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Product Review: WEB Embolization System

Healthcare | Apr, 2021

Wide-necked bifurcation cerebral aneurysms have always been challenging to treat and have historically required either a surgical clip, stent, or balloon-assisted coil embolization. This predicament to preserve major bifurcation vessels while achieving a double occlusion of the aneurysm led to the development of Woven EndoBridge (WEB) aneurysm embolization system. The WEB device is an intrasaccular braided wire designed to disrupt blood flow through the aneurysm ostium for the treatment of intracranial wide-neck bifurcation aneurysms. Reconstructing the aneurysm neck interface with a low-porosity metal mesh, the WEB system initiates thrombosis and provides a robust lattice for subsequent nonendothelial tissue overgrowth. The tightly packed, permanent nitinol-based mesh material comes in different variants to treat a broad range of aneurysms, including bifurcation-type morphologies, without placing adjacent perforating arteries at risk. 

 

The WEB System is a first-to-market, innovative, and extensive intrasaccular solution that causes prompt aneurysm occlusion, which makes it appropriate for the treatment in ruptured aneurysms. The WEB embolization system is a self-expanding mesh, composed of inner and outer braids held together by the proximal, middle, and distal radiopaque markers. Depending on the device, the inner and outer layer of the mesh consists of 108 0r 144 wires, so the blood flows into the WEB-embolized aneurysm has to encounter two layers of 216 or 288 wires arranged at a distance of 106 or 147 μm, respectively. Like other conventional endovascular coil systems, WEB implant is also deployed using microcatheters. The device system consists of a controller, that is used to detach the device from the delivery wire once positioned appropriately. 

 

The Woven EndoBridge aneurysm embolization system is the only FDA-approved device for the treatment of ruptured and non-ruptured wide-necked aneurysms. Small aneurysms with angulated access can be the most challenging but the WEB solution has a variant for them as well. With the greater softness of the device, the WEB 17 system is ideal for aneurysms with extreme angulation at the parent/aneurysm interface. The WEB 17 system is placed through steam shaping the VIA microcatheter, which has great flexibility and helps in catheterizing aneurysms. 

 

The WEB Aneurysm Embolization System is indicated for use in middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA), anterior communicating artery (ACA), and basal artery apex in adult patients. The device is FDA-approved for the treatment of intracranial aneurysms with dome diameter ranging from 3 mm to 10 mm and neck size equal to or greater than 4 mm. However, the device is not to be used in patients with known active bacterial infection and hypersensitivity to nickel. The Woven Endobridge (WEB) system cannot be used in large or giant aneurysms greater than 10 mm because the largest device diameter is 11X9.6 mm. 

 

WEB system is a safe and effective treatment option, that provides excellent clinical outcomes with fast procedural time and limited radiation exposure. Demonstrating 84.6% adequate occlusion and extraordinary safety profile for aneurysms that are challenging to treat with standard embolization devices, the WEB system has become a valuable alternative for physicians to treat bifurcation aneurysms. Some other diagnostic interventions include the use of small metal clips on the neck of the aneurysm, embolic coils, flow disruptor stents with the help of a catheter in the blood vessel. Patients who cannot undergo surgical clipping can opt for the new and unique intravascular device, WEB system to treat intracranial wide-neck bifurcation aneurysms. 

 

Once placed inside the aneurysm sac, the WEB device’s proprietary microbraid technology self-expands by gently pushing off the nearest wall into the center of the aneurysm to conform to the sac shape without needing other devices. From device insertion to withdrawal, the procedure takes around 20.9 minutes on average. The single-device treatment alternative to endovascular coils is a long-lasting treatment for intracranial aneurysms, creating a scaffold by bridging the aneurysm neck for disrupting blood flow. The WEB system has been used safely in over 10,000 cases throughout the world, but the device is available for sale in the only US and Japan currently. 

 

The WEB system device has a high success rate, but it is not ideal for everyone. The device is not suitable to treat an intracranial aneurysm in patients who

· Are less than 18 years old

· Are not capable to undergo general anesthesia

· Are pregnant

· Has a renal insufficiency

· Does not have aneurysm with dome-to-neck ratio ≥ 1

· Is non-compliant or presents an unstable psychiatric history

 

The WEB device has evolved from a dual-layer version to high visibility single-layer versions such as WEB SLS and WEB SL. While WEB SLS treats bifurcation aneurysms with a fundus to create a spherical appearance, the WEB SL device is barrel-shaped to accommodate cylindrical bifurcation aneurysms in which the neck width and diameter are similar. Appropriate WEB device selection is important for the success of the treatment so physicians can choose between SL or SLS based on the aneurysm size, neck, and dome morphology. The WEB device is retrievable and can be exchanged for a different size or shape if the original is not optimal for the aneurysm. Inadequate compression is associated with an increased risk of aneurysm recurrence therefore the device width should be oversized compared to the diameter of the aneurysm in order to release radial force throughout the surface of the aneurysm wall. 

