Vascular Solutions has announced the US market launch of Thrombidisc topical haemostat, a thrombin-based pad used as an adjunct to manual compression to control surface bleeding from vascular access sites and percutaneous catheters or tubes.
Benvenue Medical has received FDA 510(k) clearance for its Kiva system for the reduction and treatment of vertebral compression fractures. The system is a novel implant-based solution for vertebral augmentation and a departure from balloon kyphoplasty and, therefore, it is the first new approach to the treatment of vertebral compression fractures in over a decade.
ReCor Medical has announced that it has received CE-mark approval for the latest generation of its ultrasound-based renal denervation system (Paradise). It adds that the first patients were treated with the new system in December 2013 at the Universitäts–Herzzentrum, Bad Krozingen, Germany; the company also announced the first use of its new catheter line, called Radiance, which is 5 French and rapid-exchange compatible, and thus sized to be introduced via the radial artery (as opposed to the femoral artery).
Sapheon has announced that it has submitted the second module of the pre-market approval (PMA) application for the VenaSeal Sapheon Closure System to the US Food and Drug Administration (FDA). According to the company, the submission, which was completed on 18 December 2013, “represents steady progress on the modular PMA application for VenaSeal, a minimally invasive, single use kit intended for the treatment of venous reflux disease”. The first module, submitted in September 2013, was reviewed by the FDA and accepted without deficiencies within a single review cycle.
Argon Medical Devices announced that it has received clearance from the US Food and Drug Administration to begin marketing the Option Elite retrievable inferior vena cava filter with a new over-the-wire delivery technique on 16 January 2013.
CVRx has announced that findings from a health-economic analysis, published in the Journal of Hypertension, indicate Barostim therapy is a cost-effective treatment option for patients with drug-resistant hypertension. The Barostim system is a programmable, minimally invasive device that consists of an implantable pulse generator (IPG), a 2mm electrode, and an external programmer.
The Clínica Universidad de Navarra (CUN), Pamplona, Spain, recently celebrated its tenth anniversary of using Yttrium-90 (Y-90) microsphere radioembolization for the treatment of liver cancer. CUN was a European pioneer in the use of radioembolization, or selective internal radiation therapy (SIRT) with SIR-Spheres microspheres and has treated over 400 patients using the procedure.
A prospective single-arm, five-year study has found that CT-guided percutaneous cryoablation for renal cell carcinoma offers very high efficacy, approaching that of the gold standard, surgery. Cryoablation also has a more favourable safety profile.
Hepatic Oncology is published by Future Medicine Ltd, and joins its portfolio of oncology journals providing healthcare practitioners and research professionals with a unique source of objective, cutting-edge information on exciting trends emerging in light of advances in medicine, healthcare and clinical practice.
Medtronic’s sham-controlled renal denervation study, SYMPLICITY HTN-3, has failed to meet its primary efficacy endpoint of significantly reducing office blood pressure between baseline and six months in patients with treatment-resistant hypertension and systolic blood pressure of ≥160mmHg.
The latest recommendations, jointly issued by the Royal College of Obstetricians and Gynaecologists (RCOG) and the Royal College of Radiologists (RCR), has recently been published and are intended both for the National Health Service and the private sector.
An important opportunity has opened up for interventional oncologists as WCIO leaders take the helm of the E1208 trial. Michael C Soulen writes that the change in the trial leadership from medical oncology to interventional oncology represents a challenge because it rests on the question: can interventional oncologists run a successful cooperative group trial of image-guided therapy?
Medtronic has announced that the first patients were randomised in SYMPLICITY HTN-4, evaluating the Symplicity renal denervation system in patients with moderate uncontrolled hypertension (systolic blood pressure ≥140mmHg and <160mmHg, despite treatment with three or more antihypertensive medications of different classes).
At the recently concluded Radiological Society of North America (RSNA 1–6 December, Chicago, USA), Siemens introduced a new angiography system optimied for a broad clinical utilisation. Artis one is designed for routine interventions, which represent the majority of angiographic procedures. Energy consumption with the new system is up to 20% lower than with Artis zee floor.
Researchers from Oxford suggest that augmentation of the preclose technique (using Proglide from Abbott Vascular) with the Angio-Seal vascular closure device (St Jude Medical) is a safe and effective adjunct for haemostasis that increases the success of percutaneous endovascular aneurysm repair.
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