FDA Okays Pipeline Device for Small, Medium Brain Aneurysms

Disclosures

February 08, 2019

The US Food and Drug Administration (FDA) has approved the Pipeline Embolization Device (PED; Medtronic) for the additional indication of endovascular use in the treatment of small or medium-sized intracranial aneurysms.

The device, which is designed to divert blood flow away from an aneurysm, is already indicated for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.

The new indication now also includes patients with small or medium wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery, Medtronic reports.

The Pipeline Flex embolization device features a braided cylindrical mesh tube that is implanted across the base or neck of the aneurysm. The device cuts off blood flow to the aneurysm, reconstructing the diseased section of the parent vessel. It is also referred to as "flow diversion therapy."

The new indication is based on clinical data from the PREMIER trial, reported at the International Stroke Conference 2017, which included 141 patients with a mean aneurysm size of 5.0 mm. Results showed a 1-year occlusion rate of 76.7% with the use of 1.1 device per patient on average and a 2.2% occurrence of major stroke or neurological death.

An estimated 500,000 people throughout the world die each year because of ruptured brain aneurysms, with half the victims younger than 50 years of age.

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