TAVR system, the Evolut ™ FX, has received the CE (Conformité Européenne) Mark. Although medical devices often are approved in Europe prior to US approval, the Evolut FX did the opposite: it garnered US FDA approval two years ago. Today's announcement means that this newest and most advanced transcatheter platform for treating severe aortic stenosis will now be available in Europe and beyond.
Source: News from Angioplasty.Org - Category: Cardiology Source Type: news