ReFlow Medical said physicians in Germany are already using its Wingman35 and Spex crossing catheters, after the San Clemente, Calif.-based company won CE Mark approval for both devices for treating lesions in the peripheral vasculature.
CE Mark
Medtronic wins CE Mark for Tyrx cardiac device envelope
Boston Scientific wins CE Mark for Vercise brain stim device
Press Release: Symetis receives CE Mark approval for transfemoral transcatheter aortic heart valve system
LAUSANNE, SWITZERLAND – Symetis SA, the leading European developer of transcatheter aortic valve implantation (TAVI) systems, announced today the launch of ACURATE neo, its 15F compatible transfemoral TAVI system. Commercial implantations started early September after Symetis received CE Mark approval for ACURATE neo this summer.
TAVI: Symetis chases Medtronic and Edwards with E.U. win for Acurate neo heart valve
Stealthy Swiss device maker Symetis announced today that it’s launching commercial sales of its Acurate neo transfemoral transcatheter aortic valve implantation system, having just won CE Mark approval from European regulators.
Press Release: AcuFocus small-aperture IOL receives CE Mark for Europe
Irvine, CA – AcuFocus, Inc. (www.acufocus.com), the global leader in small-aperture technology, today announced that its extended depth of focus intraocular lens (IOL), the IC-8™ small aperture IOL, has achieved CE Mark (Conformité Européenne) approval in Europe. The lens is designed to provide exceptional visual quality across a broad range of vision for presbyopic patients with cataracts.
Vision: AcuFocus lands E.U. approval for next-gen eye implant
California-based device maker AcuFocus is taking its next-generation intraocular lens to Europe after winning regulatory approval to treat cataract patients with near vision loss, or presbyopia.