Results from the EnligHTN I trial have shown that the EnligHTN renal denervation system (St Jude Medical) is safe and effective for the treatment of resistant hypertension. Data released during the ESC Congress 2012 demonstrated that on average patients with resistant hypertension experienced a rapid systolic blood pressure reduction of 28 mmHg points after 30 days that remained stable with a reduction of 27 mmHg points three months after treatment.
Medtronic announced new results from SYMPLICITY HTN-2, the only randomised clinical trial investigating safety and efficacy of renal denervation. The 18-month data presented for the first time at the European Society of Cardiology (ESC) Congress on 26 August 2012 showed that the Symplicity system continues to provide superior and sustained blood pressure reduction in patients with treatment-resistant hypertension. The safety of renal denervation with the Symplicity system was also maintained at 18 months, with no device-related serious adverse events and no newly reported vascular complications from 12–18 months.
Toshiba America Medical Systems has received FDA clearance for its Aquilion RXL Edition CT system. The Aquilion RXL reconstructs images faster and includes the latest dose reduction technologies, providing faster, safer information to physicians and patients.
The System, a collaborative film by the British Society of Interventional Radiology (BSIR) and the Health Foundation, an independent charity, traces the way in which a combination of factors are shown to converge during a biliary intervention procedure carried out on a patient.
At the GEST 2012 US meeting in New York, USA, James B Spies, Georgetown University Hospital, Washington DC, USA, outlined the basic properties of spherical particles.
David N Siegel, chief, Division of Vascular and Interventional Radiology, Northshore Island Jewish Health System, New York, USA, told delegates at GEST 2012 US that interventional radiologists must take primary responsibility for the initial evaluation and management of post-uterine fibroid embolization patients.
Delcath Systems has announced that it has submitted a new drug application to the FDA seeking approval for the company’s proprietary chemosaturation system for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver. The company included its Generation 2 filter in its submission as a technical change to the chemistry, manufacturing, and control (CMC) module.
On 14 August, Sound Interventions released three-month data from the company’s first-in-human clinical study (SOUND-ITV) to treat resistant hypertension through the use of catheter-based ultrasound.
Vascular Solutions has launched the SuperCross FT, a new flexible-tip version of its line of SuperCross microcatheters. SuperCross FT has been designed to address the majority of complex interventional procedures in which a flexible tipped microcatheter is needed.
Miyuki Sone, from the National Cancer Center, Japan made the case for gelfoam remaining an essential embolic material in the future at GEST 2012 US (May, New York, USA).
Olympus Corp. (7733) rallied the most in six months in Tokyo trading after Terumo Corp. (4543) sought to out maneuver Sony Corp. (6758) by investing 50 billion yen ($640 million) and merging with the camera maker.
Olympus Corp. (7733) rallied the most in six months in Tokyo trading after Terumo Corp. (4543) sought to out maneuver Sony Corp. (6758) by investing 50 billion yen ($640 million) and merging with the camera maker.
Emily A Wood, Division of Vascular Surgery, Stony Brook University Medical Center, USA, spoke at the European Venous Forum Annual Meeting (28–30 June, Florence, Italy) on the results of a study that set out to quantify the incidence of inferior vena cava filter perforations of the inferior vena cava and surrounding structures and to assess the outcomes of filter perforations. The retrospective study found that the most common filter involved in perforating the inferior vena cava was the Bard G2. This was followed by the Bard Recovery and Cook Celect filters.
Back in April we provided an update on Californian company Crux Biomedical’s clever Vena Cava Filter (VCF), which ended with the promise of news to come about its then forthcoming FDA approval. Now the company has announced receipt of FDA clearance for its novel device which features bi-directional retrieval
Californian company Xlumena, Inc. has announced that it has received CE Mark approval to market its AXIOS Stent and Delivery System for biliary tract drainage. The device was previously approved for the treatment of pancreatic pseudocysts. This approval follows CE marking of Xlumena’s NAVIX™ Access Device, a multi-function system that enables exchange-free access, tract dilation and delivery of two guidewires during endoscopic pancreatic pseudocyst drainage
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