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.
Ethicon has announced positive new data from the clinical development program for Evarrest fibrin sealant patch. More than 92% of patients treated during aortic reconstruction surgery with Evarrest achieved haemostasis on the first attempt within three minutes and maintained haemostasis throughout the duration of the surgery, compared with 33% for those treated with Baxter’s TachoSil patch and 46% for those treated with the standard of care—manual compression with or without an additional topical absorbable haemostat.
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.
Gore has completed primary enrolment in the Gore Excluder iliac branch clinical study, a prospective, multicentre, non-randomised, single-arm study designed to assess the safety and effectiveness of the Excluder iliac branch endoprosthesis in treating common iliac artery aneurysms or aorto-iliac aneurysms.
This year, the Charing Cross Symposium is launching the CX Live Case method. Thomas Zeller (Universitäts-Herzzentrum Freiburg – Bad Krozingen, Bad Krozingen, Germany), course director of the CX Live Peripheral Arterial Cases, will link the live case demonstrations from Bad Krozingen with topics to be discussed in the CX Main Programme – Peripheral Arterial Controversies at the Charing Cross Symposium 2015.
Boston Scientific will now distribute the Lutonix 035 drug-coated balloon in the USA under a limited distribution agreement reached with Bard. Terms of the agreement were not disclosed.
Data from a clinical trial assessing the safety and efficacy of the Castor Branched Aortic Stent-Graft System for the treatment of thoracic dissection has been released by MicroPort, the device’s manufacturer.
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