A surgical-first strategy appears to be superior to endovascular treatment for critical limb ischaemia revascularisation, exhibiting improved wound healing rate and overall healing time, according to data presented by Jin Okazaki (Kitakyushu, Japan) at the Vascular Annual Meeting (VAM; 30 May–3 June, San Diego, USA).
Surmodics has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a pivotal clinical trial of the SurVeil drug-coated balloon (DCB). The randomised trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in the upper leg compared to the IN.PACT Admiral DCB (Medtronic).
A large study of the outcomes of 3,033 patients undergoing lower extremity bypass has reported a 10.6% infection rate and identified procedural risk factors. As reported in the June edition of the Journal of Vascular Surgery, vascular surgeon Peter Henke and researchers from the University of Michigan, Ann Arbor, USA, used data from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium Vascular Intervention Collaborative (BMC2 VIC) to carry out the study.
TVA Medical has announced the online publication of positive results from the Novel Endovascular Access Trial (NEAT) evaluating its everlinQ endoAVF system. The 12-month data published online in the American Journal of Kidney Diseases (AJKD), the official journal of the National Kidney Foundation, demonstrate the potential benefit of the novel approach to create haemodialysis access as an alternative to traditional open surgery.
The UK’s Information Commissioner’s Office (ICO) has found that the Royal Free National Health Service (NHS) Foundation Trust (London, UK) did not adhere to the UK’s Data Protection Act when it provided patient details to Google DeepMind.
Public Health England (PHE) and the Royal Society for Public Health (RSPH) have published “Everyday Interactions”, a report which aims to support healthcare professionals to record and measure their public health impact.
The US Food and Drug Administration (FDA) has cleared Stroke2prevent’s A-view device for commercialisation on the US market. The A-view is a balloon catheter designed for visualisation of the aortic arch by transoesophageal echocardiography (TEE).
Teleflex’ Arrow Seldinger arterial catheterisation device received market clearance from the US Food and Drug Administration (FDA).
Data from the PATENCY-1 trial indicate that the application of vonapanitase (Proteon Therapeutics) at the time of fistula surgery is associated with increased fistula survival and use for haemodialysis.
To prevent surgical site infections (SSI) during abdominal aortic aneurysm repair surgery, a mainstay, widely-spread approach is to dip stent grafts in rifampicin before implantation. However, new research indicates that this approach could contribute to the global emergence of multi-drug resistant bacteria.
The results of the ACCESS PTS trial have been presented at the Society for Vascular Medicine 28th Annual Scientific Sessions (14–17 June, New Orleans, USA). The study found chronic deep vein thrombosis (DVT) patients with post-thrombotic syndrome (PTS) can be treated safely and effectively with EKOS therapy. The ACCESS PTS protocol using EKOS therapy is now the only treatment regimen proven to significantly reduce the signs and symptoms of PTS and show a significant improvement in quality of life.
Endovenous adhesive closure systems are a useful adjunct to thermal ablation treatment for varicose veins, but it is vital that the possible side-effects of such treatments are discussed openly with patients pre-procedurally, according to a presentation at the European Venous Forum (EVF; 29 June–1 July, Porto, Portugal).
Bio2 Medical has announced the results of the Angel Catheter pivotal study published in the Journal of Vascular and Interventional Radiology. The Angel Catheter met all safety endpoints and demonstrated a significant reduction in clinically significant and fatal pulmonary embolism (PE).
The US Food and Drug Administration (FDA) has accepted, for priority review, a supplemental new drug application (sNDA) for Janssen’s Xarelto (rivaroxaban), to include a 10mg once-daily dose for reducing the risk of venous thromboembolism (VTE) after at least six months of standard anticoagulant therapy.
Bluegrass Vascular Technologies has enrolled over one third of its patients in the company’s post-market SAVE (Surfacer System to Facilitate Access in Venous Occlusions) clinical study. The SAVE study is an international, prospective, multicentre clinical follow-up study designed to confirm clinical performance and safety of the Surfacer inside-out access catheter system, a device indicated for obtaining central venous access to facilitate catheter insertion into the central venous system in patients with chronically occluded veins.
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