Medtronic Receives the US FDA's Approval for Pipeline Flex Embolization Device with Shield Technology
Shots:
- The US FDA has approved Pipeline Flex Embolization Device with a Shield Technology to advance flow diversion therapy that demonstrates a reduction in material thrombogenicity or a reduction in the tendency of the surface treatment material to create clots
- The first patient receives new shield surface modification at NYU Langone Health. The SHIELD study evaluates the safety and efficacy of third-generation pipeline embolization device with shield technology for intracranial aneurysms
- The SHIELD study results showed 77.2% complete aneurysm occlusion @12 mos.- 3.2% primary safety endpoint- and 93.1% complete wall apposition post-procedure
Ref: Medtronic | Image: Seeking Alpha
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