Already cleared by the FDA last year, the Tyrx Absorbable Antibacterial Envelope has won a CE mark for use with cardiac devices, and Medtronic has launched it in Europe.
Medtronic said that its recent CE mark for its CoreValve Evolut R System for transcatheter aortic valve implantation paves the way for the option to recapture or reposition artificial valves during heart surgery. The new feature is an advance in the relatively new arena of less-invasive heart surgery for patients who cannot withstand the rigors of open heart procedures.
Getting rid of the finger stick for diabetics while maintaining sufficient accuracy without calibration is a long-held industry goal and could prove a boon to patients.
Transluminal Technologies has announced it has received a CE mark for the bioresorbable Velox CD Vascular Closure Device for hemostatis, or stopping bleeding, in the thigh's femoral arterty following procedures involving needle puncture.
Cataracts are big business for Abbott. It's ready to roll out the latest in its line of implantable Tecnis lenses in Europe after recently receiving a CE Mark for the product, which will be used to treat cataract patients who may also have a diminished ability, due to aging, to focus on near objects (presbyopia).
Medtronic received a CE mark for the NC Euphora balloon catheter, a device designed to ensure that drug-eluting stents are fully apposed following implantation.
Elixir Medical has received a CE mark for its DESolve 100 novolimus-eluting bioresorbable coronary scaffold, named after its 100-micron strut profile and designed to degrade within an year.
Edwards Lifesciences won a CE mark for its innovative aortic valve system. European approval for the device comes at a critical moment for the company, as it attempts to strengthen its hold on foreign markets and stay a step ahead of its competition.
Boston Scientific nabbed a new CE mark that allows one of its esophageal stents to be used to treat narrowing of the esophagus caused by benign scar tissue--another win as the company seeks to restore steady revenue expansion after a years-long slump.
Stentys now has key CE mark approval to use its self-apposing stent to treat acute heart attacks in a broader class of patients.