FDA Approves Expanded Indication for Medtronic's Pipeline Flex Embolization Device
February 7, 2019—Medtronic announced that it has received FDA approval of an expanded indication for its Pipeline Flex embolization device. In the United States, the Pipeline Flex device is intended for use for the endovascular treatment of complex wide-necked intracranial aneurysms (IAs) located in the internal carotid artery (ICA), attached to parent vessels measuring between 2 and 5 mm in diameter.
According to the company, the device was previously indicated for the endovascular treatment of adults with large or giant wide-necked IAs in the ICA from the petrous to the superior hypophyseal segments. The new indication includes treatment of patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the ICA.
Medtronic advised that approval of the expanded indication was based on clinical data from the PREMIER trial, a prospective study of safety and efficacy of embolization of intracranial aneurysms with the Pipeline device for a broader patient population. Investigators analyzed data from 141 patients with a mean aneurysm size of 5 ± 1.92 mm. The 1-year occlusion rate was 76.7% with the use of 1.1 devices per patient on average and a 2.2% occurrence of major stroke or neurologic death.
Ricardo Hanel, MD, who serves as principal investigator for the PREMIER trial, commented in Medtronic's announcement, "PREMIER is another landmark study with Pipeline and moves the bar on the safe treatment of wide-necked brain aneurysms. This data change the way we, as physicians, think about using Pipeline Flex to treat our patients."