Sorin Group (BIT:SRN) said it won CE Mark approval in the European Union for adult patients to be treated with its Perceval sutureless aortic valve.
CE Mark
St. Jude’s Prodigy chronic pain neurostim device lands CE Mark
St. Jude Medical (NYSE:STJ) said it’s putting its Prodigy neurostimulation device on the market in Europe for patients with chronic back pain after winning CE Mark approval.
Medrobotics lands E.U. approval for Flex robotic surgery system
Massachusetts medical device maker Medrobotics won CE Mark approval in the European Union for its Flex System, a robot-assisted surgical device indicated for use in otolaryngology surgery.
Boston Scientific’s Ingevity MRI-safe cardiac pacing leads win EU nod
Boston Scientific (NYSE:BSX) said it won CE Mark approval in the European Union for its Ingevity pacemaker leads, designed to be safe during MRI scans.
Boston Scientific lands E.U. approval for Rebel bare-metal stent
Medtech titan Boston Scientific (NYSE:BSX) won European regulatory approval for its Rebel bare-metal stent, a drug-free version of its Promus Premier device.
DiFusion Technologies wins CE Mark for CleanFuze antimicrobial spinal implant
DiFusion Technologies said it secured CE Mark approval in the European Union for its CleanFuze antimicrobial spine implant line.
Georgetown, Texas-based DiFusion said the CleanFuze devices are designed to reduce surgical site infections using its antimicrobial orthobiologic polymer.
Reverse Medical lands Euro approval for neurovascular device
Reverse Medical secured European CE Mark approval for its UNO neurovascular embolization system, for obstructing blood flow in the blood vessels of the brain. The device also notched initial clinical use for intracranial specification.
Hypertension: Cordis lands Euro approval for Renlane renal denervation
Medtronic lands U.S., E.U. wins for miniature cardiac monitor
Boston Scientific lands expanded E.U. approval for WallFlex esophageal stent
Boston Scientific (NYSE:BSX) won expanded CE Mark approval for its WallFlex stent in the European Union, the company announced.
Tryton Medical lands added EU stent clearance
Tryton Medical said it won CE Mark approval in the European Union for its side-branch stent to treat left main coronary artery disease.
Durham, N.C.-based Tryton already has European clearance for the side branch stent, but only for treating bifurcated large-vessel lesions. The new approval makes the device the only stent cleared in Europe for the left main indication, according to a press release.