Medtronic has received approval of an expanded indication from the FDA for its Pipeline Flex embolization device, for patients with smaller aneurysms found deeper in the brain.
The system was previously approved for endovascular treatment with large or giant, wide-necked intracranial aneurysms, located in the internal carotid artery from the petrous to the superior hypophyseal segments.
The new indication includes patients with small or medium brain aneurysms, from the petrous through to the terminus of the internal carotid artery, in parent blood vessels measuring between 2 mm and 5 mm in diameter.
The device is designed to divert blood away from an aneurysm, using a braided, cylindrical mesh tube implanted across the base of the aneurysm, to help reconstruct the damaged section of the blood vessel.
Its approval was based on a clinical study of 141 patients with an average aneurysm size of 5 millimeters. The study’s one-year occlusion rate reached 76.7%, with a 2.2% occurrence of major stroke or neurological death.
The device was originally approved after a five-year study of large or giant aneurysms, demonstrating efficacy rates from 70.8% at one year, to 95% after five years, with no documented cases of recurrence, according to Medtronic.