Daiichi Sanyoko has announced the results from their Hokusai-VTE CANCER trial evaluating the direct oral anticoagulant edoxaban for treatment of venous thromboembolism (VTE) in cancer patients.
The European Board of Phlebology has announced that the European Union of Medical Specialists (UEMS) have adopted the European training requirements presented by Jean-Jérôme Guex, president of the newly created Board. The development is the result of a European inter-speciality cooperation as the latest step in a process that started in 2015 with a meeting of the Multidisciplinary Joint Committee in Phlebology at the initiative of several UEMS specialties, including vascular surgery, vascular medicine, dermatology, radiology and general surgery, to elect a board of Phlebology.
Global specialist healthcare company BTG has highlighted the commencement of the KNOCOUT PE study. The KNOCOUT PE study will measure how hospitals and patients are benefitting from a new standard of care in the treatment of pulmonary embolism utilising the company’s EKOS therapy with faster and safer protocols, following the encouraging results of the OPTALYSE PE study.
At the THE VEINS at VIVA meeting (10–11 September, Las Vegas, USA), Esther Kim (Vanderbilt University Medical Center, Nashville, USA) gave a presentation on venous thrombosis in unusual locations, noting that such thromboses tend to occur in younger patients and those with malignancy, and that thrombophilia has a role in most cases and testing for it may be considered.
At THE VEINS at VIVA meeting (10–11 September 2017, Las Vegas, USA), James Froehlich, University of Michigan, Ann Arbor, USA, reviewed guidelines on the management of superficial venous thrombosis (SVT) and emphasised the importance of performing duplex ultrasound in the examination, assessing clot location and extent, considering the risk factors for recurrence and development of deep vein thrombosis (DVT), and discussing with the patient their options on the use of anticoagulants.
The US Centers for Medicare and Medicaid Services (CMS) has posted the 2018 Medicare Physician Fee Schedule (CMS-1678-F) and Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (CMS-1678-FC). As part of the final rulings, healthcare providers will now be able to bill for VenaSeal utilising the new CPT codes 36482 and 36483. These new codes will take effect on 1 January, 2018.
The first patient has been enrolled in Bolton Medical’s RelayPro US Food and Drug Administration (FDA) Phase II clinical trial.
The first US patient has been treated with VentureMed Group’s Flex scoring catheter. The catheter is used to treat patients with end-stage renal disease.
iVascular SLU has announced the initiation of the TINTIN trial, evaluating the combined therapy of Luminor drug-coated balloon (DCB) and iVolution self-expandable stent.
Preliminary 30-day data from the PRELUDE trial investigating the use of the Serranator Alto percutaneous transluminal angioplasty (PTA) serration balloon catheter (Cagent Vascular) have shown 100% technical success and good effectiveness in moderate to severe calcification in the superficial femoral artery. The acute results show that the balloon can achieve low residual stenosis, and final six-month results are expected by the end of 2017.
Endologix has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence a confirmatory clinical study (EVAS2) to evaluate the safety and effectiveness of the Nellix endovascular aneurysm sealing system (EVAS) for the treatment of infrarenal abdominal aortic aneurysms.
CryoLife has entered into a definitive agreement to acquire Jotec AG. A press release states that the combination of CryoLife and Jotec will create a company “with a broad and highly competitive product portfolio focused on aortic surgery, and will position CryoLife to compete strongly in the important and growing endovascular surgical markets.”
Medtronic has received US Food and Drug Administration (FDA) approval for the Endurant II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients with neck lengths down to 4mm and <=60 degrees infrarenal angulation when used in combination with the Heli-FX EndoAnchor system. The expanded indication enables the Endurant II/IIs stent graft to be used in conjunction with the Heli-FX EndoAnchor system to treat a wider range of patients with short, hostile aortic neck anatomies, independent of renal stenting.
The US Centers for Medicare and Medicaid Services (CMS) has determined that there is now sufficient evidence to cover supervised exercise therapy for the treatment of intermittent claudication. This decision will likely provide a boost to supervised exercise therapy programmes in the USA, with US physicians now enjoying greater flexibility when considering approaches for intermittent claudication. However, supervised exercise therapy is not without its obstacles. Vascular News spoke to an international selection of experts, who noted that poor patient adherence, lack of funding and physician disinterest still represent barriers to widespread adoption of such programmes.
Endologix has appointed John Onopchenko as the company’s chief operating officer, effective as of 30 October, 2017. Onopchenko will be responsible for managing Endologix’s manufacturing, supply chain, and quality organisations.
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