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.
Emory Saint Joseph’s Hospital, Atlanta, USA, is improving treatment for stroke patients with the launch of a Telestroke programme, which allows neurologists to remotely evaluate patients around the clock through real-time conferencing with a Telerobot monitor.
Monteris Medical has announced recent data demonstrating that newly diagnosed brain tumour patients undergoing procedures with the NeuroBlate system, a minimally invasive robotic laser thermotherapy tool, experienced improved outcomes. These findings, along with a separate case study presentation highlighting the first successful ablation of the hippocampus and amygdala using a directional laser, were presented during the 2015 Congress of Neurological Surgeons Annual Scientific Meeting (26–30 September, New Orleans, USA).
One of the newest devices to surface for the treatment of acute ischaemic stroke is the EmboTrap from Neuravi. At the World Live Neurovascular Course (WLNC; 8–10 June, Chicago, USA) Osama Zaidat (Medical College of Wisconsin, Milwaukee, USA) and Tommy Andersson (AZ Groeninge, Kortrijk, Belgium and Karolinska University Hospital, Stockholm, Sweden) introduced the device and presented the results of the first 25 cases performed by Andersson and the team at Karolinska in Sweden.
In the first study to be published reporting on endovascular aneurysm treatment with the p64 flow modulation device (Phenox), Francesco Briganti and colleagues have found that the device provides a safe procedure with no technical complications.
While the traditional unsheathing technique for the deployment of stent retrievers has proved successful in clinical use, in their experience, Raul Gomes Nogueira (Emory University School of Medicine, Atlanta, USA) and colleagues have developed a new technique for the deployment of the Trevo ProVue stent retriever (Stryker Neurovascular) that they have found produces better results than the traditional technique. At the Society of NeuroInterventional Surgery 12th Annual Meeting (SNIS; 27–30 July, San Francisco, USA), Nogueira presented the Push & Fluff technique and he now speaks to NeuroNews about how it was developed and the results they have seen so far.
InspireMD announced the full market launch of the CGuard Embolic Prevention System for the treatment of carotid artery disease by its strategic distribution partner, Penumbra, at the CIRSE Annual Congress (26–30 September, Lisbon, Portugal). Penumbra leverages its direct European commercialisation team to launch CGuard distributed by Penumbra.
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