Angiodynamics Inc. received CE mark approval for its Auryon atherectomy system which treats peripheral artery disease, including critical limb ischemia and in-stent restenosis. The regulatory clearance expands the company’s global reach as it sees increasing revenues from sales of the device.
Elixir Medical Corp. reported positive 12-month data from the Infinity-Swedeheart trial that compared its Dynamx coronary bioadaptor system to Medtronic plc’s Resolute Onyx zotarolimus drug-eluting stent in patients requiring percutaneous coronary intervention with coronary artery disease.
In what represents Vienna, Austria-based Valeriot GmbH’s first patenting, its founder and CEO, Michael Flatscher, describes their invention of a device, Autovein, for use in no-touch vein harvesting which overcomes the issues faced with traditional vein harvesting techniques which are laborious, prone to complications and challenging to master.
Hope for definitive resolution of the controversy about the superiority of transcatheter edge-to-edge repair of mitral valves over medical therapy in individuals with symptomatic heart failure and functional mitral regurgitation were dashed at the European Society of Cardiology meeting this weekend.
Boston Scientific Corp. obtained a CE mark for its latest self-expanding transcatheter aortic valve replacement technology, the Acurate Prime, opening up a new access point for increased sales and profitability in its structural heart division this year.
Researchers from the University of Arkansas have filed for protection of their development of systems and methods to aid angioplasty procedures in coronary artery bifurcations, where a major artery splits into smaller blood vessels.
Since the U.S. FDA’s approval of the first pulsed field ablation (PFA) system in the U.S. last December, PFA technology has rapidly reconfigured the electrophysiology market in the U.S. and ramped up sales of PFA systems in Europe.
The clearance by the U.S. FDA of Healthccsng V2.0, an artificial intelligence cardiac solution developed by Nano-x Imaging Ltd.’s (Nanox) subsidiary, Nanox.AI, is highly “significant” for the company and will offer “substantial” benefits to cardiology departments by significantly enhancing the detection of coronary artery calcification, Erez Meltzer, Nanox CEO told BioWorld.
The U.S. FDA recently announced that Inari Medical Inc. issued a recall that corrects the instructions for use for roughly 2,500 units of the Clottriever XL catheter due to reports of device entrapment in the lung.
Johnson & Johnson aims to add a fourth cardiac business to its portfolio in less than two years with the acquisition of V-W aveLtd., which makes the Ventura interatrial shunt system for the treatment of heart failure. J&J will pay $600 million up front and an additional $1.1 billion contingent on meeting specified regulatory and commercial milestones. The deal is slated to close before the end of the year.