IRVINE, Calif.--(BUSINESS WIRE)--Blockade Medical LLC, a privately held company focused on the development of catheter based therapeutic devices for the treatment of cerebral aneurysms, announced today that more than 100 patients have been successfully treated with the Barricade Coil SystemTM. The patients treated, presented with a wide range of cerebral aneurysms and peripheral lesions. All treated patients had positive clinical outcomes without any reported complications.
DAYTON, Ohio--(Healthcare Sales & Marketing Network)--ClearRead +Confirm, new software from Riverain Technologies that improves the clarity of conventional chest X-ray images and allows radiologists to rapidly confirm the proper placement of tubes, lines and wires, has received 510(k) clearance from the Food and Drug Administration (FDA).
Los chequeos de rutina no ayudan a reducir el riesgo de un paciente de morir de enfermedad cardiaca ni de cáncer, sugiere una investigación danesa reciente.
Results from the Symplicity HTN-2, the first randomised clinical trial investigating renal denervation, were published online before print in Circulation, the Journal of the American Heart Association. These data showed patients, who initially received treatment with the Symplicity renal denervation system (n=47), sustained a significant drop in blood pressure (-28/-10 mm Hg [p<0.001]) compared to baseline at 12 months. The 12 month results demonstrated preservation of the benefit at six month follow-up (-32/-12 mm Hg). No device related serious adverse events, no late vascular complications, and no significant decline in kidney function were reported at 12 months.
The initial version of the single, high-power, high-frequency 2.45GHz saline-cooled needle was cleared for use in the USA as part of the Acculis MTA system in 2010. Following two years of global distribution, and in response to customer feedback and growing product demand, Microsulis has updated the device’s design and manufacturing process. Improvements include a refined optically clear moulded handle and improved connection cartridge.
Boston Scientific has announced that the first patient has been enrolled in a study comparing its WallFlex Biliary RX Fully Covered self-expanding metal stent (SEMS) to plastic stents for the treatment of benign bile duct strictures caused by chronic pancreatitis.
España, diciembre de 2012.- VWNG® (Venous Window Needle Guide, o Guía de punción de acceso venoso) es una nueva guía para agujas de diálisis que facilita la canulación y previene muchos de los problemas asociados a este proceso. Está fabricada en titanio y se implanta debajo de la piel, directamente sobre la fístula arteriovenosa. Es de gran utilidad para conseguir una canulación precisa.
On 3 December, Volcano Corporation announced it has signed an agreement to acquire Crux Biomedical, developer of the Crux VCF System―an inferior vena cava (IVC) filter designed to prevent pulmonary embolisms.
The National Institute for Health and Clinical Excellence (NICE) clinical guidelines for uterine artery embolization state that more treatment options are required for women with uterine fibroids. The FEMME trial (A randomised trial of treating fibroids with either embolization or myomectomy to measure the effect on quality of life, among women wishing to avoid hysterectomy) sponsored a booth at the British Society of Interventional Radiology’s (BSIR) Annual Meeting (14–16 November, Bournemouth, UK) and is currently recruiting patients in order to examine the effectiveness of uterine artery embolization in comparison to myomectomy in the treatment of symptomatic fibroids.
The US Food and Drug Administration (FDA) has given clearance to Thermedical to market its innovative technology for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.
Vascular Closure Systems has announced the successful conclusion of phases I and II of the first-in-human clinical trial for its 6F and 7F FastSeal Bioabsorbable Vascular Access Closure System. Data have shown exceptional time to haemostasis (TTH) and time to ambulation (TTA) in both phases of the clinical trial.
GE Healthcare announced at the Radiological Society of North America (RSNA, Chicago, USA, 25–30 November) 98th annual meeting the FDA clearance for its advanced imaging tool, FlightPlan for Liver. According to the company, this tool is being developed to help make intricate liver embolization procedures simpler.
By Christopher L Brace. Thermal ablation has become a key player in the treatment of not only liver cancer, but tumours in the kidney, lung and bone as well. Radiofrequency and cryoablation devices were first to market and remain the most widely used tools today. Ablation can provide overall survival rates similar to surgical resection for small hepatic tumour but in spite of this, it has also been associated with higher local recurrence rates. Why? The lack of an appropriate ablative margin (5–10mm) is the greatest predictor of local recurrence. Radiofrequency and cryoablations are typically 20–30mm in diameter, which can theoretically treat a 10–20mm tumour and a margin. However, the average tumour treated with ablation is around 25mm, just at the edge of what is practical. Proximity to a large blood vessel, which can protect adjacent tumour cells from thermal damage, has also been implicated in recurrence.
Angiotech Pharmaceuticals, Inc. ("Angiotech") announced that its partner Cook Medical, Inc. ("Cook") received approval on November 15, 2012 from the U.S. Food and Drug Administration ("FDA") to market and sell the proprietary Zilver® PTX® drug-eluting peripheral stent, adding the United States to the list of over 50 markets, including the European Union and Japan, where Zilver PTX is approved for sale. Zilver PTX is the first drug-eluting stent indicated for use in peripheral artery disease approved by the FDA.
Teleflex Incorporated (TFX), a leading global provider of medical devices for critical care and surgery, has announced that its Semprus BioSciences subsidiary has been granted 510(k) clearance for the Company’s innovative vascular access catheter, the Nylus™ Peripherally Inserted Central Catheter (PICC) with Semprus Sustain™ Technology. The Nylus PICC is indicated to provide peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, central venous pressure monitoring and power injection of contrast media. The FDA clearance follows the product’s European market clearance in July, 2012.
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