Daiichi Sankyo has announced that Swissmedic, the regulatory authority of Switzerland, has granted approval of Lixiana (edoxaban), an oral, once-daily selective factor Xa inhibitor, for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. Simultaneously, Lixiana has received marketing authorisation in Switzerland for the treatment of adult patients with venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), following previous treatment with fractionated or unfractionated heparin for five days, as well as for the prevention of recurrent VTE.
Inari Medical has treated the first patient with its FlowTriever infusion aspiration system. The FlowTriever system received 510(k) marketing clearance from the US Food and Drug Administration (FDA) in February to treat emboli in the peripheral vasculature.
CryoLife has provided an update on its ongoing litigation with CR Bard and some of its subsidiaries regarding PerClot. The US District Court for the District of Delaware has allowed CryoLife’s declaratory judgement lawsuit against CR Bard’s Medafor subsidiary to proceed. The court also granted Medafor’s motion for a preliminary injunction with respect to CryoLife’s marketing and sale of PerClot Topical in the USA. CryoLife is currently awaiting the court’s order, which it expects will provide details regarding the scope of the injunction.
ArtVentive Medical has announced the first use of its Endoluminal Occlusion System (EOS) in the USA at The Johns Hopkins Hospital in Baltimore, where Kelvin Hong and Anobel Tamrazi performed a splenic artery occlusion using the device.
At the Leipzig Interventional Course (LINC, 27–30 January, Leipzig, Germany), Michael Lichtenberg, chief of the Vascular Center Klinikum Arnsberg, Arnsberg, Germany, presented information about a new balloon dilatation catheter that allows a targeted injection of fluids during percutaneous transluminal angioplasty.
ClearFlow is currently exhibiting its PleuraFlow Active Clearance Technology system at the 34th annual Association of Physician Assistants in Cardiovascular Surgery (APACVS) meeting (1–4 March, Las Vegas, USA). PleuraFlow will also be displayed at the Maquet Medical Systems USA booth until 4 March. Maquet is the exclusive distributor of ClearFlow’s PleuraFlow system in the USA.
Cardinal Health announced on 2 March 2015 plans to acquire Johnson & Johnson’s Cordis business, a global manufacturer of cardiology and endovascular devices, for US$1.944 billion in cash, or approximately US$1.594 billion, net of the present value of tax benefits.
Gore reports that more than 2,500 patients have been enrolled in the Gore global registry for endovascular aortic treatment (GREAT). The registry is part of Gore’s dedication to post-market surveillance and monitoring long-term device performance in an effort to improve clinical practice and patient outcomes.
Researchers from CBSET have defined the optimal tissue debulking protocol for treating in-stent restenosis with Boston Scientific’s Jetstream Navitus atherectomy device. The findings were disclosed at the CRT 2015 annual scientific meeting (21–24 February) in Washington, DC, USA.
Biotronik has announced the presentation of promising data from the iliac arm of the BIOFLEX-I clinical trial at the Cardiovascular Research Technologies conference (21–24 February, Washington, DC, USA).
Sanford Health, Sioux Falls, USA, is enrolling patients for a clinical trial using a less-invasive method to treat thoracoabdominal aortic aneurysms. Patrick Kelly, medical director of Sanford Vascular Services, Sanford Wound Clinic and the Sanford Advanced Aortic Program, Sioux Falls, USA, developed the investigational device and associated surgical procedure.
The US Food and Drug Administration (FDA) has approved Medtronic’s VenaSeal closure system to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent.
The results of the BAROSLEEP study, published in the December issue of the European Journal of Vascular and Endovascular Surgery, show that microstructural white matter damage is associated with poor outcome in peripheral arterial disease patients with claudication requiring surgical revascularisation. Timo Laitio, Division of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital, Turku, Finland, the study lead investigator, spoke to Vascular News about the study and its clinical implications.
Theodosios Bisdas, Department of Vascular Surgery, University Clinic & St Franziskus Hospital of Munster, presented in-hopsital outcome results from the real-world, critical limb ischaemia CRITISCH registry at the Leipzig Interventional Congress (LINC, 27–30 January, Leipzig, Germany). In the study, more than 50% of patients treated for critical limb ischaemia in Germany underwent endovascular therapy.
The US Centers for Medicare and Medicaid Services has approved a pass-through payment for Bard’s Lutonix drug-coated balloon under the Medicare hospital outpatient prospective payment system. This approval follows a unanimous favourable recommendation from the Food and Drug Administration (FDA)’s Circulatory Systems Devices Advisory Panel, which voted 9 to 0 on each question of safety, efficacy and benefit/risk.
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