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.
Boston Scientific Corp. (NYSE:BSX) will abandon its flagship headquarters in Natick, Mass., along Route 9, moving its headquarters to Marlborough, where the medical device giant already has operations.
Boston Scientific Corporation (NYSE: BSX) is extending its reach into the strategically critical renal denervation market by signing a definitive agreement to acquire Vessix Vascular, Inc., a privately held company based in Laguna Hills, California. Vessix Vascular has developed a catheter-based renal denervation system for the treatment of uncontrolled hypertension. The acquisition is expected to close by the end of November 2012.
October 26, 2012—Terumo Interventional Systems (Somerset, NJ) announced the nationwide availability of its new Pinnacle Precision Access System, which is designed for smooth, efficient, and reliable vascular access. The Pinnacle Precision Access System features a tapered introducer needle to minimize vessel trauma, dilate the tissue, and gain more precise access in difficult cases, such as those impeded by scar tissue or calcification. The device eliminates the need for both a micropuncture kit and a standard size introducer sheath.
Survival of patients treated with SIR-Spheres more than double that of patients who received best supportive care, benefit rivals that found with new biological agents, authors note.
Kona Medical has announced the initiation of the first clinical study of its device therapy for drug-resistant hypertension. The Kona Surround Sound system utilises focused ultrasound, delivered from outside the body, to treat the nerves leading to and from the kidney.
Medtronic announced on 22 October new results from Symplicity HTN-1, the longest running clinical trial investigating the safety and efficacy of renal denervation. These data showed patients who received renal denervation treatment with the Symplicity system experienced a mean blood pressure reduction of -29/-14mm Hg (p<0.01) at 24 months (n=105).
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