“Performing a randomised control trial (RCT) is a huge burden and also very expensive, for researchers as well as patients. Despite good designs, they often fail. So, with INSIST, we aim to generate a platform to perform the trials in silico through computational modelling and simulation technologies. We now have computer simulations, which are standard technology in many industries like automotive, aeronautics or engineering, but they are really underestimated for the health care setting. INSIST is based largely on existing databases like the MR CLEAN trial and MR CLEAN registry. We have generated a virtual population model, which is an effective covariant distribution model, incorporating all relevant patient parameters that may account for the differences between those individuals. We also generated models to simulate thrombosis and thrombolysis, thrombectomy, and models simulating tissue fate during and following ischaemic stroke. We have also generated a platform for in silico trials.”
3D printing technology is widely used in the field of implantable medical device in recent decades because of its advantages in high precision, complex structure, and high material utilization. Based on the characteristics of 3D printing technology, this paper reviews the manufacturing process, materials, and some typical products of 3D printing implantable medical devices and analyzes and summarizes the development trend of 3D printed implantable medical devices.
One of our favorite examples of science-as-art is the vascular corrosion cast: a physical replica of an explanted organ’s internal vascular networks made by first injecting the vasculature with plastic resin, then chemically degrading the original tissue (Fig. 1). These captivating structures remind us of the spectacular architecture woven throughout nature, but in our research group, they also serve as goalposts for our ongoing efforts in vascular biofabrication.
A multicentre study has reported that clot perviousness or permeability, the ability for contrast used during the initial imaging workup to seep through a clot, as estimated by computed tomography (CT) imaging, is associated with ”first-pass success” in large vessel occlusion (LVO) strokes initially treated with an aspiration thrombectomy approach.
Cerenovus, part of Johnson & Johnson Medical Devices Companies, has today announced the European launch of Cerenovus Nimbus, a device designed to remove tough clots for successful revascularisation in patients with acute ischaemic stroke caused by a large vessel occlusion.
The Stentrode brain-computer interface (BCI) has successfully been demonstrated by researchers to help patients with severe paralyses compete tasks such as texting, emailing, shopping and online banking, in a new study. The BCI does this without the need for open brain surgery.
A study published in the British Medical Journal (BMJ) has found that first-pass effect (FPE), restoring complete or near complete reperfusion (modified Thrombolysis in Cerebral Infarction [mTICI] 2c-[SM1] 3) in a single pass, used as an endovascular treatment of acute ischaemic stroke, not only provides better clinical results, but also lowers health costs. Researchers found a lower cost potential per stroke patient annually, in every country studied.
Attorney Becca Timmons joins Mike Papantonio to explain an emergency recall by the FDA for a popular catheter used to remove blood clots during brain surgery. Manufactured by Penumbra, the faulty device has actually caused ruptured arteries, strokes, and even death.
Rapid Medical has announced CE mark approval for Tigertriever XL stentriever. The company noted that the first patients have been treated successfully with the neurovascular device.
The proposed indication for use includes: “The MagicTouch SCB Sirolimus coated balloon catheter is indicated for percutaneous transluminal coronary angioplasty, after appropriate vessel preparation, of small coronary artery lesion lengths of 6‒36mm in coronary arteries with reference vessel diameters of 1.50‒2.75mm.”
Rapid Medical states that, with Drivewire, physicians control the direction and shape of the guidewire’s tip while it is inside the vessel, precisely navigating the neuro and peripheral vasculature. Rapid Medical add that this intravascular steering provides access to difficult anatomical locations, increasing the physician’s ability to treat vascular diseases with less invasive interventional approaches.
“We recognise that not all neurovascular interventions can be displaced by robotic surgery due to the complexity of vascular and aneurysm anatomies, however this accomplishment does demonstrate promise for procedures to be performed like this in the future. The Contour device is positioned as an easy to use ‘one and done’ solution, which we believe makes this a very realistic application for robotic surgery, as Nitin Dange has clearly demonstrated.”
