Janssen has submitted a supplemental new drug application to the US Food and Drug Administration (FDA) for two new Xarelto (rivaroxaban) vascular indications: reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke in patients with chronic coronary and/or peripheral artery disease (CAD/PAD), and for reducing the risk of acute limb ischaemia in patients with PAD.
Merit Medical has announced signing an asset purchase agreement with BD (Becton, Dickinson and company) to acquire certain assets which BD proposes to sell in connection with its proposed acquisition of CR Bard. Merit’s proposed asset acquisition is subject to the closing of BD’s proposed acquisition of Bard as well as other usual and customary closing conditions.
Terumo has announced that it has launched QuiremSpheres microspheres in Europe on 18 September.
TVA Medical’s everlinQ 4 endovascular arteriovenous fistula (AVF) system has received CE mark in the European Union. The technology uses a 4F catheter system with enhanced visual indicators to create haemodialysis access using an endovascular technique without open surgery.
The US Food and Drug Administration has cleared Adhezion Biomedical’s SecurePortIV catheter securement adhesive for marketing.
BTG has highlighted the results of the ACCESS PTS trial, presented at the Society for Vascular Medicine 28th annual scientific sessions (14–17 June, New Orleans USA). The study found chronic deep vein thrombosis patients with post-thrombotic syndrome can be treated safely and effectively with Ekos therapy.
Adept Medical, the Auckland based manufacturer of the STARSystem, has announced the release of its latest product innovation, the I.R. Platform (interventional radiology platform). The I.R. Platform is an over-the-patient work surface, specifically designed for use by interventional radiologists when they are working through the femoral artery.
Argon Medical announced in June that it has formalised a Medical Advisory Board comprised of distinguished physicians from institutions across the USA who specialise in interventional medicine. The Medical Advisory Board will continue to provide scientific and clinical expertise to guide the organisation in planning and implementing product development initiatives and marketing programs with the goal of improving the lives of patients and their caregivers, a press release from the company states.
The ASTER randomised clinical trial that examined the effect of endovascular contact aspiration vs. stent retriever on revascularisation in patients with acute ischaemic stroke and large vessel occlusion in the anterior circulation found that first-line thrombectomy with contact aspiration compared with stent retriever did not result in an increased successful revascularisation rate at the end of the procedure.
Augmenix, a medical technology company that develops, manufactures, and sells proprietary absorbable hydrogels that separate and protect organs at risk during radiotherapy and interventional procedures, announced that the first patients have been treated with SpaceOAR hydrogel at the Chaim Sheba Medical Center in Tel Hashomer, Israel. SpaceOAR hydrogel is an absorbable prostate-rectum spacer that reduces rectal injury during prostate radiotherapy.
Avinger has announced positive two-year clinical data from the pivotal VISION study of the company’s Lumivascular technology. Twenty-four-month follow-up results from 89 patients were presented by Patrick Muck, chief of Vascular Surgery at Good Samaritan Hospital in Cincinnati, USA, at New Cardiovascular Horizons (NCVH) in New Orleans, USA. This includes an additional 34 patients beyond the interim data set presented on January 25, 2017.
Bard’s Lutonix 035 drug-coated balloon PTA catheter (DCB) has been granted premarket approval (PMA) by the US Food and Drug Administration (FDA) for a new indication and is now available for sale in the USA.
Biotronik has announced that 12-month data from the BIOFLEX-I study have demonstrated the safety and efficacy of the company’s Pulsar-18 self-expanding stent for blocked superficial femoral artery treatment.
BTG and the Society of Interventional Oncology (SIO) have expanded their commitment to the Immuno-oncology /interventional oncology research grant programme, by announcing a second round of funding available to investigators.
“As interventional radiology is established as a free standing specialty, an international outreach effort to establish guidelines for different interventional treatments is certainly needed,” Constantinos T Sofocleous, Memorial Sloan Kettering Cancer Center, New York, USA, and professor of Radiology, Weill Medical College of Cornell University, New York, tells Interventional News. Sofocleous is chair of the Scientific Programme Committee of World Conference on Interventional Oncology (WCIO) 2016.
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