BrightWater Medical has announced that the US FDA has cleared the company’s innovative ConvertX nephroureteral stent system for treatment of ureteral obstructions.
“There is no easy fix with current endovascular tools and strategies and a default realisation is that it is easier and more definitive to treat aortic dissection early,” Michael D Dake, Stanford, USA, told Interventional News about the Achilles heel of thoracic endovascular aneurysm repair (TEVAR) management for uncomplicated type B dissection.
Selective internal radiation therapy (SIRT) has been available since December 2013 to a defined group of patients with liver metastases in England on the National Health Service (NHS) via a special Commissioning through Evaluation scheme from NHS England. However, NHS England has now decided to stop funding SIRT at the end of March 2017 while it analyses the data obtained so far.
Spectranetics has announced that its Stellarex 0.014” drug-coated angioplasty balloon has received the CE mark. The device is designed to treat small vessels, below-the knee disease, and challenging critical limb ischemia in patients.
Cook Medical has completed enrolment in the first clinical study of an iliofemoral venous stent conducted in the USA under a US FDA-approved investigational device exemption.
Ulipristal acetate is the first oral therapy to demonstrate efficacy and safety for uterine fibroids in two US pivotal studies, a press release states.
The European Society of Radiology (ESR) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), have joined forces to address the future of diagnostic and interventional radiology with a special focus on improving patient care.
Robert Califf is to step down as US Food and Drug Administration (FDA) commissioner upon the inauguration of Donald Trump as US President on 20 January 2017. Democrat Califf, who was appointed to the post in September 2016 by Barack Obama, is required to resign along with other presidential appointees.
A study, published in the Journal of Vascular and Interventional Radiology suggests that percutaneous image-guided irreversible electroporation of unresectable locally advanced pancreatic adenocarcinoma is associated with a satisfactory safety profile.
Teleflex has announced that its Arrow VPS Rhythm device with optional TipTracker technology has been issued 510(k) clearance so that the device can be commercialised in the USA.
Abbott announced on 4 January 2017 that it has completed the acquisition of St Jude Medical.
NICE’s Scientific Advice programme will work with companies looking to attain both FDA approval and payer coverage. The UK’s National Institute for Health and Care Excellence (NICE) has announced its participation in the US Food and Drug Administration (FDA)’s Payer Communication Taskforce. This programme aims to accelerate US patient access to new technologies by gathering evidence of clinical effectiveness in an attempt to encourage US insurers to fund new treatments, post FDA-approval.
BTG International Canada has announced the commercial launch of DC Bead Lumi in Canada. The launch represents the first market commercialisation of DC Bead Lumi in the world, with regulatory clearances and launches planned for additional markets worldwide.
Sirtex has announced that SIR-Spheres Y-90 resin microspheres have been included as a Category 2A recommended treatment in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for colon cancer and rectal cancer. This designation denotes that there is uniform consensus among the NCCN panel that selective internal radiation therapy (SIRT) with yttrium-90 microspheres is an appropriate option in patients with liver dominant, chemotherapy resistant colorectal disease. This recommendation places SIR-Spheres Y-90 resin microspheres at the same designation as the recommended mCRC systemic chemotherapeutic regimens.
WCIO has announced via email communication that the board of directors of the organisation, a non-profit association that supports and promotes the field of interventional oncology (IO), has established the Society of Interventional Oncology (SIO), effective 17 January. The society’s annual IO conference will maintain its name of WCIO.
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