BTG and Mirada Medical announced CE mark certification for the Simplicit90Y dosimetry software, designed to optimise the planning of Y-90 selective internal radiation therapy and facilitate personalised treatment for patients with liver cancer. CE mark certification follows approval for Simplicit90Y in Canada.
New European Society of Medical Oncology (ESMO) biliary cancer guidelines indicate yttrium-90 (Y-90) therapy as an option for post-chemotherapy treatment of intrahepatic cholangiocarcinoma.
The SOLSTICE clinical study constitutes the largest multicentre, prospective study focused on the clinical use and effectiveness of cryotherapies for patients with primary cancer lesions that have metastasised to the lung. The study was launched in 2014 by Galil Medical, which is now a part of BTG.
NEAT (Novel endovascular access trial) data presented at the Vascular Interventional Advances (VIVA) 2016 meeting (18–22 September, Las Vegas, USA) suggest that endovascular arteriovenous fistula creation using everlinQ technology (TVA Medical) is associated with almost six-fold fewer post-creation interventions and may be approximately US$11,000 cheaper than surgical fistula creation.
Timothy P Murphy, Vascular Disease Research Center, Rhode Island Hospital, Providence, USA, and one of the investigators on the CORAL study, told delegates at CIRSE 2016 in Barcelona, Spain, that a low urine albumin:creatinine ratio could be used to help identify a large group of patients with renal artery stenosis who might benefit from stenting.
InspireMD has announced 12-month follow up data from PARADIGM-101 study of the CGuard Embolic Prevention System (EPS), which were presented at the Transcatheter Cardiovascular Therapeutics symposium (TCT 2016, 29 October–2 November, Washington, DC, USA).
Shockwave Medical has announced plans for DISRUPT PAD III—what it claims is the “largest ever” multicentre randomised study to exclusively enrol patients with calcified peripheral artery disease.
The US Food and Drug Administration (FDA) has granted staged approval for Intact Vascular’s investigational device exemption (IDE) application to begin its TOBA II BTK (Tack optimised balloon angioplasty II below the knee) clinical study. The study will examine the safety and efficacy of the Tack endovascular system when used to repair dissections in the arteries below the knee following percutaneous transluminal angioplasty as a treatment for critical limb ischaemia.
St Jude Medical has announced that, based on the preliminary voting results from St Jude Medical’s Annual Meeting of Shareholders held on 26 October, St Jude Medical shareholders approved the merger agreement under which Abbott will acquire St Jude Medical.
Medtronic has received US FDA 510(k) clearance for the HawkOne directional atherectomy system in a new size for treating patients with peripheral artery disease. The HawkOne system is designed to remove plaque from the vessel wall and restore blood flow. The new HawkOne 6F provides an effective and easy-to-use treatment option for patients with peripheral artery disease both above and below the knee with a single device at a lower profile.
Most people have heard about personalised medicine. How about personalised medical devices? Northwestern’s McCormick School of Engineering researchers Guillermo Ameer and Cheng Sun have teamed up to use 3D printing to develop flexible, biodegradable stents that are customisable to suit a specific patient’s anatomy.
Abbott and St Jude Medical have announced an agreement in principle to sell certain products to Terumo Corporation.The agreement is an important step toward completion of Abbott’s acquisition of St Jude Medical. Abbott’s acquisition of St Jude Medical is expected to close by year-end.
Shockwave Medical has announced positive clinical results from the pooled DISRUPT PAD study, a single-arm, two-phase, multicentre study evaluating the safety and performance of the company’s Lithoplasty system in calcified peripheral lesions. The data were presented at Vascular Intervention Advances (VIVA) 2016 meeting (18–22 September, Las Vegas, USA). “The ongoing positive results from DISRUPT PAD demonstrate that Lithoplasty technology is a promising treatment for patients with calcified peripheral artery disease, a difficult-to-treat population”
Ten-year outcomes from the randomised controlled EMMY trial were presented at CIRSE 2016 (10–14 September, Barcelona, Spain) by Jim Reekers, Academic Medical Center, Amsterdam, The Netherlands. The results have also been published in July 2016 in the American Journal of Obstetrics and Gynecology by de Bruijn AM and colleagues.
Teleflex has announced that it has received US FDA 510(k) clearance to market its Arrow JACC with Chlorag+ard technology and TightTrack tunneler.
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