Medtronic has announced that it has received US Food and Drug Administration (FDA) approval on an expanded indication for its Pipeline Flex embolisation device. Previously 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 opens options for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery.
Approval was based on clinical data from the Prospective study on embolisation of intracranial aneurysms with the Pipeline Device (PREMIER) trial, which expands understanding of the safety and efficacy for this device for a broader patient population. A total of 141 subjects with a mean aneurysm size of 5.0±1.92mm were analysed. Data showed one-year occlusion rates of 76.7% with the use of 1.1 device per subject on average and a 2.2% occurrence of major stroke or neurological death.
Designed to divert blood flow away from an aneurysm, the Pipeline Flex embolisation 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. This is the second investigational device exemption (IDE) study for this implant which gained FDA approval after completing the ‘Pipeline for uncoilable or failed aneurysms’ (PUFs) trial, a five-year study for large and giant wide-necked aneurysms of the intracranial internal carotid artery (ICA) where efficacy rates were reported at 70.8% at one-year that progressed to 95% in subjects with angiographic follow up at the five-year time period. In the PUFs study the overall occurrence of major stroke or neurological death was 5.6%. There were no documented cases of aneurysm recurrence in patients treated with the implant.
“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 of the Neurovascular business, which is part of the Restorative Therapies Group at Medtronic.
In the USA, the Pipeline Flex device is intended for use for the endovascular treatment of complex wide-necked intracranial aneurysms located in the ICA, attached to parent vessels measuring between 2.0 and 5.0mm in diameter.