Medtronic’s Pipeline Flex Embolization Device Receives FDA’s Expanded Indication Approval for Intracranial Aneurysms (IAs)

 Medtronic’s Pipeline Flex Embolization Device Receives FDA’s Expanded Indication Approval for Intracranial Aneurysms (IAs)

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

Click here to read full press release/ article | Ref: Medtronic | Image:  Yahoo Finance

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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