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FDA Approves Medtronic's Embolization Device For Stopping Brain Aneurysms

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  • The FDA has approved Medtronic plc’s (NYSE: MDT) Pipeline Flex Embolization Device with Shield Technology, a chemically bonded, synthetic coating that helps camouflage the metal implant from blood cells and hides it from the body’s typical responses to an invading object.

  • The company celebrated the 10th anniversary of the implant when it was first introduced in the U.S, designed to divert blood flow away from a brain aneurysm and prevent its rupture.

  • The coating also makes the device slipperier, allowing it to slide more easily through curving vasculature during placement and deploy with less force than earlier generations.

  • Medtronic describes the latest version as the first surface-modified implant to show reductions in thrombogenicity, or the tendency for a material to create blood clots. The device’s first patient underwent treatment at NYU Langone Health.

  • In 2019, the company received approval of an expanded indication from the FDA for its Pipeline Flex embolization device for patients with smaller aneurysms found deeper in the brain.

  • Price Action: MDT shares are up 1.92% at $130.74 in market trading hours on the last check Wednesday.

Related content: Benzinga's Full FDA Calendar

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