Category: CE Mark
OrbusNeich says its Combo dual-therapy stent is the 1st drug-eluting stent to win CE Mark approval in the European Union that combines traditional DES technology with the stimulation of healthy blood vessel growth.
OrbusNeich Medical said it got the green light in Europe for its Combo dual-therapy stent, calling it the 1st such device to both promote healthy tissue growth and prevent the stent from being engulfed by tissue growth.
Boston Scientific wins CE Mark approval in the European Union for its Guide imaging system, designed to aid in the placement of electrodes for deep-brain stimulation therapy to treat Parkinson's disease.
European regulators gave Boston Scientific (NYSE:BSX) the green light for its Guide 3D imaging system, touting it as the "world's first" deep-brain stimulation visualization system.
The Guide device is designed to create a simulated 3D map of the brain's electrical output, to help guide the placement of electrodes that deliver electrical pulses to the brain.
Medical device giant Medtronic says its European CE Mark is the 1st ever regulatory approval for valve-in-valve treatment for patients with degenerated surgical aortic valves.
European regulators for the 1st time approved a medical device for transcatheter valve-in-valve treatment in patients with degenerated surgical aortic valves, granting CE Mark approval to medtech titan Medtronic (NYSE:MDT) for its CoreValve and CoreValve Evolut devices.
Illinois healthcare giant Abbott lands European regulatory approval for the Xience Xpedition 48, which it calls the "world's longest coronary drug-eluting stent."
Healthcare giant Abbott (NYSE:ABT) won European regulatory approval for its Xience Xpedition 48, which it calls the world's longest coronary drug-eluting stent.
Biosensors International lands European approval for its BioMatrix NeoFlex drug-eluting stent.
Biosensors International (PINK:BSNRY) said it won a green light from European regulators for its BioMatrix NeoFlex drug-eluting stent, the latest in its DES line.
Medical device giant Medtronic announces CE Mark approval in the European Union and imminent commercial launch of its Export Advance thrombus removal system.
Medical device industry titan Medtronic (NYSE:MDT) announced today that it won CE Mark approval in the European Union for its latest thrombus removal system, the Export Advance aspiration catheter.
The new device, the latest in the Export family, will hit the shelves "soon" in Europe and other international markets, Medtronic reported.
Tryton Medical launches its side-branch short stent in Europe after winning CE Mark approval.
UPDATED May 17, 2013 with comment from Tryton CEO Shawn McCarthy.
Tryton Medical said it got the green light in Europe for its side-branch short coronary stent to treat bifurcation lesions in large vessels.
The new stent is 15mm, 3mm shorter in the main branch zone than the standard Tryton side-branch stent, the Durham, N.C.-based medical device company said.