ST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (STJ), a global medical device company, today announced it has received European CE Mark approval of its Eon™ family of neurostimulators for patients with intractable chronic migraine. Unveiled at the European Headache and Migraine Trust International Congress in London, this approval includes the Eon Mini™ neurostimulator, which is the world’s smallest rechargeable neurostimulator with the longest-lasting battery in its class, and the Eon and EonC™ neurostimulators. Preceding the Eon family approvals, the company received European CE Mark for its Genesis™ neurostimulation system, the industry s first regulatory approval for an implanted neurostimulation device to treat patients with intractable chronic migraine.
I must begin by pointing out that the year 2012 should be regarded as an exceptionally important anniversary in the history of interventional neuroradiology. It was 20 years ago that Guglielmi Detachable Coils were introduced for the first time—thus changing the philosophy of treatment of intracranial aneurysms completely. There is still a lack of clarity about the respective roles of endovascular and surgical treatment of aneurysms. Patients in different countries, or even different institutions, are offered various options. However, it is accepted that aneurysm rests and recurrences are more frequent after endovascular treatment than after surgical clipping. In just two decades, a major (r)evolution in medicine has taken place. Now, endovascular coiling is not only an alternative treatment, but regarded as “the gold standard” in the treatment of intracranial aneurysms.
New registry data shows 81% of patients had 90% or higher aneurysm occlusion after 21 months and only 8.3% required retreatment after stent-assisted coil embolization with the Codman Enterprise Vascular Reconstruction Device (VRD) and Delivery System (Codman Neurovascular).
In a late-breaking abstract session at CIRSE 2012, Marc Bosiers (AZ St-Blasius, Dendermonde, Belgium) presented the results of the ASTI trial, which showed the Adapt carotid stent (Boston Scientific)—with the FilterWire EZ distal protection catheter—to be a safe and effective treatment for patients with carotid artery stenosis who are at high-risk of carotid endarterectomy.
A small, experimental study, published in the American Journal of Neuroradiology (AJNR) in August, suggests that the Aperio System (Acandis Medical) seems to be an “efficient and safe” addition to the existing repertoire of clot-removal devices. The study compared the device with the Solitaire FR/AB (eV3/Covidien) device in a swine model.
Results from the Carotid Stenting Trialists’ Collaboration (CSTC) that were presented at the European Stroke Conference (ESC, Lisbon, Portugal) revealed that patients treated with stents that had a closed cell design were significantly less likely to suffer a periprocedural stroke or die when compared with patients treated with stents with an open design. The study also revealed that embolic protection devices did not reduce the occurrence of symptomatic cerebral thromboembolic events.
Once-daily oral rivaroxaban recommended by European Society of Cardiology (ESC) as a first line therapy option with a comparable efficacy and safety profile to warfarin for the prevention of stroke and systemic embolism in eligible patients with non-valvular atrial fibrillation (AF)1
Indirect comparison based on the RE-LY trial for dabigatran etexilate and the ROCKET-AF trial for rivaroxaban suggests advantages of dabigatran in stroke prevention in patients with atrial fibrillation.
On 24 August, the UK s National Institute of Health and Clinical Excellence (NICE) released a draft guidance updating its previous recommendations on the use of alteplase (Actilyse, Boehringer Ingelheim) for the treatment of acute ischaemic stroke. NICE has recommended alteplase within the NHS as long as treatment is started as early as possible within 4.5 hours after onset of stroke symptoms, and after intracranial haemorrhage has been excluded by appropriate imaging techniques.
Codman Neurovascular has announced the launch of the Deltamaxx Microcoil System, and Orbit Galaxy G2 Microcoils, which for the first time puts Orbit Galaxy coils on the EnpowerDetachment System, developed by Micrus Endovascular. Both new microcoil systems are now available in the United States and Europe.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Stryker for its Trevo Pro Retriever, a clot removal technology designed to treat patients experiencing acute ischaemic stroke.
Interim results from the START trial, presented at Society of NeuroInterventional Surgery (SNIS, San Diego, USA) 9th Annual Meeting, show advancement in predicting which patients suffering from ischaemic stroke will benefit from endovascular therapy.
Interim results from the START trial, presented at Society of NeuroInterventional Surgery (SNIS, San Diego, USA) 9th Annual Meeting, show advancement in predicting which patients suffering from ischaemic stroke will benefit from endovascular therapy.
The US Food and Drug Administration (FDA) has announced changes to the labeling, including to the indications for use of the Wingspan stent (Boston Scientific/Stryker), which limit its use to a narrow, select group of patients diagnosed with intracranial stenosis.
On 8 August, UK s National Institute of Health and Clinical Excellence (NICE) released a guideline to encourage detailed assessments to people who have neurological conditions like stroke, multiple sclerosis and head and spinal cord injuries, and who experience incontinence or other urinary problems.
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