Avinger announced on 13 October 2015 interim six-month results for its VISION clinical trial. VISION is designed to evaluate the safety and effectiveness of the Pantheris system to perform directional atherectomy while for the first time ever allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.
Endologix announced on 13 October 2015 that it has received FDA approval for the AFX2 Bifurcated Endograft System for the treatment of abdominal aortic aneurysms. This new device is the latest innovation in the AFX Endovascular AAA family of products. Endologix plans to highlight AFX2 at the 2015 VEITHsymposium taking place 17–21 November in New York, with a commercial launch in the USA expected to begin in the first quarter of 2016.
A retrospective multicentre study has concluded that internal iliac aneurysms that are less than 4cm in diameter have a low risk of rupture, and suggested that the threshold for elective treatment of the condition may be safely increased from 3cm (current practice) to 4cm.
In-stent restenosis patients with severe claudication or critical limb ischaemia should be treated with drug-coated technologies if they present with focal lesions and with a mechanical block such as covered stents if they have diffuse lesions or occlusion, according to Koen Deloose, Dendermonde, Belgium.
Cardinal Health has announced that it has completed the acquisition of Johnson & Johnson’s Cordis business for US $1.944 billion. Planning has been ongoing since the acquisition announcement in early March 2015, and the integration is off to a successful start with management teams in place worldwide. With the Cardinal Health acquisition of Cordis, devices such as the Cordis S.M.A.R.T Vascular Stent Systems are now part of the Cardinal Health portfolio.
Dedicated venous stents can be effectively used to relieve outflow obstruction at one year following thrombotic disease in both the acute and chronic setting, according to the prize-winning research presented at the European Venous Forum (EVF; 2–4 July, Saint Petersburg, Russia). Prakash Saha, King’s College London, Guy’s and St Thomas’ NHS Foundation Trust, London, UK, said, however, that as deep venous reconstruction is challenging, complex cases may require reintervention or adjunctive procedures.
The City University of New York (CUNY), Lawrence Livermore National Laboratory, and Near Infrared Imaging, have released the “Vein-Eye” camera. The Vein-Eye provides enhanced visualisation of veins when drawing blood or placing IVs in a patient’s arm or hand. The Vein-Eye is a non-contact medical device that displays real-time video for accurate vein punctures.
The National Institute for Health and Care Excellence (NICE), the medicines cost-effectiveness body for England and Wales, has recommended a new treatment to help patients suffering from blood clots in the legs and lungs.
The first patient has been enrolled in ETNA-AF-Europe (Edoxaban treatment in routine clinical practice – atrial fibrillation – Europe), and ETNA-VTE-Europe (Edoxaban treatment in routine clinical practice – venous thromboembolism – Europe) has commenced.
Results of the landmark CATCH (Comparison of Acute Treatments in Cancer Haemostasis) study were published in The Journal of American Medical Association (JAMA), comparing innohep (tinzaparin), a low-molecular weight heparin (LMWH), with warfarin in patients with cancer-associated thrombosis.
Kimihiko Kichikawa, Department of Radiology at Nara Medical University in Japan, reported two-year results of the Zilver PTX post-market surveillance (PMS) study on 27 September 2015, in Lisbon, Portugal. Kichikawa presented initial target data on lesion revascularisation at Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2015.
Stentys, a medical technology company commercialising the Self-Apposing coronary stent, announced on 28 September 2015 that the company’s drug-eluting stent received the CE mark for treatment of below-the-knee (BTK) arteries, making Stentys’ product the first self-expanding and drug-eluting stent with regulatory approval in Europe for this indication.
On the back of these results, Stephan Müller-Hülsbeck announced the commencement of an international multicentre randomised controlled trial that will compare the Eluvia drug-eluting vascular stent system (Boston Scientific) with Zilver PTX, the drug-eluting stent system from Cook Medical. The principal investigators will be Müller-Hülsbeck (Flensburg, Germany) and William Gray (New York, USA).
BTG announced promising data on Sunday, 27 September, for DC BeadM1, supporting the efficacy and tolerability of doxorubicin-eluting DC BeadM1in the treatment of patients diagnosed with liver-confined hepatocellular carcinoma (HCC). The preliminary results of the single-centre, retrospective, single-arm study, in which patients achieved a median overall survival of 41 months, were presented during the 2015 CIRSE (Cardiovascular and Interventional Radiological Society of Europe) conference in Lisbon, Portugal. While DC Bead drug-eluting bead is backed by clinical safety and efficacy data in over 3,000 HCC patients, DC BeadM1 is a more recent addition to the product range. Designed with a narrow size distribution, so that it can travel deeper into the vasculature of the tumour, while also allowing for a more concentrated drug delivery, DC BeadM1 offers a new standard-of-care and a much more targeted therapy than conventional chemoembolisation for the treatment of HCC.
The 2015 annual meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in September in Lisbon, Portugal, marks a special occasion—it will be 30 years since a key meeting in Austria in 1985, in which a merger of two societies led to the birth of CIRSE. Interventional radiology on the continent has come a long way in these years following its modest, but promising, beginnings.
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