Penumbra has announced that the company’s ACE64 aspiration thrombectomy system received 510(k) marketing clearance from the US Food and Drug Administration for the revascularisation of large vessel occlusions in patients with acute ischaemic stroke.
In 2009 I became president of the International Neuromodulation Society (INS). I realised then that the INS had to brand the term neuromodulation in order to support the broad acceptance of a diverse range of neurostimulation therapies within the dogma of medical practice and wider health economy. The three biennial congresses that followed in London 2011, Berlin 2013 and Montreal 2015 each had a strap line that were written in the present tense and linked innovative technological medicine with chronic disease management and care that put patients at the centre of their care: “Technology that Improves Patient Care”, “Technology Transforming Chronic Illness Management”, and “Medicine evolving through Technology”. These phrases also capture the sense that medical practice and our understanding of disease management is changing and will change more.
Recently no less than five randomised controlled trials showed superiority for intra-arterial treatment added to intravenous thrombolysis (IVT) of large artery stroke in the anterior circulation as compared to stand-alone IVT1–5. This obvious breakthrough is more than welcomed, but it is also clear from these studies that challenges remain, not least for the neurointerventionalists. In all the studies, the revascularisation percentage was far from 100% (Figure 1); sometimes it is quite impossible to remove the thrombus in a safe and efficient way. Further, even if perfect revascularisation is achieved, the percentage of patients having a good outcome is much less. Such so-called futile revascularisation has probably many reasons, but one of them may be a prolonged procedure time.
To conduct the analysis, investigators from both trials assessed the effect of endovascular treatment in acute ischaemic stroke patients with severe neurological deficit (National Institutes of Health Stroke Scale [NIHSS] score, ≥20) after a prespecified analysis plan.
Stent retriever technology has been named by the Cleveland Clinic as a top medical innovation. It was part of a list of the top medical innovations for 2015, revealed at the Cleveland Clinic’s 2015 Medical Innovation
Blockade Medical LLC has announced the closing of a round of equity financing. The financing was comprised of existing investors and new investment from TitanMed Capital and GP Healthcare Capital, venture capital and private equity funds, which are dedicated to healthcare investments. The company also announced the formation of a joint venture for future manufacturing of Blockade devices for the Chinese marketplace.
No safety concerns were identified at this pre-planned safety review of the trial, and the DSMB recommended that the study should continue as planned.
Insightec has announced that it has submitted a pre-market approval application (PMA) to the US Food and Drug Administration (FDA) for its Exablate Neuro treatment of essential tremor.
A 30-patient study, presented at Neuroscience 2015, has found that magnetically stimulating part of the brain hemisphere unaffected by stroke can affect transient changes in patients with severely disabling post-stroke arm impairment. The study is the first to focus on the transient changes produced in stroke-affected arms by transcranial magnetic stimulation (TMS).
Silk Road Medical has announced the receipt of up to US$57 million investment in the form of equity and debt funding from new and existing investors. CRG joins Warburg Pincus and The Vertical Group as an equity investor, and has led the debt financing.
Pulsar Vascular has announced that they have reached the target enrolment in their clinical trial for PulseRider device for the treatment of intracranial aneurysms. This multicentre study was conducted under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA) at 10 centres of excellence nationwide.
EpiWatch is an epilepsy research study monitoring seizure symptoms using Apple Watch with an aim to improving seizure detection and medication adherence, as well as enhancing the quality of life for those who suffer from seizures.
Seven centres are first in the USA to order the Leksell Gamma Knife Icon, which will soon be available to patients with brain cancer, or any of a range of other neurological disorders. Icon features the first integrated stereotactic cone beam CT imaging, online adaptive dose evaluation and planning enabling, according to Elekta, the most accurate delivery of frameless and frame-based treatments.
Sequent Medical has announced that the US Food and Drug Administration has approved the inclusion of WEB .021” devices for use in its US Investigational Device Exemption (IDE) clinical study called WEB-IT. The .021” devices represent the latest generation of WEB technology, and are delivered through a downsized version of the company’s existing VIA microcatheter, the VIA 21.
Medtronic plc has announced that it has acquired Lazarus Effect, a Campbell, California, USA-based and privately-held medical device company focused on acute ischaemic stroke products that facilitate the capture and removal of clots.
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