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The Medtronic product will now be available for use with patients with small or medium wide-necked aneurysms in the area from the petrous to the terminus of the internal carotid.
Ricardo Hanel, MD, PhD
The FDA has approved an expanded indication for the Pipeline Flex embolization device, according to manufacturer Medtronic. The device was 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.1
This new indication will now open the device up for patients with small or medium wide-necked aneurysms in the area from the petrous to the terminus of the internal carotid. Estimates have suggested that about 50,000 people die from ruptured brain aneurysms globally each year‚ with 50% of these patients under the age of 50 years.2
The approval was given based on data from the PREMIER trial (NCT02186561), which expanded the literature on the safety and efficacy of the device for this broader patient population. The trial included 141 patients with a mean aneurysm size of 5.0 ±19.2 mm and found that the use of 1.1 devices per person resulted in 1-year occlusion rates of 76.7%. The rate of major stroke or neurological death was 2.2%.3
Additionally, the attempted device success rate was 95.9%, with only 2.9% of patients requiring retreatment. No aneurysm recurrence was observed at 1-year post-procedure.
"PREMIER is another landmark study with Pipeline and moves the bar on the safe treatment of wide-necked brain aneurysms," Ricardo Hanel, MD, PhD, a neurosurgeon and the director of Stroke and Cerebrovascular Center at Baptist Health in Jacksonville, Florida, as well as principal investigator for the PREMIER trial, said in a statement. "This data [change] the way we, as physicians, think about using Pipeline Flex to treat our patients."
The Pipeline Flex device is designed to divert blood flow away from an aneurysm and features a braided cylindrical mesh tube which is implanted across the base of an aneurysm. By doing so, it cuts off the blood flow to it and reconstructs the diseased section of the parent vessel.
According to Medtronic, this was the second Investigational Device Exemption (IDE) study for the Pipeline Flex to gain FDA approval after completing the PUFs trial. PUFs was a 5-year study of the device with large and giant wide-necked aneurysms of the intracranial internal carotid artery. Efficacy rates in that trial were reported at 70.8% at 1 year, which then progressed to 95% in those with angiographic follow-up at 5 years. The overall occurrence of major stroke or neurological death was slightly higher than in PREMIER, at 5.6%.4
"Working hand-in-hand with physicians to develop new technology and clinical data is at the core of our mission,” said Stacey Pugh, the vice president and general manager of the Neurovascular business, part of the Restorative Therapies Group at Medtronic. “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.”
In the United States, the Pipeline Flex device is intended for use for the endovascular treatment of complex wide-necked intracranial aneurysms located in the internal carotid artery, attached to parent vessels measuring between 2.0 and 5.0 mm in diameter, according to Medtronic.
1. Medtronic Receives FDA Approval on Expanded Indication for Pipeline Flex Embolization Device [press release]. Dublin, Ireland: Medtronic; Published February 7, 2019. globenewswire.com/news-release/2019/02/07/1712036/0/en/Medtronic-Receives-FDA-Approval-on-Expanded-Indication-for-Pipeline-Flex-Embolization-Device.html. Accessed February 7, 2019.
2. Brain Aneurysm Statistics and Facts. Brain Aneurysm Foundation website. bafound.org/about-brain-aneurysms/brain-aneurysm-basics/brain-aneurysm-statistics-and-facts. Accessed February 7, 2019.
3. Clinical Evidence—Flow Diversion. Medtronic website. medtronic.com/us-en/healthcare-professionals/therapies-procedures/neurological/brain-aneurysm/clinical-evidence/flow-diversion.html. Accessed February 7, 2019.
4. Becske T, Brinjikji W, Potts MB, et al. Long-term clinical and angiographic outcomes following pipeline embolization device treatment of complex internal carotid artery aneurysms: five-year results of the pipeline for uncoilable or failed aneurysms trial. Neurosurgery. 2017;80(1):40-48. doi: 10.1093/neuros/nyw014.