The US Food and Drug Administration (FDA) has released a draft guidance document entitled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”.
Speaking at the World Conference on Interventional Oncology (WCIO; 9–12 June, Boston, USA), George Carberry (University of Wisconsin School of Medicine and Public Health, Madison, WI, USA) reported that positioning an antenna at least 5mm away from the heart when performing microwave ablation of the lung is associated with a significant reduction in arrhythmia and cardiac tissue injury compared with positioning the antenna nearer to the heart.
AV Medical has announced the commencement of cases in the US with its Chameleon percutaneous transluminal angioplasty balloon catheter.
The results from a prospective, randomised study, published online ahead of print in the Journal of Vascular and Interventional Radiology (JVIR) suggest that stent graft use provides a sustained, greater than two-fold advantage over angioplasty in treatment area and overall access patency in arteriovenous access graft stenosis.
New data presented by Volker Heinemann in an oral abstract session at the European Society of Medical Oncology’s 18th World Congress on Gastrointestinal Cancer suggest that patients with liver-dominant mCRC treated first-line with the combination of mFOLFOX6 and SIR-Spheres Y-90 resin microspheres in the recently published SIRFLOX study experienced a much more profound response to treatment in the liver than those who received chemotherapy alone.
SRS Medical Systems has announced that it has received CE mark approval for use of its Spanner temporary prostate stent in the European Economic Area (EEA). Spanner is an alternative to both indwelling (Foley) and intermittent urinary catheters for male patients with bladder outlet obstruction.
The Society of Interventional Radiology (SIR) has submitted comments to the Centers for Medicare and Medicaid Services (CMS) recommending changes to its April 27 2016 Quality Payment Program proposed rule.
Ask4UFE.com, a website created to educate women about fibroid treatment options including uterine fibroid embolization, recently relaunched making it easier for patients to find a physician in their area.
For older patients with small (T1a) renal cancer, percutaneous ablation is associated with much lower costs than partial or radical nephrectomy, both at the time of treatment and through the first year after treatment, new research has shown.
Bluegrass Vascular has announced receiving CE mark approval for the Surfacer Inside-Out access catheter system, indicated for obtaining central venous access to facilitate catheter insertion into the central venous system via a novel “Inside-Out” approach. The company is also launching a limited commercial sale of the system.
A new study, based on patient-reported outcomes, published online ahead of print on 17 August in JAMA Surgery reports that patients with intermittent claudication who received a revascularisation intervention (either endovascular or surgical) had significantly improved function, better health-related quality of life and fewer symptoms at 12 months compared with those who received medical management.
On 17 August, a multicentre, randomised, double-blind, placebo-controlled trial—the VAPOUR trial—was published online ahead of print in The Lancet. Six-month data from the trial provide the first sham-controlled evidence in support of using the procedure.
Insightec has announced that Exablate, which uses magnetic resonance-guided focused ultrasound (MRgFUS), for pain palliation of bone metastases in cancer patients is now a covered benefit for members of a major health insurance provider in the USA. The procedure is non-invasive and uses no radiation to control painful metastases.
The US Food and Drug Administration has announced that Dutch company DSM Biomedical BV—Cook Medical’s supplier of hydrophilic coating for the Roadrunner Uniglide hydrophilic wire guide, has recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4–280µm.
The first use of Endologix’s Ovation Alto abdominal stent graft system has been reported in two patients with abdominal aortic aneurysms (AAA). The patients were treated by Andrew Holden and Andrew Hill of Auckland City Hospital, Auckland, New Zealand.
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