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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.

St. Jude Medical Inc.’s Unify Quadra became the first cardiac resynchronization therapy defibrillator system with a quadripolar pacing lead approved by FDA Nov. 29, at least six months behind the firm’s initial target date.

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