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Medtronic receives FDA approval on expanded indication for pipeline flex embolization device

Press releases may be edited for formatting or style | February 08, 2019 Cardiology

"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," said Stacey Pugh, vice president and general manager of the Neurovascular business, which is part of the Restorative Therapies Group at Medtronic.

In the United States, the Pipeline Flex device is intended for use for the endovascular treatment of complex wide-necked intracranial aneurysms located in the ICA, attached to parent vessels measuring between 2.0 and 5.0 mm in diameter.

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Flow diversion has been used to treat patients in the United States since 2011. This product is part of the Neurovascular portfolio in Medtronic's Restorative Therapies Group.


About Medtronic
Medtronic plc, headquartered in Dublin, Ireland, is among the world's largest medical technology, services, and solutions companies - alleviating pain, restoring health, and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals, and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

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