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.
Three-year follow-up results of patients treated with the Supera stent show that nominal deployment or slight compression of the device delivers the best outcomes in terms of durability, and that severe stent elongation provides the lowest durability through three years. With nominal deployment, the freedom from reintervention rate was 97% at one year and 94% at three years – a “minimal decrease”, according to Lawrence Garcia, who presented the results at the VEITHsymposium (18–22 November, New York, USA).
Lombard Medical has released efficacy and safety data from the two-year follow up of the US PYTHAGORAS pre-marketing approval (PMA) trial of Aorfix, the first and only endovascular stent graft with global approvals for the treatment of patients with aortic neck angulations up to 90 degrees.
Studies presented at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition compare new and standard-of-care treatments for blood clots and further illuminate clot risks in vulnerable populations, such as cancer patients.
Vascular Flow Technologies have presented study results at the 41st Annual VEITH Symposium on Vascular and Endovascular Issues in New York, showing a 30% increase in one-year success for infrainguinal vascular bypass surgery in patients who received a Spiral Flow™ Graft compared to those who received a standard polytetrafluoroethylene (PTFE) graft.
VIVA Physicians, Inc. announced that 4-year results from a prospective, single-arm, multicenter trial conducted at 26 sites in the United States to evaluate the Endurant stent graft system (Medtronic, Inc.) for the treatment of abdominal aortic aneurysms (AAAs) were presented by Edward Woo, MD, during a late-breaking trials session at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada.
VIVA Physicians, Inc. announced that Michael Dake, MD, presented the trial plan and reported preliminary findings from the Gore TAG Thoracic Branch Zone 2 Feasibility Study during a late-breaking trials session at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada.
Hansen Medical, Inc. announced that the company´s Magellan 6-F robotic catheter has received European CE Mark approval for use in the peripheral vasculature. This allows the company to market the Magellan 6-F device in Europe and other countries that recognize the CE Mark. In February 2014, the company announced US Food and Drug Administration 510(k) clearance for the Magellan 6-F robotic catheter, which is commercially available in the United States.
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