Study confirms safety of new flow-diverting stent to treat brain aneurysms


In England, ruptured brain aneurysms occur in around one in 15,000 people every year

Researchers from King’s College London’s (KCL) School of Biomedical Engineering and Imaging Sciences have confirmed the safety of a new flow-diverting stent device to prevent blood flow into brain aneurysms.

Published in the Journal of Neurointerventional Surgery, the study assessed the safety of the updated Pipeline Vantage Embolization Devices (PEDV) to treat the condition.

In England, every year, around one in 15,000 people have a ruptured brain aneurysm, a bulge in a blood vessel in the brain that can cause headaches, changes to vision and severe headaches if it ruptures.

The risk of an aneurysm rupture heightens when blood pressure in the blood vessels rises, causing them to grow and become thinner and weaker, which ultimately leads to their rupturing.

Researchers used data from eight hospitals to show how the second updated version of the PEDV was effective and safe when stopping the blood flow into aneurysms for patients with unruptured aneurysms.

PEDV is a flow-diverting stent that has a similar shape to an artery and covers the entrance to an aneurysm to prevent blood from entering.

The device consists of a metal tubular structure that is inserted into the arteries using catheters that have been navigated next to the brain aneurysm using image guidance.

Previously, the first version of PEDV was a limited pre-market release that had difficulties when placed into the artery, which led to its withdrawal from the market.

The new study has successfully provided evidence of the device since overcoming this issue with its second version, confirming it was safe and effective to use.

Dr Thomas Booth, reader in neuroimaging at KCL’s School of Biomedical Engineering and Imaging Sciences, said: “It is always vital to assess new devices in the clinic to assess and compare how effective they are in treating the disease and how safe they are for the patients. Overall, these are acceptable outcomes in this pragmatic and non-industry-sponsored study.”

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