News In Brief
This article was originally published in The Gray Sheet
Executive Summary
HeartWare HVAD submission
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Advisory panel review April 25 could pave the way for PMA approval this year as a bridge to heart transplant.
HeartWare Pipeline Update: HVAD On Track For 2012 PMA Approval
Firm notes that it has not yet heard from FDA on whether an advisory committee review will be required for its left ventricular assist device, intended as a bridge to transplant.
FDA Approves St. Jude’s Quadripolar CRT-D Device Following Delay
The approval is significant as it marks the entry of the first quadripolar pacing system into the U.S. market. But St. Jude may not get as big of a positive gain from the product as previously expected, analysts suggest.