Study of 12,128 patients over 5 years showed automated AI measurement of visceral fat area on abdominal CT images predicts future heart attack or stroke risk better than overall weight or BMI
Coils have the potential to introduce undesirable point or localised forces on the aneurysm wall which can lead to an IAR. The incidence rate of IAR is low but the mortality rate associated with such complications remains high. Causes of IAR are likely multifactorial and may be related to characteristics of the aneurysm such as wall thickness or integrity as well as properties of the procedure such as catheter tip position. For example, it is possible that a very soft, small coil can perforate an aneurysm if deployed through a catheter tip that is pinned against an aneurysm wall (immediately apposed to the dome). IAR rates as reported in the literature have found no specific correlation related to coil type (framing, filling, finishing) and sequence. IAR rates are somewhat dependent on aneurysm location10, and size.
The UK-based startup Proximie, which has developed an augmented reality tool to save lives by allowing senior surgeons to virtually climb into any operation theatre across the globe, has seen a 430% increase in surgeries this year. Since being founded by the NHS surgeon Dr Nadine Hachach-Haram in 2016, the startup has managed to attract 2,500 users across 300 hospitals and has had its tool used in over 7,000 surgeries.
Neurovascular intervention is an approach for the treatment of neurological disorders and neurovascular diseases that affects the central nervous system. It is also used for the treatment of associated blood vascular systems using minimally invasive procedures. Neurological medical devices have been broadly classified into Neuro-stimulation Devices, Interventional Devices, Cerebral Spinal Fluid (CSF) Management Devices and Neurosurgery Devices.
Traditionally, stent-assisted coiling and balloon remodeling have been the primary endovascular treatments for wide-necked intracranial aneurysms with complex morphologies. PulseRider is an aneurysm neck reconstruction device that provides parent vessel protection for aneurysm coiling. The objective of this study was to report early postmarket results with the PulseRider device.
Sphenopalatine ganglion stimulation is safe for patients with acute ischaemic stroke 8–24 h after onset, who are ineligible for thrombolytic therapy. Although not reaching significance, the trial's results support that, among patients with imaging evidence of cortical involvement at presentation, sphenopalatine ganglion stimulation is likely to improve functional outcome.
The ANA™ thrombectomy system is a novel stroke thrombectomy device comprising a self-expanding funnel designed to reduce clot fragmentation by locally restricting flow while becoming as wide as the lodging artery.
Donald Ricci, president and Chief Executive Officer of Evac commented, “We have listened to the experts in the neuro field and developed an improved version that is smaller and easier to use. This will allow treatment for a wider range of aneurysms and shorten delivery times,” he continued, “The previous version showed exceptional outcome due to the eCLIPs implant’s ability to bridge the neck of the aneurysm and to create a flow diversion effect. This new and improved version retains these favourable characteristics and also allows eCLIPs to gain access to smaller and more distant vessels within the cerebral anatomy.”
The FDA reports receiving over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunctions. Twenty of these MDRs describe 14 unique patient deaths, which include reports from different reporting sources for a single adverse event. Penumbra report a total of 17 events involving patient injury, of the 30,000 distributed units. Other MDRs describe serious patient injury such as vessel damage, haemorrhage, and cerebral infarction. Device failure modes reported in the MDRs include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.
During this course EMS providers will be introduced to LVO stroke, as well as a sample of stroke severity scales that are intended to accurately predict LVO stroke in the field. This course will also present how EMS providers can improve prehospital stroke screening, documentation, and communication with receiving stroke centers.
HPC is an aneurysm implant and Flow Diverter coating, which shall reduce the risk of thrombosis on the surface of stents. Due to the thrombogenic surface, platelet function-inhibiting drugs are needed to prevent in-stent thrombosis. The current solution of preventing platelet activation is the Dual Anti-Platelet Therapy (DAPT) consisting of Aspirin and Clopidogrel.
Rapid Medical has announced that its adjustable remodelling mesh device, called Comaneci, has received CE mark approval. Comaneci is intended to treat cerebral vasospasm by mechanically dilating the intracranial vessels.
BEEYOND is a consulting company in the field of disruptive innovation, accompanying established companies on out-of-the-core growth strategy, from creation of new concepts to product launch. Reach us at: contact@beeyond.fr.
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