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Global Device Approvals, Weekly Snapshot: HeartMate 3 Reaches New Destination

 
• By David Filmore

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the additions, Abbott's HeartMate 3 left ventricular assist device gained "destination therapy" approval from US FDA, meaning its now vetted for use in patients who are not eligible for a heart transplant.

Approved

Three novel device or indication approvals were added to Medtech Insight's Approvals Tracker last week. US FDA "destination therapy" approval for Abbott Laboratories Inc.'s HeartMate 3 left-ventricular assist device was the most high-profile entry.

The approval means HeartMate 3 is now labeled to support advanced heart failure patients for the rest of their lives if they do not qualify for a heart transplant. The...

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