Neurosurgery
FDA: Class I recall of Zimmer Biomet’s ROSA Brain 3.0 Robotic Surgery System
Editor's Note The Food & Drug Administration on November 7 identified the recall by Zimmer Biomet of its ROSA Brain 3.0 Robotic Surgery System as Class I, the most serious. The recall was initiated because of a software issue that incorrectly positions the robotic arm. The company has received five…
FDA: Class I recall of Integra LifeSciences CSF drainage, ICP monitoring systems
Editor's Note The Food & Drug Administration on May 24 identified the recall by Integra LifeSciences of its LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and the MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring System as Class I, the most serious. The recall was initiated because of…
FDA grants Stryker premarket approval for intracranial aneurysm stent
Editor's Note Stryker announced on May 20 that the Food & Drug Administration (FDA) granted premarket approval for its Neuroform Atlas stent system for intracranial aneurysms, the May 20 MassDevice reports. The self-expanding nitinol stent can now be used with neurovascular embolization coils to treat patients with saccular wide-necked…
FDA: Class I recall of Neuro Omega System
Editor's Note The Food and Drug Administration (FDA) on May 6 identified the recall my Alpha Omega Engineering of its Neuro Omega System, including the Drive Headstage unit, as Class I, the most serious. The recall was initiated because a design flaw in the device may connect two separate electrode…
FDA issues Safety Communication for Stryker Wingspan Stent System
Editor's Note The Food and Drug Administration (FDA) on April 25 issued a Safety Communication on use of the Stryker Wingspan Stent System outside of approved indications. The Wingspan Stent System is used to open narrowed arteries in the brains of patients with intracranial stenosis who are experiencing repeated strokes.…
FDA: Class I recall of Medtronic’s Synergy, Stealth Station S7 Cranial Software
Editor's Note The Food & Drug Administration (FDA) on January 8 identified the recall of Medtronic’s Synergy Cranial Software and Stealth Station S7 Cranial Software as Class I, the most serious. The Software is used with the Stealth Station Surgical Navigation System to provide detailed 3D images of a patient’s…
FDA: Class I recall of Synaptive Medical’s BrightMatter Guide with SurfaceTrace Registration
Editor's Note The Food and Drug Administration (FDA) on November 30 identified the recall by Synaptive Medical of its BrightMatter Guide with SurfaceTrace Registration, which is used to perform neurosurgical procedures, as Class I, the most serious. The recall was initiated because of a software defect that could potentially result…
FDA sends letter to healthcare providers on neurovascular stents
Editor's Note The Food and Drug Administration (FDA) on May 8 sent a letter to healthcare providers that included recommendations on the use of neurovascular stents for stent-assisted coiling in the treatment of unruptured brain aneurysms. The FDA has received reports associated with these devices that suggest events of peri-procedural…
Allowing overlapping surgery for urgent neuro cases decreases length of stay
Editor's Note A change of policy to allow the practice of overlapping surgery for urgent neurosurgical procedures in a tertiary care, safety-net hospital significantly reduced length of stay, in this study presented May 1 at the American Association of Neurological Surgeons in New Orleans. Of 452 cases analyzed (201 in…
FDA issues Safety Alert for magnetic resonance-guided laser interstitial thermal therapy devices
Editor's Note The Food and Drug Administration (FDA) on April 25 issued a Safety Alert that provides preliminary information concerning magnetic resonance (MR) thermometry reliability with MR-guided laser interstitial thermal therapy (MRgLITT) devices. The FDA is evaluating data that suggests potentially inaccurate MR thermometry information can be displayed during treatment,…
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