 

Dual antiplatelet administration is not required with the WEB devices whereas open surgical clipping needs dual antiplatelet agents for adequate occlusion of the rupture site. However, in some cases with large aneurysm neck, antiplatelet medications can be initiated. Also, for elective embolization, pre-treatment with effective antiplatelet therapy may lower the risk of thromboembolic complications. Post-procedure, the patients are often administered low-dose aspirin rather than antiplatelet therapy in many straightforward cases. 

 

Complications

The WEB deployment involves a risk of rupture of aneurysm however, it is a rare occurrence. Usually, the rupture can occur when the constrained WEB device first exists the microcatheter or an unanticipated forward pressure is stored within the VIA microcatheter and delivery system. Once the device is deployed inside the aneurysm, there is a very unlikely probability of rupture. The patient might develop aneurysm recurrence and require retreatment in case of device migration and WEB device compaction. Device migration happens when the WEB device transcends from the initial site of placement into the aneurysm sac, but the size of the device remains unchanged. This phenomenon occurs either due to under-sizing the device or an improperly chosen device or partially thrombosed aneurysms. WEB device compaction means a decrease in height of the device with deepening of the marker recess at both sides, which results from cicatrization within the aneurysm fundus. 

 

Other EndoSaccular Flow Disruptor Devices

PulseRider

The PulseRider is another novel endovascular device designed for treating wide-necked bifurcation aneurysms. Just like the WEB embolization system, the PulseRider is self-expanding nitinol impact, which acts as a neck bridge to disrupt blood flow. The PulseRider has a unique frame configuration and is specifically designed to preserve luminal patency and hemodynamic flow through the parent vessel bifurcation. 

 

pCONus 

The pCONus is an electrolytically-detachable and re-sheathable, self-expanding stent-like device that deploys within the aneurysm and bridges its neck. The shorter shaft provides reliable stability and a stent-like structure secure anchoring and long-term stability. pCANvas is a new derivative of the pCONus with an added feature of membrane between each petal fabricated to augment the neck-bridging effect. 

 

The durability and safety of endovascular treatment for intracranial aneurysms can be enhanced by eliminating the need to catheterize branch vessels for deployment, which may be considered advantages of the PulseRider, pCONus, and pCANvas devices and limitation of WEB embolization system. Application of the PulseRider or pCONus offers two potential advantages for aneurysm neck reconstruction such as eliminating the need for catheterizing blood vessels while deploying the devices in the aneurysm and lack of dual antiplatelet therapy. However, intrasaccular flow disruption at the aneurysm neck without any neck reconstruction devices simplifies the treatment and reduces the number of steps to the procedure. 

 

Conclusion 

The treatment modalities for endovascular treatments of intracranial aneurysms have evolved in the past three decades. The detachable balloon was the first reliable technique, but a high rate of secondary deflation was a major limitation associated with the procedure. Then, fiber coils were introduced to overcome the problems of a detachable balloon, but they could not be replaced or removed in case of the inadequate shape of the coils. Therefore, embolization with flexible platinum coils has become the widely used procedure to treat intracranial aneurysms, and there is no better device than the WEB embolization System to generate safe and sound results. 

 

According to TechSci report, “Global Brain Implants Market By Product Type (Deep Brain Stimulators, Spinal Cord Stimulators, Vagus Nerve Stimulators) By Application (Chronic Pain, Epilepsy, Parkinson’s Disease, Depression, Essential Tremor, Alzheimer’s Disease) By End User (Hospitals & Clinics, Ambulatory Surgery Centers, Others) By Region, Competition Forecast & Opportunities, 2026”, the global brain implants market is anticipated to grow at a significant rate during the forecast period. The growth can be attributed to the rising population prone to neurological disorders and technical advances in brain implants. 

 

Another TechSci research report on “Global Deep Brain Stimulation (DBS) Devices Market By Product Type (Single-channel Deep Brain Stimulator, Dual-channel Deep Brain Stimulator), By Type (Rechargeable, Non-Rechargeable), By Application (Obsessive Compulsive Disorder, Parkinson’s Disease, Essential Tremor, Epilepsy, Dystonia, Others), By End User (Hospitals, Ambulatory Surgical Centers (ASCs), Neurological Clinic, Research Centers), By Region, Forecast & Opportunities, 2025”, the global deep brain stimulation devices market is anticipated to grow at a steady rate during the forecast period. The growth can be attributed to factors such as growing incidences of neurological disorders, rising prevalence of lifestyle diseases, and increasing investment in R&D activities in the neurological sector. 


Web:   https://www.techsciresearch.com/

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