Medtronic's Pipeline Flex Embolization Device Receives FDA's Expanded Indication Approval for Intracranial Aneurysms (IAs)
Shots:
- The expanded approval is based on PREMIER Trial assessing Pipeline Flex in 141 patients with mean aneurysm size of 5.0±1.92 mm
- The study resulted in one-year occlusion rates of 76.7% with use of 1.1 device & 2.2% occurrence of major stroke or neurological death and additional data from PUFs study with efficacy rates 70.8 % @ 1yr. extended to 95% @5yrs.
- Pipeline Flex is a medical device targeted for cardiovascular wide-neck IAs located in the ICA with expanded indication for small or medium IAs and is used to treat patients since 2011 in the US
Ref: Medtronic | Image: Yahoo Finance
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