The US Food and Drug Administration (FDA) has granted approval for an expanded indication of Medtronic’s Pipeline Flex embolisation device for brain aneurysms.
The previous indication for the device covered endovascular treatment of adults with large wide-necked intracranial aneurysms (IAs) present in the internal carotid artery from the petrous to the superior hypophyseal segments.
The new indication expands the scope to include small or medium, wide-necked brain aneurysms in the artery from the petrous to the terminus.
Embolisation is a method used to block abnormal blood vessels, which can be conducted with various materials.
Pipeline Flex diverts blood flow away from an aneurysm. It consists of a braided cylindrical mesh tube that is to be implanted across the base or neck of an aneurysm.
The embolisation device cuts off blood flow to the aneurysm and reconstructs the diseased section.
The FDA approval is based on results from the PREMIER trial conducted in 141 patients with a mean aneurysm size of 5.0±1.92mm to assess the safety and efficacy of Pipeline Flex.
Findings revealed one-year occlusion rates of 76.7% with the use of 1.1 device per participants on average and a 2.2% occurrence of major stroke or neurological death.
Medtronic Neurovascular business vice-president and general manager Stacey Pugh said: “Working hand-in-hand with physicians to develop new technology and clinical data is at the core of our mission.
“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.”
PREMIER is the second investigational device exemption (IDE) study for the embolization device.
The first five-year PUFs trial was performed for large and giant wide-necked aneurysms of the intracranial internal carotid artery (ICA).
In this study, efficacy rates were 70.8% at one year that increased to 95% in patients with angiographic follow up at the five year time period. The overall major stroke or neurological death occurrence was observed to be 5.6%.
The Pipeline Flex embolisation device is part of the Medtronic Restorative Therapies Group’s Neurovascular portfolio.