Five-year data from the INSPIRATION US investigational device exception (IDE) pivotal trial confirms favourable safety and effectiveness of the INCRAFT device. Presenting the trial at the Society of Vascular Surgery (SVS) Vascular Annual Meeting (VAM; 12–15 June, National Harbor, USA), Michel Makaroun, University of Pittsburgh (Pennsylvania, USA) surmised that the INCRAFT device “offers unique benefits in patients with challenging access anatomy”, while it “may provide a useful option for patients with infrarenal abdominal aortic aneurysms”.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Centerline Biomedical’s Intra-Operative Positioning System (IOPS), a device used in endovascular procedures to provide 3D visualisation.
A new visualisation method enables more precise catheter navigation through the vascular system. It is being developed at the Fraunhofer Institute for Digital Medicine (MEVIS) in Bremen, Germany, and one of its ambitions is to reduce physician radiation exposure.
Siemens Healthineers and Mentice AB have announced that they are collaborating to fully integrate Mentice’s VIST virtual patient into the Artis icono angiography system from Siemens Healthineers.
Micro Medical Solutions has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA). IDE approval allows the company to initiate a US pivotal clinical trial to evaluate MicroStent’s safety and efficacy. A press release reports that MicroStentis a vascular stent specifically designed to achieve and maintain vessel patency and improve blood flow in order to reduce below-the-knee amputations for patients with critical limb ischaemia resulting from peripheral arterial disease.
The OVER trial investigators, led by the late Frank Lederle, recently released the long-term results of endovascular aneurysm repair (EVAR) versus open repair. Janet Powell writes for Vascular News about the 14-year outcomes, which were published in the New England Journal of Medicine, how they compare to other similar randomised controlled trials’ results, and what the data contribute to the ongoing conversation about the durability of EVAR.
According to a recent study, an endovascular approach is “safe and effective” in the treatment of abdominal aortic aneurysms detected by the National Abdominal Aortic Aneurysm Screening Programme (NAAASP). Furthermore, the investigators found no aneurysm-related mortality in those treated electively for infrarenal aneurysms, and the overall reintervention rate was “relatively low”.
The Cardioform ASD Occluder (Gore Medical) has received US Food and Drug Administration (FDA) premarket approval (PMA) for use in the percutaneous closure of ostium secundum atrial septal defects (ASDs). A press release from the company says that the FDA approval was supported by data collected from the pivotal stage of the Gore ASSURED clinical study which demonstrated 100% closure success at six-months in patients with a successful implant.
A new Expert Panel Report, published in The Diabetic Foot Journal, recommends a new treatment algorithm for topical oxygen therapy in patients with diabetic foot ulcers (DFU). The new treatment algorithm recommends that topical oxygen therapy is considered as an adjunct to standard of care after four weeks if the wound area has not reduced by 40%. In addition, it recommends that early initiation (<4 weeks) of topical oxygen therapy could be beneficial for patients where peripheral arterial disease (PAD) is present, where there is ulcer pain, non-healing after amputation, or sloughy wounds.
Vikram S Kashyap, co-principal investigator of the ROADSTER 2 trial, today presented the final 30-day outcomes of the post-market approval study in a late-breaking trial session at the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM; 12–15 June, National Harbor, USA). The data show the sustained safety and efficacy of transcarotid artery revascularisation (TCAR) with Silk Road Medical’s Enroute system. In this interview, Kashyap speaks to Vascular News about the procedure, and how TCAR trialists are hoping to make an impact for patients needing carotid revascularisation.
The halted BASIL-3 study now plans to resume enrolment of patients into the randomised controlled trial, which is comparing balloon angioplasty versus stenting for severe ischaemia in the legs of patients with peripheral arterial disease (PAD). Two of the three trial arms use paclitaxel-coated or -eluting devices.
The Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI), with its large multicentre registries has produced several datasets for analysis of vascular patient care in the USA. This year, at the SVS Vascular Annual Meeting (VAM; 12–15 June, National Harbor, USA), new data produced with the use of the VQI was presented by Daniel Bertges (University of Vermont Medical Center, Burlington, USA) aimed to provide further insight into mortality following peripheral vascular interventions using paclitaxel devices. This study “highlights the potential use of the VQI for surveillance of the safety of new peripheral arterial devices”, the investigators state in their abstract.
Significant annual cost savings found with UrgoStart in UK and Germany
Thrombolex announces 510(k) clearance of Bashir catheter systems for thromboembolic disorders
SAVE-US pivotal trial completes enrollment and has positive clinical results
Endologix announces reinstatement of CE mark for its Nellix endovascular aneurysm sealing system
Who should have a Cardiac CT?
Phone: (028) 3981 2678
Mobile: 0903 839 878 - 0909 384 389