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FDA fast-tracks brain aneurysm stent


The FDA has given fast-tracked approval for a new microstent treatment for patients with brain aneurysms.

The Pipeline device from US-based Chestnut Medical Technologies is a bimetallic microstent with a braided structure that disrupts blood flow within the aneurysm neck, helping to preserve the artery.

The Agency has limited the use of Pipeline to aneurysms in the internal carotid artery, the major blood vessel supplying blood to the front of the brain.

Aneurysms occur when blood vessel walls weaken. Over 25,000 people in the US experience haemorrhages from a burst aneurysm every year, of which about 40% are fatal.

The Pipeline has a braided netting with 48 strands woven together. Introduced into the artery through a microcatheter, the Pipeline covers the aneurysm neck and reduces the flow of blood into it.

The trapped blood in the Pipeline clots, preventing the aneurysm from growing or rupturing.

They can be present for years without giving any symptoms, but the threat is that they will burst, which can be lethal.

Michael Marks, Chief of the Interventional Neuroradiology Department at Stanford Hospital, the first hospital in Northern California to offer the therapy, said: “We know that the device is safe in certain anatomy.

“As we learn more, there may be additional applications for a device like this. But our focus right now is treating those patients that we’ve had no good treatment for.”

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