The Apollo system, manufactured by Penumbra, has been widely launched following first-in-man clinical use at leading US hospitals.
A combined approach with the Penumbra aspiration system (Penumbra) and the Solitaire FR retrieval device (ev3, Covidien) has been successfully used in a patient with extensive superior sagittal sinus thrombosis and cortical venous thrombosis, according to a case report.
A new national centre of excellence for the treatment of epilepsy in Scotland, which integrates health care with social care, has recorded a 100% success rate in its first year.
New evidence shows that the omega-3 polyunsaturated fatty acids (PUFAs) found in seafood and marine oils, DHA and EPA, can significantly reduce damage from stroke in a mouse model when given immediately afterwards. Moreover, DHA and another PUFA demonstrate a positive effect on neurocognitive function in children. These findings and more were presented 29-30 June at the 11thCongress of the International Society for the Study of Fatty Acids and Lipids (ISSFAL) in Stockholm, Sweden.
The American Heart Association is funding a new research network to help people make behaviour changes to prevent heart disease and stroke, the two leading causes of death in the world.
Covidien announced the European launch of its Pipeline Flex embolisation device at the annual Live Interventional Neuroradiology and Neurosurgery Course (LINNC, 23–25 June, Paris, France). This next-generation flow diversion device received CE mark earlier this year.
Royal Philips has announced the introduction of NeuroSuite, a new integrated solution designed to support and enhance minimally invasive image-guided neurological interventions. Philips’ new interventional X-ray solution offers more effective device guidance and placement in every neuroradiology procedure.
Airo Mobile Intraoperative CT, developed and manufactured by Mobius Imaging and distributed by Brainlab, was awarded gold in the Radiological and Electromechanical Device category of the 17th Annual Medical Design Excellence Awards (MDEA) competition. Award winners were announced on June 11, 2014 at MD&M East’s main networking event—the 2014 Medical Design Excellence Awards ceremony held in New York. This distinction comes just months after Airo was honoured with a 2014 Red Dot Product Design Award.
Researchers at the Allen Institute for Brain Science have mapped the development of the mouse brain from the embryo to the adult, creating a preliminary genetic key that allows them to pinpoint the age and location of regions of the developing brain. This work lays the foundation for tracking regions of the mouse brain through development, which could have valuable implications for translational work in human brain developmental disorders. The research, profiling the publicly available Allen Developing Mouse Brain Atlas, is published in the journal Neuron.
Silk Road Medical has announced the completion of enrolment in its pivotal ROADSTER study. The trial was the first of its kind to study the treatment of carotid artery stenosis by placing a stent via direct access to the common carotid artery in the neck in an entirely new minimally invasive procedure. The device under study is the company’s Enroute transcarotid neuroprotection system which incorporates proven surgical principles to protect the brain from a stroke during carotid angioplasty and stenting, and features a mechanism to divert dangerous debris away from the brain by temporarily reversing blood flow. Data from the trial will be used to support 510(k) clearance of the Enroute transcarotid neuroprotection system as well as pre-market approval of the Enroute transcarotid stent system.
June 11, 2014—Covidien announced US Food and Drug Administration (FDA) approval of its Apollo Onyx delivery microcatheter. The detachable-tip microcatheter is designed to mitigate the technical challenges of catheter retrieval during Onyx liquid embolic system (LES) embolizations of brain arteriovenous malformations (bAVMs).
June 10, 2014—Pulsar Vascular announced that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for the PulseRider, the company’s minimally invasive aneurysm neck reconstruction device. The IDE allows Pulsar Vascular to begin a multicenter clinical trial in support of a humanitarian device exemption to evaluate the PulseRider for United States approval for wide-neck aneurysms at or near a bifurcation of the basilar tip or carotid terminus.
Pulsar Vascular has announced that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for the PulseRider. The IDE allows Pulsar Vascular to begin a multicentre clinical trial in support of a humanitarian device exemption (HDE) to evaluate the PulseRider for US approval for wide neck aneurysms at or near a bifurcation of the basilar tip or carotid terminus. There are currently no devices approved by the FDA for this indication.
Covidien (Mansfield, MA) announced that it has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline embolization device and Alligator retrieval device, in which the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices. Delamination of the PTFE coating could potentially lead to embolic occlusion in the cerebral vasculature, with the risk of stroke or death. The PTFE coating is used to reduce friction between devices and ease navigation through the vasculature.
RICHLAND, WA--(Healthcare Sales & Marketing Network) - IsoRay Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced Isoray has received final approval from the State of Washington Department of Health to manufacture its recently FDA cleared Liquid Cesium-131 (Cesitrex®) for use with GliaSite® balloon catheter for the treatment of metastatic and glioblastoma brain cancers.
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