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Covidien Plans April U.S. Launch Of Solitaire For Ischemic Strokes

This article was originally published in The Gray Sheet

Executive Summary

Clot removal device gains 510(k) clearance earlier than expected, will compete with Stryker’s Merci clot retrieval system.

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Covidien Launches Study To Expand Indication For Pipeline Aneurysm Device

The firm hopes to support approval for use of the embolization device for smaller aneurysms and in more anatomical locations with data from its just-launched PREMIER trial. Also, Covidien announced the first patient in a new registry to track postmarket data, and hopefully support reimbursement, for its mechanical thrombectomy stroke devices including Solitaire 2.

Research in Brief

Covidien launches the SWIFT PRIME trial of its Solitaire FR mechanical thrombectomy device. PeriGen reports encouraging results from a validation study of its fetal heart rate monitoring software.

New Products In Brief

Recent debuts and approvals include Covidien’s AS Meniscal repair device, Medtronic’s Sentrino continuous glucose management system and Blue Belt’s NavioPFS system for partial knee replacement.

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