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The Food and Drug Administration (FDA) approved an expanded indication for an embolization device (Pipeline™ Flex; Medtronic, Dublin, Ireland) for the treatment of small to medium wide-necked intracranial aneurisms (IAs).
Previously the device was approved only for endovascular treatment of adults with large or giant wide-necked IAs in the internal carotid artery (ICA) from the petrous to the superior hypophyseal segments. The new indication gives options for patients with small or medium, wide-necked aneurysms in the territory from the petrous to the terminus of the ICA.
Approval was based on data from the PREMIER trial (NCT02186561) that evaluated the safety and efficacy of the device 141 patients with a mean aneurysm size of 5.0 ± 1.92 mm, and the 1-year occlusion rate was of 76.7% per subject with a 2.2% occurrence of major stroke or death.
Designed to divert blood flow away from an aneurysm, the device has 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.
"The PREMIER study not only demonstrated excellent safety and efficacy outcomes, but also delivered on our commitment to broadening access to innovative therapies for new groups of patients requiring aneurysm treatment," said Stacey Pugh, vice president and general manager, Medtronic.
Liana Rosenthal, MD, PhD
Serge Gauthier, CM, CQ, MD, FRCPC; and Pedro Rosa-Neto, MD, PhD
Peter McAllister, MD