Medtronic plc, a global leader in healthcare technology, today announced it has received CE (Conformité Européenne) Mark for the Evolut™ FX+ transcatheter aortic valve implantation (TAVI) system, the company’s latest Evolut TAVI system for the treatment of symptomatic severe aortic stenosis. This follows the recent United States Food and Drug […]
Tag: CE
CARMAT Receives the CE Marking for Its Total Artificial Heart
CE marking allows the company to market its total artificial heart in the EU as a bridge to transplant Virtual press conference scheduled on January 6, 2021 PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an […]
HeartStitch® Inc. has received CE Mark for Its Suture Based Trans-Apical Access and Closure
ZWICKAU, Germany, April 12, 2018 /PRNewswire/ — HeartStitch® Trans-Apical Access and Closure device provides safe and effective percutaneous trans-apical access for structural heart procedures and reliable closure. The proven suture-based technique emulates surgical closure without the need for open heart surgery or limited thoracotomy access (open surgical access to the heart between the ribs) when […]
Avinger Receives CE Marking Approval for In-Stent Restenosis Treatment Indication With Pantheris Image-Guided Atherectomy
REDWOOD CITY, Calif., Sept. 26, 2017 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for Peripheral Artery Disease (PAD), today announced Conformité Européenne (CE) Marking approval for treating in-stent restenosis with the Pantheris® Lumivascular atherectomy system. In-stent restenosis occurs when a previously blocked artery treated with […]
Medtronic Announces CE Mark and European Launch of CoreValve(TM) Evolut(TM) PRO Transcatheter Valve with Advanced Sealing
DUBLIN – July 31, 2017 – Medtronic plc (NYSE:MDT) today announced CE (Conformité Européenne) mark and European launch of the CoreValve(TM)Evolut(TM) PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at intermediate, high or extreme risk for open heart surgery. Clinical data for the Evolut PRO valve […]
Cerus Endovascular Receives CE Mark Approval For The Contour Neurovascular System For The Treatment Of Intra-Cranial Aneurysms
FREMONT, Calif. and OXFORD, United Kingdom, July 6, 2017 /PRNewswire/ — Cerus Endovascular Ltd. today announced that it has received CE Mark approval for the commercial sale of its Contour Neurovascular System for the treatment of intra-cranial aneurysms (IAs) across the European Union (EU). The Contour Neurovascular System is a unique, fine mesh braid […]
Shockwave Medical Snags CE Mark for Coronary Lithoplasty System
FREMONT, Calif.–(BUSINESS WIRE)–Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today announced conformité européenne (CE) Mark for the company’s Coronary Lithoplasty® System for the treatment of calcified plaque in conjunction with stenting in patients with coronary artery disease. The Shockwave Medical Coronary Lithoplasty System is an innovative […]