New data presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco, USA, demonstrate an excellent safety profile for Boston Scientific’s renal denervation system.
Uncontrolled hypertension is not the same as resistant hypertension. Experts at the third UK Symposium on Renal Denervation (16 October, London, UK) urged physicians to universally apply ambulatory blood pressure monitoring in order to help distinguish between the two and work within a multidisciplinary team to suitably select patients before offering the minimally invasive catheter-based procedure.
Surefire Medical announced the launch of a new, enhanced infusion system—the Surefire Infusion System mT—designed to treat vessels as small as 2mm to 3.5mm in interventional direct-to-target embolization procedures.
St. Jude Medical, Inc. (St. Paul, MN) announced new results from the EnligHTN I study that confirm safe, rapid, and sustained reduction in blood pressure measurements at 18 months after treatment with the company’s EnligHTN multielectrode renal denervation system. Professor Stephen Worthley, MD, from St. Andrew’s Hospital in Adelaide, Australia, a primary investigator in the EnligHTN I trial, presented the findings at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California.
Medtronic has announced that it has received investigational device exemption (IDE) approval from the FDA to conduct SYMPLICITY HTN-4—the first randomised trial to investigate renal denervation for the treatment of moderate uncontrolled hypertension in US patients.
On 29 October, Terumo Interventional Systems announced the launch of the 0.018” Glidewire Advantage peripheral guidewire during the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco, USA (27 October–1 November).
SYMPLICITY HTN-4 to potentially expand access for additional patients at risk for cardiovascular complications related to uncontrolled hypertension.
The Lotus Valve System (Boston Scientific) met a key performance measure in the treatment of symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement, according to new data released today at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco, USA (27 October–1 November).
The use of novel oral anticoagulants (NOACs) has increased rapidly in Ontario, Canada, especially in people aged 85 years and over, in the 2 years since the drugs were approved for use in patients with atrial fibrillation (AF), according to new research published in CMAJ Open. This rapid increase signals the need to evaluate outcomes from the use of these drugs in an elderly, high-risk population much older than the population involved in the studies.
The European Commission recently adopted two measures to improve the safety of medical devices. The newly adopted measures were announced on September 24 as part of the joint plan for immediate action agreed upon between the Commission and the European Union member states. An analysis of the measures was published on October 22 in The Wall Street Journal.
The results of a survey amongst medical device companies in Europe about the financial impact of the upcoming changes in the European medical device regulation show a significant increase in costs for bringing new devices to patients. In addition to the necessary €7.5 billion investment to ensure the safety of patients, an additional €17.5 billion would be necessary to finance a centralised pre-marketing authorisation system as proposed by the European Parliament’s Rapporteur.
NHS England is inviting specialist hospitals to take part in a new, innovative commissioning approach called ‘commissioning through evaluation’, which is aimed at increasing access to services or treatments which are not currently routinely funded by the NHS. The NHS revision of Clinical Policy Commissioning Statement on SIRT will allow patients in England with metastatic colorectal cancer and intrahepatic cholangiocarcinoma who may benefit from SIR-Spheres microspheres to get treatment in specialist NHS centres, a press release from Sirtex states.
AngioDynamics featured its key innovative products and technologies, including the Angiovac cannula and circuit, Bioflo peripherally inserted central catheters, the Nanoknife system, Nevertouch direct fibre and the Acculis microwave system at CIRSE 2013
At the European Society for Vascular Surgery Annual Meeting (18–21 September 2013, Budapest, Hungary), Abeera Abbas, Academic Surgery Unit, Institute of Cardiovascular Sciences, University of Manchester, UK, presented the results from a pilot study which suggested that 3D contrast-enhanced ultrasound may be more sensitive to detect endoleaks when compared to both CT angiography and 2D contrast-enhanced ultrasound.
Interventional News spoke to Tim A Fischell, professor of Medicine, Michigan State University, USA, about the first use of a novel, endovascular approach using chemical neurolysis via periadventitial injection of dehydrated ethanol to perform renal artery denervation. Catheter-based renal denervation is a novel treatment option for patients with resistant arterial hypertension
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