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).
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.
In the first-line treatment of non-resectable metastatic colorectal cancer, the preliminary analysis of the SIRFLOX study results does not show a statistically significant improvement in overall progression-free survival ie, at any site. However, the study does show a statistically significant improvement in progression-free survival in the liver.
Bracco Imaging, through its business unit Bracco Injeneering SA, has announced the availability of its EmpowerCTA+, an advanced engineering contrast injection system that puts the radiologic technologist in control in the computed tomography suite.
Lombard Medical has announced that it has received approval for the AorFlex delivery system from the Japanese Ministry of Health, Labour and Welfare. Commercial sales will follow reimbursement approval, which the company anticipates receiving in April, and the company will receive and ship a significant stocking order in advance of the commercial launch.
Avinger announced on 12 March that it has completed enrolment of its VISION clinical study, which is designed to evaluate the safety and efficacy of the company’s Pantheris system. According to Avinger, the Pantheris catheter is the only device to combine directional atherectomy with real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.
The Protégé GPS self-expanding peripheral stent system (Medtronic) has received approval from the FDA for the treatment of stenotic lesions of the common and external iliac arteries. The news follows the nine-month results of the DURABILITY Iliac study, which were presented at the VIVA conference in Las Vegas in November 2014.
A study published in the European Journal of Vascular and Endovascular Surgery shows that in the carotid arteries, stent malapposition is more frequent with closed-cell stents while plaque prolapse is more common with open-cell stents. Gianmarco de Donato, Department of Surgery, Vascular and Endovascular Surgery Unit, University of Siena, Siena, Italy, explains the rationale behind the study, its implications and future directions.
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