An urgent neurovascular device recall notice, new clinical data on interventional treatments for idiopathic intracranial hypertension (IIH), and landmark certifications of two stroke centres in India, all feature among NeuroNews’ most-viewed stories from March, while an in-depth interview with comedian and actor T.J. Miller also piqued the interest of many of our readers towards the end of the month.
1. Medtronic issues urgent recall of unused Pipeline Vantage 027 devices and updates IFU for Pipeline Vantage 021
Medtronic has issued an urgent medical device recall letter recommending that its customers do not deploy unused Pipeline Vantage 027 devices due to concerns over an increased risk of incomplete wall apposition and braid deformation. The company has also issued an update to the instructions for use (IFU) for its Pipeline Vantage 021 devices, advising that healthcare providers read and apply this updated IFU when completing any future procedures with these devices.
2. Safety of venous sinus stenting in IIH patients established via one-year RIVER study results
A prospective study has established the safety of venous sinus stenting (VSS) using a novel device in IIH patients who have failed standard medical therapy, as well as suggesting the potential efficacy of this approach.
3. TNKase gains US FDA approval for acute ischaemic stroke treatment
Genentech, a member of the Roche Group, has announced the US Food and Drug Administration (FDA) approval of the thrombolytic agent TNKase (tenecteplase) for the treatment of acute ischaemic stroke in adult patients. According to a company press release, this marks the first US FDA approval of a new stroke medicine for nearly 30 years.
4. US researchers discover new minimally invasive method for deep brain stimulation therapy
Researchers from Carnegie Mellon University and Allegheny Health Network in Pittsburgh, USA have developed a new method for deep brain stimulation (DBS). The technique, referred to as ‘DeepFocus’, uses trans-nasal stimulation to achieve more accurate electrical stimulation in the brain.
5. “Everyone just thought I was crazy”—T.J. Miller discusses life as a brain AVM survivor
Speaking exclusively to NeuroNews, comedian and actor T.J. Miller discusses his experiences as a brain arteriovenous malformation (AVM) survivor. Miller suffered a ruptured brain AVM in 2010 and, following a successful embolisation surgery, began to adjust to life with what he calls an “invisible disability”. However, it was only much more recently—after being approached by a representative from leading neurovascular device company Balt—that he started to take an active interest in how these AVMs are treated.
6. Penumbra launches Access25 delivery microcatheter designed for brain aneurysm access
Penumbra has launched the Access25 delivery microcatheter—a single-lumen medical device designed to aid physicians in accessing the neurovasculature for the delivery of Penumbra’s advanced 0.020-inch coil platform.
7. “First-of-its-kind” study demonstrates Monopoint system’s utility in IIH treatment
Route 92 Medical has announced the results of a “first-of-its-kind” multicentre study—published recently in Stroke: Vascular and Interventional Neurology—demonstrating the utility of the company’s Monopoint system in procedures to treat IIH.
8. Perfuze receives US FDA 510(k) clearance for Zipline access catheters and secures €22 million in funding
Perfuze has announced the receipt of US FDA 510(k) clearance for its Zipline access catheters—a regulatory milestone that the company claims will strengthen its growing portfolio of innovative neurovascular devices, empowering physicians to treat acute ischaemic stroke with greater speed, ease, and precision.
9. Apollo and Aster Hospitals become first in India to gain comprehensive stroke centre certification
The American Stroke Association (ASA) has awarded its first Indian comprehensive stroke centre (CSC) certifications to Apollo Hospital in Hyderabad and Aster Hospital in Calicut, in an effort to establish a coordinated system of stroke care across the country.
10. Stereotaxis seeks to broaden use of robotic magnetic navigation system into multiple endovascular fields
Stereotaxis has announced a US FDA regulatory submission for the first robotically navigated catheter designed to expand usage of robotic magnetic navigation into the broader endovascular field.
