Advice
The technology
The technology
The pCONUS2 (Phenox) is an implantable intraluminal device for people with complex intracranial aneurysms. It is designed to support the coil occlusion of wide-necked aneurysms that span the division of an artery into 2 branches. The technology consists of a stent-like metal structure. At one end the stent has a crown of metal loops to anchor the implant to the neck of the aneurysm. The device is placed in the artery using a standard microcatheter (with an inner diameter of 0.533 mm). After placement, a microcatheter is used for coil occlusion of the aneurysm. The pCONUS2 is suitable for vessels between 2.50 mm and 3.70 mm in diameter and aneurysms with a neck of over 4 mm. The device has a shaft diameter and length of 4 mm and 15 mm, respectively. The crown diameter is available in sizes ranging from 5 mm to 15 mm.
The pCONUS2 is also available with a hydrophilic polymer coating (HPC). The company claims the coating avoids clots forming by preventing platelets from attaching to the stent and triggering blood to coagulate.
Innovations
The pCONUS2 has a less than 5% metal to artery surface ratio. The company claims this reduces the risk of thrombogenesis. The device has radiopaque markers along the shaft and in the loops of the crown intended to enhance visibility. The device is retrievable and detachable, which the company claims ensures optimal placement. The company also claims the device can be used without dual antiplatelet drugs, and allows for the coil occlusion of a complex intracranial aneurysm using 1 instead of 2 devices.
Current care pathway
Radiological imaging of the head, such as computerised tomography or computerised tomography angiography, is used to confirm the presence of an intracranial aneurysm.
Intracranial aneurysms can be treated surgically or using endovascular techniques.
Surgery traditionally involves accessing the aneurysm through an incision in the scalp in front of the ear and permanently clipping the neck of the aneurysm. Supraorbital minicraniotomy for intracranial aneurysm uses a smaller incision just above the eyebrow.
Endovascular techniques for treating intracranial aneurysms work by either blocking the aneurysm with a coil or by diverting the blood flow away from the aneurysm using a stent.
A catheter is used to insert a coil into the aneurysm sac to block the opening. Balloon-assisted treatment involves inflating a balloon temporarily inside the aneurysm sac to keep the coil open.
Alternatively, a stent placed across the neck of the aneurysm can direct blood flow into the parent vessel and away from the aneurysm, while providing a scaffold for endothelial growth to divert blood from the aneurysm sac. Multiple stents can be used to assist with wide-necked or bifurcated aneurysms, for example in Y-stenting or T-stenting. If stents are used, patients are given dual antiplatelet therapy to prevent in-stent thrombosis.
The following publications have been identified as relevant to this care pathway:
Population, setting and intended user
This technology is intended for people who need endovascular treatment of a wide-necked intracranial aneurysm. The technology would be used in secondary care by interventional neuroradiologists.
Costs
Technology costs
The pCONUS2 costs £6,760.00 (excluding VAT) without the HPC coating and £7,774.00 (excluding VAT) with the HPC coating.
Costs of standard care
The cost of standard care in neuro-interventional procedures depends on the complexity of the intracranial aneurysm. The approximate costs of the items needed for the different methods of treating an intracranial aneurysm are:
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clips used for surgery approximately £200
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balloon devices approximately £700
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stents for neuro-interventional procedures approximately £3,000
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Pipeline Flex embolisation device £10,450.