InVera Medical announced recently that it picked up European approval for its minimally invasive device for delivering vein treatments. The Galway, Ireland-based company designed its device to help deliver treatment more effectively to diseased leg veins, including varicose veins. CE mark approval enables the marketing of the InVera Infusion … [Read more...] about InVera Medical wins European approval for vein infusion device
CE Mark
Peijia Medical seeks CE mark for its TEER system
Peijia Medical (Suzhou, China) announced today that it has submitted to receive a CE mark for its GeminiOne transcatheter edge-to-edge repair (TEER) system to treat mitral regurgitation. Paris-based HighLife, which recently secured a CE mark for its transcatheter mitral valve replacement (TMVR) system, is Peijia Medical's European partner in the … [Read more...] about Peijia Medical seeks CE mark for its TEER system
Medtronic wins CE mark for Affera Sphere-360 PFA catheter, reports first U.S. IDE cases
Medtronic (NYSE: MDT) announced two new milestones for its Affera Sphere-360 catheter for pulsed field ablation (PFA) procedures. First, the medtech giant received CE mark approval for the first-of-its-kind, all-in-one mapping and single-shot PFA catheter. It also completed the first cases for the paroxysmal AFib treatment system in the Horizon … [Read more...] about Medtronic wins CE mark for Affera Sphere-360 PFA catheter, reports first U.S. IDE cases
Abbott picks up CE mark for TactiFlex dual-energy ablation catheter
Abbott (NYSE:ABT) Abbott (NYSE: ABT)+ announced today that it received CE mark for its TactiFlex Duo Ablation Catheter, Sensor-Enabled, to treat AFib. Following approval, the company also reported the first commercial cases using the catheter in Europe, completed this week. Dr. Isabel Deisenhofer, head of the department of Electrophysiology at … [Read more...] about Abbott picks up CE mark for TactiFlex dual-energy ablation catheter
Boston Scientific gets European nod for Farapoint catheter
Boston Scientific announced recently that it received CE mark for its Farapoint pulsed field ablation (PFA) catheter. The regulatory nod, earned last week, allows the Marlborough, Massachusetts-based company to bring the newest PFA catheter in its electrophysiology portfolio to the European market. Farapoint treats right atrial flutter (AFL), … [Read more...] about Boston Scientific gets European nod for Farapoint catheter
AngioSafe emerges from stealth with FDA clearance for Santreva-ATK catheter
AngioSafe announced it has received FDA 510(k) clearance and CE marking for its Santreva-ATK endovascular revascularization catheter. San Jose, California–based AngioSafe designed the device for wire-free intraluminal crossing of chronic total occlusions (CTOs) while simultaneously compressing plaque and recanalizing vessels. Santreva-ATK enables … [Read more...] about AngioSafe emerges from stealth with FDA clearance for Santreva-ATK catheter
MicroPort Cardio’s Alwide Plus balloon catheter wins CE mark
MicroPort CardioFlow said its Alwide Plus balloon catheter has received CE mark approval, clearing the company to market the device in Europe. The approval makes Alwide Plus the company’s fourth product authorized in Europe, following the VitaFlow Liberty transcatheter aortic valve and delivery system, and the AnchorMan left atrial appendage … [Read more...] about MicroPort Cardio’s Alwide Plus balloon catheter wins CE mark
Abbott wins CE mark for Esprit drug-eluting, dissolving scaffold
Abbott (NYSE: ABT) announced today that it received CE mark for its Esprit BTK everolimus-eluting resorbable scaffold system. Esprit BTK offers treatment for people with peripheral artery disease (PAD) below the knee (BTK). Abbott designed it to keep arteries open and deliver the drug everolimus to support vessel healing. Following the therapy, … [Read more...] about Abbott wins CE mark for Esprit drug-eluting, dissolving scaffold
Anaconda Biomed wins CE mark for funnel catheter
Anaconda Biomed announced today that it received CE mark approval to commercialize its ANA5 funnel catheter in Europe. The company designed ANA5, a next-generation funnel catheter, to optimize mechanical thrombectomy. It maximizes clot capture with its vessel-matching diameter funnel. Simultaneously, it enables antegrade flow arrest and offers the … [Read more...] about Anaconda Biomed wins CE mark for funnel catheter
InspireMD wins CE Mark approval for CGuard Prime
InspireMD today announced it received CE Mark approval for its CGuard Prime carotid stent system for the prevention of stroke. The Miami-based company said the next-generation carotid stent system was developed based on physician feedback and features improved deliverability and deployment. It builds on the original CGuard design, which uses a … [Read more...] about InspireMD wins CE Mark approval for CGuard Prime
