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Stryker Devices Get First-Line US FDA Go-Ahead For Stroke

 
• By Elizabeth Orr

It’s a first-in-class indication for clot-retrieval devices that the firm gained in a 2011 acquisition.

Stryker Neurovascular TrevoXP 4x20

Stryker Corp.'s Trevo clot-retrieval devices won de novo authorization from US FDA Sept. 2, the first time FDA has OK'd a device as a first-line treatment for ischemic stroke. The devices were developed by Concentric Medical Inc., which was acquired by Stryker for $135m in 2011. (Also see "Stryker Buys Concentric Medical To Enter Acute Ischemic Stroke Market" - Medtech Insight, 5 September, 2011.)

FDA’s move will allow the clot-retrieval devices, known as the Trevo ProVue and XP ProVue retrievers, to be used as...

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• By Natasha Barrow

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• By Natasha Barrow

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• By Amanda Maxwell

Modifying or doing away with the EU medtech recertification requirement is far from straightforward. Four experts from an EU national authority, an EU notified body trade association and industry, plus a well-known medtech consultant, reflect on how to move forward.