FDA approves expanded indication for Pipeline Flex Embolization device

Medtronic has received FDA approval for an expanded indication for its Pipeline(TM) Flex embolization device which creates 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 Embolization of Intracranial aneurysms with the Pipeline(TM) 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±1.92 mm were analyzed. Data showed one-year occlusion rates of 76.7 percent with the use of 1.1 device per subject on average and a 2.2 percent occurrence of major stroke or neurological death.
Stacey Pugh, vice president and general manager of the Neurovascular business, part of the Restorative Therapies Group at Medtronic, 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.”
Dr. Ricardo Hanel, neurosurgeon, director of Stroke and Cerebrovascular Center at Baptist Health in Jacksonville, and principal investigator for the PREMIER trial, said: “PREMIER is another landmark study with Pipeline and moves the bar on the safe treatment of wide-necked brain aneurysms. This data changes the way we, as physicians, think about using Pipeline Flex to treat our patients.”