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.
Advanced magnetic resonance imaging (MRI) solutions combined with the innovative NeuroQuant software provides invaluable information to neurologists and radiologists
-- (Healthcare Sales & Marketing Network) -- Mazor Robotics, Ltd. (TASE: MZOR; NASDAQ GM: MZOR), a developer of innovative guidance systems and complementary products, announced that for the first time ever, a surgeon utilized Mazor Robotics Renaissance Guidance System to perform an Asleep Deep Brain Stimulation (DBS) procedure earlier this month at Littleton Adventist Hospital in Littleton, Colo.
ORLANDO, Fla.--(Healthcare Sales & Marketing Network)--On April 7, 2014, Mazor Robotics (TASE:MZOR; NASDAQ GM:MZOR) will debut and officially launch the new Renaissance Guidance System brain module at the American Association of Neurological Surgeons (AANS) annual meeting. The Renaissance system is FDA-cleared for both spine and brain surgery.
PLAINSBORO, N.J., April 4, 2014 -- (Healthcare Sales & Marketing Network) -- Integra LifeSciences Holdings Corporation (IART) today announced that the Camino(R) Flex Ventricular Catheter has received clearance from the United States Food and Drug Administration (FDA) for use with magnetic resonance imaging (MRI). The Camino Flex Ventricular Catheter is an advanced, tunneled ventricular catheter that is MR conditional at 1.5 and 3.0 T, with a sensor designed to measure directly at the source, and is used with Integra´s next-generation Camino(R) Monitor, which debuted in 2013. Integra is a leading provider of advanced intracranial pressure monitoring (ICP) systems. Over 800 centers in the United States use the Camino platform for conditions that cause an elevated intracranial pressure, including traumatic brain injury, subarachnoid hemorrhage, and stroke.
RALEIGH, N.C., April 10, 2014 -- (Healthcare Sales & Marketing Network) -- Baxano Surgical, Inc. (BAXS), a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the lumbar spine, today announced that it has received U.S. Food and Drug Administration 510(k) clearance (k133743) of its Avance(TM) MIS Pedicle Screw System, which may be used as an adjunct to fusion in numerous degenerative and complex spinal pathologies. The innovative design of Avance provides a quick and easy-to-use, percutaneous pedicle screw system that addresses single, complex and multi-level spinal pathologies with minimal tissue disruption and trauma. The Avance system will be in limited market release in the second and third quarter of 2014 and is planned for full launch in the fourth quarter of 2014.
LYON, France--(Healthcare Sales & Marketing Network)--The MEDICREA group (ALMED.PA) (Alternext Paris: FR0004178572-ALMED), a company that specializes in the development of innovative surgical technologies for the treatment of spinal pathologies, today announced the European launch of the UNiD, the world´s first patient-specific spinal osteosynthesis rod system.
IRVINE, Calif.--(Healthcare Sales & Marketing Network)--Reverse Medical® Corporation today announced FDA IDE approval for clinical investigation of their BARREL® Vascular Reconstruction Device (VRD). The BARREL® Vascular Reconstruction Device is designed for use with occlusive devices in the treatment of intracranial bifurcation aneurysms.
VISIUS intraoperative MRI significantly enhances amount of complete resection in brain tumors and leads to better patient outcomes.
ALACHUA, Fla.--(Healthcare Sales & Marketing Network)--RTI Surgical Inc. (RTI) (RTIX), a leading global surgical implant company, announced today the full market launch of the Streamline® OCT System. The system is designed to promote fusion of the occipto-cervico-thoracic spine (or occiput-T3). RTI received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the system in March 2014.
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