BTG has announced the successful outcome of the RENEW study, the pivotal US randomised controlled clinical trial comparing the safety and efficacy of the PneumRx endobronchial coil implant with a medical therapy control group in patients with homogeneous and/or heterogeneous severe emphysema. All primary and secondary endpoints of the study were met.
ArtVentive Medical has conducted the first animal study of its next generation of the ArtVentive Endoluminal Occlusion System (EOS Gen II). The EOS is designed for use in the peripheral vasculature and offers immediate and permanent vessel occlusion in arterial and venous settings.
Stentys has announced that the first interventions using its self-expanding drug-eluting stent to treat BTK (below-the-knee) arterial disease have been performed during two live-case sessions broadcasted during the Leipzig Interventional Course (LINC).
Performing angioplasty with new drug-coated balloons to treat femoropopliteal artery disease results in lower rates of late lumen loss and clinically-driven target lesion revascularisation compared with plain angioplasty at both six- and 12-month follow-up, according to new data.
Essential Medical has completed enrolment of its European CE mark clinical study of Manta, the company’s large bore vascular closure device.
Patient enrolment has begun in Bad Krozingen, Germany, for Mercator MedSystem’s LIMBO-PTA clinical trial. This study measures the benefits of adding drug delivery to the catheter-based re-opening of the arteries below the knee in patients suffering from critical limb ischaemia (CLI). The trial combines localised drug delivery using the Mercator MedSystem Bullfrog micro-infusion device and dexamethasone with angioplasty.
In a presentation at the 2015 Vascular Interventional Advances meeting (VIVA; 2–5 November, Las Vegas, USA), Krishna Rocha-Singh, St John’s Hospital, Springfield, USA, gave an insight into the VIVA Superficial Femoral Artery Nitinol Stent Patient Level Meta-analysis, suggesting that patients with higher ankle-brachial index and shorter lesions have the most positive outcomes. He emphasised the importance of “robust and independently adjudicated” data and more standardised endpoints.
Vivasure Medical has been granted CE mark approval for its fully bioabsorbable percutaneous vascular closure device for large-bore femoral arteriotomies. According to Vivasure, this is the world’s first approved bioabsorbable, sutureless and fully synthetic option to close large arteriotomies, which result from percutaneous transcatheter procedures.
NuCryo Vascular has received 510(k) clearance for its reusable cryoplasty inflation device. NuCryo will be selling the current and next generation model via a direct sales team.
Patients with high baseline diastolic blood pressure undergoing carotid endarterectomy are at increased risk of stroke, myocardial infarction, or death within 30 days of the procedure, according to results from the International Carotid Stenting Study (ICSS). In a paper published in the European Journal of Vascular and Endovascular Surgery, the authors say that in the context of a single preoperative measurement of blood pressure, diastolic blood pressure might be a better predictor than systolic blood pressure.
Data from the PYTHAGORAS (Prospective aneurysm trial: high angle Aorfix bifurcated stent graft) clinical trial suggest that the Aorfix (Lombard Medical) endograft remains the only on-label alternative to open abdominal aortic aneurysm repair for patients with highly angulated aortic necks, according to Mark Fillinger, Dartmouth Hitchcock Medical Center, Lebanon, USA, who presented the data at the 2015 VEITHsymposium (17–21 November, New York, USA).
The Supera peripheral stent offers the lowest risk of repeat procedures and is an “economically attractive” treatment for both payer and provider, according to a cost-effectiveness analysis presented at the 2015 VIVA meeting (2–5 November, Las Vegas, USA). The data were presented by Brian DeRubertis, University of California Los Angeles, USA.
Laminate Medical Technologies has announced the success of the first two German clinical cases using VasQ—an external support device for arteriovenous fistulas implanted during the fistula creation surgical procedure—following CE approval and 24 clinical cases completed at St George’s Hospital, London, UK.
The European Diagnostics Manufacturers Association (EDMA) and the European Medical Technology Industry (Eucomed) have approved a new joint code of conduct that stipulates that, after 31 December 2017, industry should no longer provide direct “financial or in kind support” to individual healthcare professionals to cover the costs of them attending third-party medical conferences. However, the new code does say that industry can provide educational grants to healthcare organisations to enable them to pay for physicians to attend conferences.
An interventional radiology technique shows promise for helping morbidly obese patients lose weight, according to the preliminary results of a study presented on 1 December 2015 at the annual meeting of the Radiological Society of North America (RSNA).
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