Neuro

The Left Atrial Appendage is a troublesome little design feature. It doesn’t appear to possess any purpose and can be the source of clots, especially in AF patients, leading to an attendant stroke risk. So let’s block it off? Eu regulators seem happy with that idea, U.S. less so, which again shows up our differences.

“Super therapy” renal denervation may favourably impact major cardiac events and a new study hopes to demonstrate to what extent. We’ll be fascinated to see the results and are betting the house on the fact that there is a positive effect.

Presentation of neurological data confirms patients in the device group had fewer, smaller strokes that were less likely to originate from blood clots passing through the PFO

Interventional Neurology’s on-off relationship with mechanical thrombectomy might be back on with this solid looking data from Covidien’s STAR study into the safety and efficacy of the Solitaire FR device in AIS patients.

Medtronic is trumpeting the European introduction of the first and only implantable neurostimulation systems indicated for use in the treatment of chronic back and/or leg pain that are designed for full-body MRI scans under specific conditions.

Infrascan gained FDA approval in late 2011 for its noninvasive haematome detection device. Now, as is the way of things, version 2 has gained the agency’s nod, featuring a more “ruggedized” build for military and other field operations.

The first patient has been recruited to a new clinical trial, which represents one of the largest global studies to examine the effectiveness of an advanced mechanical treatment in stroke care.

Drug resistant depression is a problem with a new solution in the U.S. now that the FDA has given Brainsway’s non invasive magnetic stimulation device the nod.

St. Jude Medical, Inc. revenues for the quarter just ended again showed a decline compared with the equivalent period a year ago, although the drop-off was overall slightly less marked than it had been in Q3. And the bottom line held up as cost saving measures played out.

Nexstim’s Navigated Brain Therapy (NBT) System has gained CE mark clearance, becoming the first non-invasive, non-systemic therapeutic device CE-marked to offer patients a personalised treatment for major depression and stroke rehabilitation.

Covidien’s eV3 subsidiary business brought with it the Pipeline embolisation device when it was acquired. While the device shows encouraging results in patients with certain types of difficult-to-treat brain aneurysms, a new report suggests there are also reasons for some caution over fatal bleeds.

NeuroMetrix, Inc., a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, has received 510(k) clearance from the U.S. FDA for the disposable electrode that is used in conjunction with its Sensus device.

U.S. device company Bracco Diagnostics has issued a voluntary Class I recall of its Isovue® (iopamidol injection) Pre-Filled Power Injector Syringes. It seems particles have been found in certain lots, with the obvious concern about stroke risk should any of these find there way into the cerebral vasculature.

Registry data collected from patients undergoing treatment with Wingspan under US Humanitarian device exemption approval has resulted in FDA issuing more limited indications for use. Yet in Europe we seem to be burying our heads in the sand on the device’s shortcomings.

Watch a lovely video of Stryker’s newly released clot-catching Stentriever, called Trevo® ProVue™ because it can be viewed fluoroscopically during the process.

We don’t know what it’s about, but it’s obviously material enough to warrant Integra going to press with the news that it has received a warning letter from the FDA following the agency’s audit of its UK facility earlier this year.